Pharmacological optimization in prevention in Heart Failure: A Sex-gap?

Start 8 May 2026 · Status Authorised, recruiting · 1 EU/EEA countries · 13 sites · Protocol AIFA-CARDIO-129

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)

Status Authorised, recruiting

Participants planned 368

Countries 1

Sites 13

Heart Failure

Key facts

Sponsor: Policlinico San Donato S.p.A.
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Female
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trial duration: 8 May 2026 → ongoing
Decision date (initial): 2025-11-17
Transition trial: No
Low-intervention: Yes
Rare-disease indication: No
Vulnerable population: No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy

Retrospective study
To better understand the implementation of the life-saving GDMT therapies and to fill in the sex-gaps.

Prospective study
To evaluate in a prospective pragmatic multi-centre trial, whether HF women at 12 months -follow-up, randomisation to up-titration of GDMT (following STRONG-HF titration programme) vs usual care may affect
a. Morbidity and mortality
b. Quality of life
c. Adherence to drug, as defined as suspension or dose reduction
d. Side-effects

Conditions and MedDRA coding

Heart Failure

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

Retrospective study All individuals with HF regardless of the left ventricular ejection fraction Prospective study 1. Female patients >18 <85 years 2. Hospital admission within the 24-48 hours prior to Screening for acute heart failure with dyspnea at rest and pulmonary congestion on chest X-ray, and other signs and/or symptoms of heart failure such as edema and/or positive rales on auscultation. 3. All measures within 24 hours prior to Randomization of systolic blood pressure ≥ 100 mmHg, and of heart rate ≥ 60 bpm. 4. All measures within 24 hours prior to Randomization of serum potassium ≤ 5.0 mEq/L (mmol/L). 5. Biomarker criteria for persistent congestion: 5.1. At Screening, NT-proBNP >1,800 pg/mL (2,350 pg/mL in case of atrial fibrillation) 5.2. At the time of Randomization (1-2 days prior to discharge), NT-proBNP >1,000 pg/mL (1,300 pg/mL in case of Atrial Fibrillation) to ensure the persistence of congestion and the acuity of the index episode). 6. At 1 week prior to admission, at Screening, and at Visit 2 6.1. If EF<50% (ie HFrEF or HFmrEF) either <½ the optimal dose of ACEi/ARB/ARNi and MRA and BB (see Table) must have been prescribed 6.2. If EF>50% (ie HFpEF): <½ the optimal dose of MRA (see Table) 7. Written informed consent to participate in the study.

Exclusion criteria 1

1. Male patients 2. Age < 18 or > 85 years. 3. Mechanical ventilation (not including CPAP/BIPAP) in the 24 hours prior to Screening. 4. Significant pulmonary disease contributing substantially to the patients’ dyspnoea such as FEV1 <1 liter or need for chronic systemic or nonsystemic steroid therapy, or any kind of primary right heart failure such as primary pulmonary hypertension or recurrent pulmonary embolism. 5. Myocardial infarction, unstable angina or cardiac surgery within 3 months, or cardiac resynchronization therapy (CRT) device implantation within 3 months, or percutaneous transluminal coronary intervention (PTCI), within 1 month prior to Screening or during the index event. 6. Index Event (admission for AHF) triggered primarily by a correctable aetiology such as significant arrhythmia (e.g., sustained ventricular tachycardia, or atrial fibrillation/flutter with sustained ventricular response >130 beats per minute, or bradycardia with sustained ventricular arrhythmia <45 beats per minute), infection, severe anaemia, acute coronary syndrome, pulmonary embolism, exacerbation of COPD, planned admission for device implantation or severe non-adherence leading to very significant fluid accumulation prior to admission and brisk diuresis after admission. Troponin elevations without other evidence of an acute coronary syndrome are not an exclusion. 7. Uncorrected thyroid disease, active myocarditis, or known amyloid or hypertrophic obstructive cardiomyopathy. 8. History of heart transplant or on a transplant list or using or planned to be implanted with a ventricular assist device. 9. Sustained ventricular arrhythmia with syncopal episodes within the 3 months prior to screening that is untreated. 10. Presence at Screening of any hemodynamically significant valvular stenosis or regurgitation, except mitral or tricuspid regurgitation secondary to left ventricular dilatation, or the presence of any hemodynamically significant obstructive lesion of the left ventricular outflow tract. 11. Active infection at any time during the AHF hospitalization prior to Randomization based on abnormal temperature and elevated WBC or need for intravenous antibiotics. 12. Stroke or TIA within the 3 months prior to Screening. 13. Primary liver disease considered to be life threatening. 14. Renal disease or eGFR < 30 mL/min/1.73m2 (as estimated by the simplified MDRD formula) at Screening or history of dialysis. 15. Psychiatric or neurological disorder, cirrhosis, or active malignancy leading to a life expectancy < 6 months. 16. Prior (defined as less than 30 days from screening) or current enrollment in a CHF trial or participation in an investigational drug or device study within the 30 days prior to screening 17. Discharge for the AHF hospitalization anticipated to be >14 days from admission, or to a long-term care facility. Randomization must occur within 12 days following admission and at 1-2 days prior to anticipated discharge. 18. Inability to comply with all study requirements, due to major co-morbidities, social or financial issues or a history of noncompliance with medical regimens, that might compromise the patient’s ability to understand and/or comply with the protocol instructions or follow-up procedures 19. Pregnant or nursing (lactating) women.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

