The effect of sertraline on anxiety-depressive symptoms, endothelial dysfunction and biomarkers in heart failure patients with preserved ejection fraction

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Medical University Of Gdansk

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14], Psychiatry and Psychology [F] - Mental Disorders [F03]

Trial duration

22 Mar 2024 → 5 Dec 2025

Decision date (initial)

2024-12-09

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Medical Research Agency (Agencja Badań Medycznych)

External identifiers

EU CT number

2024-515061-33-00

EudraCT number

2022-000805-29

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Diagnosis

Assessment of time to hospitalization for cardiovascular reasons or death from any cause

Secondary objectives 1

1. 1. Assessment of the intensity of depressive and anxiety symptoms using the PHQ-9 and GAD-7 questionnaires, 2. Combined risk assessment of death or hospitalization from any cause. 3. Assessment of time to hospitalization for cardiovascular reasons 4. Assessment of time to hospitalization for any cause 5. Assessment of time to death from cardiovascular causes 6. Assessment of time to death from any cause 7. Assessment of quality of life using the SF12 mental test 8. Assessment of heart failure symptoms and angina 9. Assessment of endothelial function, inflammation and heart failure based on biomarkers 10. Assessment of endothelial function (FMD) and microcirculation (LSCI) 11. Assessment of systolic and diastolic heart function based on echocardiography

Conditions and MedDRA coding

Depressive-anxiety states in people with heart failure with preserved ejection fraction

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. a. Expression of willingness to participate in the study and after obtaining information about the study, signing an informed consent form to participate in the clinical trial; b. Patient age at enrollment ≥60 years and <85 years; c. Score ≥10 in the Patient Health Questionnaire PHQ-9 and/or score ≥10 in the Generalized Anxiety Disorder GAD-7; d. Documented diagnosis of HFpEF or new diagnosis of HFpEF based on obtaining ≥5 points according to the HFA-PEFF criteria by the investigator during the screening phase.

Exclusion criteria 1

1. a. Current participation in another clinical trial; b. Presence of suicidal behavior or thoughts in the period from 3 months preceding screening to the randomization visit – maximum score for question no. 9 in the PHQ-9 test; c. Blood Hb concentration <11.0 g/dl d. Abnormal renal function: blood creatinine concentration >2.0 mg/dl or eGFR <30 ml/min; e. Blood sodium concentration <130 mmol/l; f. Use of warfarin or acenocoumarol; g. Psychosis or bipolar disorder ever in the patient's medical records; h. Epilepsy or seizures ever in the patient's medical records; i. Use of antidepressants in the 4 weeks preceding screening; j. Diagnosed malignancy in the last 2 years before screening; k. Inability to attend all visits scheduled in the study; l. Angina symptoms ≥3 on the CCS scale; m. Revascularization or venous thromboembolism within 3 months prior to screening; n. Use of another study drug within 3 months prior to screening; o. Hemodynamically significant valvular disease or hypertrophic cardiomyopathy; p. Active infection as assessed by the investigator; q. Myocarditis or pericarditis within 1 year prior to screening; r. Significant atrial or ventricular septal defect; s. Cardiac amyloidosis in the patient's medical records; t. Severe ventricular arrhythmias; u. Uncontrolled blood pressure: SBP >170 or or DBP >100 mmHg at the screening or randomization visit; v. Resting heart rate (HR) >110/min or <50/min; w. Blood enzymatic activity ALAT or AST ≥3 times the upper limit of the reference range (UVR); x. Life expectancy of the patient <2 years; y. Organ transplant recipient; z. Severe dysfunction of the musculoskeletal system that prevents the patient from moving independently; aa. History of intolerance to sertraline or other SSRI drugs (treatment duration less than 8 weeks); bb. active gastric and/or duodenal ulcer; cc. history of gastrointestinal bleeding.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Time to hospitalization for cardiovascular reasons or death from any cause

Secondary endpoints 1

1. a. time to hospitalization for any cause, b. time to death for any cause, c. time to hospitalization for cardiovascular causes, d. time to death for cardiovascular causes, e. total time to death or hospitalization for any cause f. Change in the PHQ-9 and GAD-7 scale score from the last measurement before drug administration g. SF-12 scale score mental h.g. SF-12 mental score h. 8a. KCCQ-12 score 8b. NYHA class 8c. CCS class i. Level of biomarkers related to endothelial function

Investigational products

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

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Medical University Of Gdansk

Sponsor organisation

Medical University Of Gdansk

Address

Ul. Marii Sklodowskiej-Curie 3a

City

Gdansk

Postcode

80-210

Country

Poland

Scientific contact point

Organisation

Medical University Of Gdansk

Contact name

Chief Medical Officer, Principal Investigator

Public contact point

Organisation

Medical University Of Gdansk

Contact name

Director of Clinical Research Support Centre

Locations

1 EU/EEA country · 8 investigational sites

By country

Investigational sites

Country notifications

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

Results and documents

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

Documents 5 files

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

Application history

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