Retrospective study: an up-to-date description of the “status quo” of the prescription of GDMT nationally and related inequality regarding sex in patients with HF based on analyses of National Registry data and Mecki Data-base. Prospective study: • all-cause mortality within 1 year or HF readmission or worsening HF.

Secondary endpoints 1

Prospective study: a.the percentage of optimization of each single medical therapy (BB; ACEi, ARB or ARNi;and MRAs and SGLT2i)in women admitted with heart failure, b.effect of such intervention at 1 year:mortality;HF re-admission;worsening HF;quality of life (EQ-5D questionnaire). c.Other endpoints:include changes in biomarkers and changes in the primary and secondary endpoints in pre-determined subgroups including <50vs>50 EF;>vs<65 yr old,presence of diabetes,chronic kidney disease or obesity

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 26

Losartan

SUB08593MIG · Substance

Active substance: Losartan
Pharmaceutical form: FILM COATED TABLET
Route of administration: BUCCAL USE
Max daily dose: 50 mg milligram(s)
Max total dose: 50 mg milligram(s)
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Losartan

SUB08593MIG · Substance

Active substance: Losartan
Pharmaceutical form: FILM COATED TABLET
Route of administration: BUCCAL USE
Max daily dose: 100 mg milligram(s)
Max total dose: 100 mg milligram(s)
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Dapagliflozin

SUB31650 · Substance

Active substance: Dapagliflozin
Pharmaceutical form: FILM-COATED TABLET
Route of administration: BUCCAL USE
Max daily dose: 10 mg milligram(s)
Max total dose: 10 mg milligram(s)
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Eplerenone

SUB06574MIG · Substance

Active substance: Eplerenone
Pharmaceutical form: FILM-COATED TABLET
Route of administration: BUCCAL USE
Max daily dose: 50 mg milligram(s)
Max total dose: 50 mg milligram(s)
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Spironolactone

SUB10631MIG · Substance

Active substance: Spironolactone
Pharmaceutical form: CAPSULE, HARD
Route of administration: BUCCAL USE
Max daily dose: 25 mg milligram(s)
Max total dose: 25 mg milligram(s)
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Perindopril

SUB09730MIG · Substance

Active substance: Perindopril
Pharmaceutical form: TABLET
Route of administration: BUCCAL USE
Max daily dose: 8 mg milligram(s)
Max total dose: 8 mg milligram(s)
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Ramipril

SUB10248MIG · Substance

Active substance: Ramipril
Pharmaceutical form: TABLETS
Route of administration: BUCCAL USE
Max daily dose: 10 mg milligram(s)
Max total dose: 10 mg milligram(s)
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Bisoprolol

SUB13096MIG · Substance

Active substance: Bisoprolol
Pharmaceutical form: FILM-COATED TABLET
Route of administration: BUCCAL USE
Max daily dose: 10 mg milligram(s)
Max total dose: 10 mg milligram(s)
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Trandolapril

SUB11212MIG · Substance

Active substance: Trandolapril
Pharmaceutical form: CAPSULE, HARD
Route of administration: BUCCAL USE
Max daily dose: 4 mg milligram(s)
Max total dose: 4 mg milligram(s)
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Canrenone

SUB06076MIG · Substance

Active substance: Canrenone
Pharmaceutical form: CAPSULE, HARD
Route of administration: BUCCAL USE
Max daily dose: 100 mg milligram(s)
Max total dose: 100 mg milligram(s)
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Fosinopril

SUB13918MIG · Substance

Active substance: Fosinopril
Pharmaceutical form: TABLET
Route of administration: BUCCAL USE
Max daily dose: 40 mg milligram(s)
Max total dose: 40 mg milligram(s)
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Lisinopril

SUB08533MIG · Substance

Active substance: Lisinopril
Pharmaceutical form: TABLET
Route of administration: BUCCAL USE
Max daily dose: 35 mg milligram(s)
Max total dose: 35 mg milligram(s)
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Finerenone

SUB183743 · Substance

Active substance: Finerenone
Pharmaceutical form: FILM-COATED TABLET
Route of administration: BUCCAL USE
Max daily dose: 20 mg milligram(s)
Max total dose: 20 mg milligram(s)
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Enalapril

SUB06514MIG · Substance

Active substance: Enalapril
Pharmaceutical form: TABLET
Route of administration: BUCCAL USE
Max daily dose: 40 mg milligram(s)
Max total dose: 40 mg milligram(s)
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Irbesartan

SUB08293MIG · Substance

Active substance: Irbesartan
Pharmaceutical form: FILM COATED TABLETS
Route of administration: BUCCAL USE
Max daily dose: 300 mg milligram(s)
Max total dose: 300 mg milligram(s)
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Potassium Canrenoate

SUB09983MIG · Substance

Active substance: Potassium Canrenoate
Pharmaceutical form: TABLET
Route of administration: BUCCAL USE
Max daily dose: 100 mg milligram(s)
Max total dose: 100 mg milligram(s)
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Nebivolol

SUB09175MIG · Substance

Active substance: Nebivolol
Pharmaceutical form: TABLETS
Route of administration: BUCCAL USE
Max daily dose: 10 mg milligram(s)
Max total dose: 10 mg milligram(s)
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Metoprolol

SUB14568MIG · Substance

Active substance: Metoprolol
Pharmaceutical form: TABLET
Route of administration: BUCCAL USE
Max daily dose: 200 mg milligram(s)
Max total dose: 200 mg milligram(s)
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Carvedilol

SUB06153MIG · Substance

Active substance: Carvedilol
Pharmaceutical form: TABLET
Route of administration: BUCCAL USE
Max daily dose: 100 mg milligram(s)
Max total dose: 100 mg milligram(s)
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Empagliflozin

SUB35915 · Substance

Active substance: Empagliflozin
Pharmaceutical form: FILM-COATED TABLET
Route of administration: BUCCAL USE
Max daily dose: 10 mg milligram(s)
Max total dose: 10 mg milligram(s)
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Valsartan

SUB00017MIG · Substance

Active substance: Valsartan
Pharmaceutical form: FILM-COATED TABLET
Route of administration: BUCCAL USE
Max daily dose: 320 mg milligram(s)
Max total dose: 320 mg milligram(s)
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Olmesartan

SUB20707 · Substance

Active substance: Olmesartan
Pharmaceutical form: FILM-COATED TABLET
Route of administration: BUCCAL USE
Max daily dose: 40 mg milligram(s)
Max total dose: 40 mg milligram(s)
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Quinapril

SUB10201MIG · Substance

Active substance: Quinapril
Pharmaceutical form: FILM COATED TABLET
Route of administration: BUCCAL USE
Max daily dose: 40 mg milligram(s)
Max total dose: 40 mg milligram(s)
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Captopril

SUB06081MIG · Substance

Active substance: Captopril
Pharmaceutical form: TABLET
Route of administration: BUCCAL USE
Max daily dose: 50 mg milligram(s)
Max total dose: 50 mg milligram(s)
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sacubitril Valsartan

SUB171905 · Substance

Active substance: Sacubitril Valsartan
Pharmaceutical form: FILM-COATED TABLET
Route of administration: BUCCAL USE
Max daily dose: 400 mg milligram(s)
Max total dose: 400 mg milligram(s)
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Candesartan

SUB06070MIG · Substance

Active substance: Candesartan
Pharmaceutical form: TABLET
Route of administration: BUCCAL USE
Max daily dose: 32 mg milligram(s)
Max total dose: 32 mg milligram(s)
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Comparator 26

Eplerenone

SUB06574MIG · Substance

Active substance: Eplerenone
Pharmaceutical form: FILM-COATED TABLET
Route of administration: BUCCAL USE
Max daily dose: 25 mg milligram(s)
Max total dose: 25 mg milligram(s)
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Valsartan

SUB00017MIG · Substance

Active substance: Valsartan
Pharmaceutical form: FILM COATED TABLETS
Route of administration: BUCCAL USE
Max daily dose: 160 mg milligram(s)
Max total dose: 160 mg milligram(s)
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Enalapril

SUB06514MIG · Substance

Active substance: Enalapril
Pharmaceutical form: TABLET
Route of administration: BUCCAL USE
Max daily dose: 20 mg milligram(s)
Max total dose: 20 mg milligram(s)
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Canrenone

SUB06076MIG · Substance

Active substance: Canrenone
Pharmaceutical form: TABLET
Route of administration: BUCCAL USE
Max daily dose: 50 mg milligram(s)
Max total dose: 50 mg milligram(s)
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Potassium Canrenoate

SUB09983MIG · Substance

Active substance: Potassium Canrenoate
Pharmaceutical form: TABLET
Route of administration: BUCCAL USE
Max daily dose: 50 mg milligram(s)
Max total dose: 50 mg milligram(s)
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Losartan

SUB08593MIG · Substance

Active substance: Losartan
Pharmaceutical form: FILM-COATED TABLET
Route of administration: BUCCAL USE
Max daily dose: 50 mg milligram(s)
Max total dose: 50 mg milligram(s)
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Losartan

SUB08593MIG · Substance

Active substance: Losartan
Pharmaceutical form: FILM-COATED TABLET
Route of administration: BUCCAL USE
Max daily dose: 25 mg milligram(s)
Max total dose: 25 mg milligram(s)
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Perindopril

SUB09730MIG · Substance

Active substance: Perindopril
Pharmaceutical form: TABLET
Route of administration: BUCCAL USE
Max daily dose: 4 mg milligram(s)
Max total dose: 4 mg milligram(s)
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Spironolactone

SUB10631MIG · Substance

Active substance: Spironolactone
Pharmaceutical form: CAPSULE, HARD
Route of administration: BUCCAL USE
Max daily dose: 25 mg milligram(s)
Max total dose: 25 mg milligram(s)
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Lisinopril

SUB08533MIG · Substance

Active substance: Lisinopril
Pharmaceutical form: TABLET
Route of administration: BUCCAL USE
Max daily dose: 16.5 mg milligram(s)
Max total dose: 16.5 mg milligram(s)
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Quinapril

SUB10201MIG · Substance

Active substance: Quinapril
Pharmaceutical form: FILM COATED TABLET
Route of administration: BUCCAL USE
Max daily dose: 20 mg milligram(s)
Max total dose: 20 mg milligram(s)
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Nebivolol

SUB09175MIG · Substance

Active substance: Nebivolol
Pharmaceutical form: TABLETS
Route of administration: BUCCAL USE
Max daily dose: 5
Max total dose: 5
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Carvedilol

SUB06153MIG · Substance

Active substance: Carvedilol
Pharmaceutical form: TABLET
Route of administration: BUCCAL USE
Max daily dose: 50 mg milligram(s)
Max total dose: 50 mg milligram(s)
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Captopril

SUB06081MIG · Substance

Active substance: Captopril
Pharmaceutical form: TABLET
Route of administration: BUCCAL USE
Max daily dose: 25 mg milligram(s)
Max total dose: 25 mg milligram(s)
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Ramipril

SUB10248MIG · Substance

Active substance: Ramipril
Pharmaceutical form: TABLET
Route of administration: BUCCAL USE
Max daily dose: 5 mg milligram(s)
Max total dose: 5 mg milligram(s)
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sacubitril Valsartan

SUB171905 · Substance

Active substance: Sacubitril Valsartan
Pharmaceutical form: FILM-COATED TABLET
Route of administration: BUCCAL USE
Max daily dose: 200 mg milligram(s)
Max total dose: 200 mg milligram(s)
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Metoprolol

SUB14568MIG · Substance

Active substance: Metoprolol
Pharmaceutical form: TABLET
Route of administration: BUCCAL USE
Max daily dose: 100 mg milligram(s)
Max total dose: 100 mg milligram(s)
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Dapagliflozin

SUB31650 · Substance

Active substance: Dapagliflozin
Pharmaceutical form: FILM-COATED TABLET
Route of administration: BUCCAL USE
Max daily dose: 10 mg milligram(s)
Max total dose: 10 mg milligram(s)
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Candesartan

SUB06070MIG · Substance

Active substance: Candesartan
Pharmaceutical form: TABLET
Route of administration: BUCCAL USE
Max daily dose: 16 mg milligram(s)
Max total dose: 16 mg milligram(s)
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Olmesartan

SUB20707 · Substance

Active substance: Olmesartan
Pharmaceutical form: FILM COATED TABLET
Route of administration: BUCCAL USE
Max daily dose: 20 mg milligram(s)
Max total dose: 20 mg milligram(s)
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Trandolapril

SUB11212MIG · Substance

Active substance: Trandolapril
Pharmaceutical form: CAPSULE, HARD
Route of administration: BUCCAL USE
Max daily dose: 2 mg milligram(s)
Max total dose: 2 mg milligram(s)
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Bisoprolol

SUB13096MIG · Substance

Active substance: Bisoprolol
Pharmaceutical form: FILM-COATED TABLET
Route of administration: BUCCAL USE
Max daily dose: 5 mg milligram(s)
Max total dose: 5 mg milligram(s)
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Irbesartan

SUB08293MIG · Substance

Active substance: Irbesartan
Pharmaceutical form: FILM COATED TABLET
Route of administration: BUCCAL USE
Max daily dose: 150 mg milligram(s)
Max total dose: 150 mg milligram(s)
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Fosinopril

SUB13918MIG · Substance

Active substance: Fosinopril
Pharmaceutical form: TABLET
Route of administration: BUCCAL USE
Max daily dose: 20 mg milligram(s)
Max total dose: 20 mg milligram(s)
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Finerenone

SUB183743 · Substance

Active substance: Finerenone
Pharmaceutical form: FILM-COATED TABLET
Route of administration: BUCCAL USE
Max daily dose: 10 mg milligram(s)
Max total dose: 10 mg milligram(s)
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Empagliflozin

SUB35915 · Substance

Active substance: Empagliflozin
Pharmaceutical form: FILM-COATED TABLET
Route of administration: BUCCAL USE
Max daily dose: 10 mg milligram(s)
Max total dose: 10 mg milligram(s)
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Policlinico San Donato S.p.A.

Sponsor organisation: Policlinico San Donato S.p.A.
Address: Piazza Edmondo Malan 2
City: San Donato Milanese
Postcode: 20097
Country: Italy

Scientific contact point

Organisation: Policlinico San Donato S.p.A.
Contact name: PI

Public contact point

Organisation: Policlinico San Donato S.p.A.
Contact name: PI

Locations

1 EU/EEA country · 13 investigational sites

By country

Country	MS status	Planned subjects	Sites
Italy	Authorised, recruiting	368	13
Rest of world	—	0	—

Investigational sites

Italy

13 sites · Authorised, recruiting

Azienda USL Toscana Nord Ovest - Ospedale di Cecina

UOC Cardiologia UTIC and UOS Riabilitazione Cardiologica, Via Montanara 52B, 57023, Cecina

Azienda Sanitaria Locale Bari

U.O.C di Cardiologia- UTIC, Via Caposcardicchio S/N, 70132, Bari

Azienda Ospedaliero Universitaria Delle Marche

Scienze Cardiovascolari- SOD Cardiologia Ospedaliera e UTIC, Via Conca 71, 60126, Ancona

Ospedale Santa Maria delle Croci

UOC di Cardiologia, V. Le Randi 5, 48121, Ravenna

Fondazione Toscana Gabriele Monasterio

U.O. Complessa di Cardiologia e Medicina Cardiovascolare, Via Giuseppe Moruzzi 1, 56124, Pisa

Azienda USL Toscana Centro

SOC Cardiologia Firenze I, Piazza Di Santa Maria Nuova 1, 50122, Florence

Policlinico San Donato S.p.A.

Cardiologia Universitaria Perioperatoria e Riabilitativa, Piazza Edmondo Malan 2, 20097, San Donato Milanese

Centro Cardiologico Monzino S.p.A.

Cardiologia Critica e Riabilitativa, Via Carlo Parea 4, 20138, Milan

University Hospital Of Ferrara

U.O. Cardiologia, Via Aldo Moro 8, 44124, Ferrara

Azienda USL IRCCS Di Reggio Emilia

Medicine specialistiche, Via Giovanni Amendola 2, 42122, Reggio Emilia

Istituto Auxologico Italiano

Cardiologica-Auxologico San Luca, Piazzale Brescia 20, 20149, Milan

Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon

Dipartimento Scienze Cardiologiche –Università Campus Bio‑Medico, Via Alvaro Del Portillo N 200, 00128, Rome

San Camillo Forlanini Hospital

Cardiologia, Circonvallazione Gianicolense 87, 00152, Rome

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country	Trial start	Trial end	Recruitment start	Recruitment end	Early termination
Italy	2026-05-08

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 13 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Type	Title	Version
Protocol (for publication)	Pop HF trial _Study Protocol_v1_18042025 - for publication	4
Recruitment arrangements (for publication)	PopS-HF Trial_informedconsent_patientrecruitmentprocedure - for publication	2
Subject information and informed consent form (for publication)	PopS-HF Trial_Informativa_consenso_v1_18042025 - for publication	3
Subject information and informed consent form (for publication)	PopS-HF Trial_Lettera_medico_curante_v1_18042025 - for publication	1
Subject information and informed consent form (for publication)	PopS-HF Trial_PRIVACY_Informativa_consenso_v1_18042025 - for publication	1
Subject information and informed consent form (for publication)	PopS-HF Trial_PRIVACY_Informativa_web_v1_18042025 - for publication	1
Summary of Product Characteristics (SmPC) (for publication)	RCP_Canrenoato di potassio	1
Synopsis of the protocol (for publication)	Pop HF trial _Synopsis_v1_18042025_ENG - for publication	1
Synopsis of the protocol (for publication)	Pop HF trial _Synopsis_v2_10102025_ENG - for publication	2
Synopsis of the protocol (for publication)	Pop HF trial _Synopsis_v3_10112025_ENG - for publication	3
Synopsis of the protocol (for publication)	Pop HF trial _Synopsis_v4_19112025_ENG - for publication	4
Synopsis of the protocol (for publication)	PopS-HF Trial_Sinossi_v1_18042025_ITA - for publication	3.0
Synopsis of the protocol (for publication)	PopS-HF Trial_Sinossi_v2_10102025_ITA	3.0

Application history

2 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2025-07-29	Italy	Acceptable with conditions 2025-11-14	2025-11-17
2	SUBSTANTIAL MODIFICATION	SM-1	2025-11-27	Italy	Acceptable 2026-03-23	2026-03-30

Pharmacological optimization in prevention in Heart Failure: A Sex-gap?

Overview

Key facts

Trial design

Main objective

Conditions and MedDRA coding

Eligibility criteria

Inclusion criteria 1

Exclusion criteria 1

Endpoints

Primary endpoints 1

Secondary endpoints 1

Investigational products

Test 26

Comparator 26

Sponsors and contacts

Policlinico San Donato S.p.A.

Scientific contact point

Public contact point

Locations

By country

Investigational sites

Country notifications

Results and documents

Documents 13 files

Application history

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