A Study to Evaluate Finerenone on Clinical Efficacy and Safety in Patients with Heart Failure Who Are Intolerant or Not Eligible for Treatment with Steroidal Mineralocorticoid Receptor Antagonists.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Colorado Prevention Center

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

1 Sep 2025 → ongoing

Decision date (initial)

2025-06-30

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2023-508875-35-00

ClinicalTrials.gov

NCT06033950

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

The primary objective is to evaluate the efficacy and safety of finerenone in participants with HFrEF who are intolerant of or not eligible for treatment with sMRA. The safety objective is to assess safety and tolerability of finerenone.

Conditions and MedDRA coding

Heart condition

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. 2. Age ≥18 years or legal age of majority if >18 years in the participant’s country of residence.
2. 3. Symptomatic HFrEF (must meet all criteria) • NYHA class II – IV symptoms at screening and randomization • Most recent ejection fraction <40% by imaging (e.g., echocardiogram, cardiac MRI, nuclear scan) within 12 months prior to screening • Qualifying natriuretic peptide level: Most recent local laboratory value within 14 days of randomization for patients with recent HHF (discharged within prior 10 days) or within 30 days for patients without recent HHF must meet the qualifying threshold below. If no value is available in the medical record, a local lab value must be obtained. Note: for participants treated with an angiotensin receptor/neprilysin inhibitor (ARNI) in the previous 4 weeks prior to natriuretic peptide measurement, only NTproBNP values should be used.
3. 4. Not on sMRA (i.e., spironolactone, eplerenone or canrenone/potassium canrenoate) due to documented history of being either intolerant, contraindicated (e.g., due to eGFR <30 mL/min/1.73m2) or considered ineligible for treatment with sMRA . • Intolerance is defined as at least one episode of hyperkalemia, or an episode of worsening kidney function, or an episode of sexual side effects or hypotension, each leading to drug interruption or discontinuation. • Ineligibility is in the opinion of the treating physician and/or investigator.
4. 5. Persons of childbearing potential can only be included in the study if a pregnancy test is negative at screening and if they agree to use highly effective contraception which is consistent with local regulations regarding the methods for contraception for the duration of the study.
5. 1. Provide written informed consent.

Exclusion criteria 13

1. 1. Treatment with any MRA (e.g., spironolactone, eplerenone, finerenone, esaxerenone, apararenone) within 30 days prior to randomization; treatment with any MRA should not be interrupted for the purpose of enrollment into the study.
2. 2. Documented prior history of severe hyperkalemia (potassium ≥6.0 mmol/L and/or resulting in hospitalization or Emergency Department visit) in the setting of MRA use
3. 3. eGFR <25 mL/min/1.73m² and / or potassium >5.0 mmol/L at screening (most recent value within 14 days of randomization if acutely hospitalized or discharged within the last 10 days; within 30 days of randomization if no recent hospitalization). Note: eGFR and potassium should be repeated prior to randomization if renin-angiotensin system antagonist started or dose increased since most recent prior measurement
4. 4. Acute MI, coronary revascularization, valve replacement/repair, or implantation of a cardiac resynchronization therapy device within 30 days prior to randomization or planned (note: pacemakers or implantable cardioverter defibrillators without resynchronization function are allowed)
5. 5. Prior heart transplant or listed for heart transplant with expectation to receive a transplant during the course of this trial (according to investigator judgement) or currently using or plan for mechanical circulatory support, e.g., left ventricular assist device, intra-aortic balloon pump, or participants on mechanical ventilation or participants with planned outpatient inotropic support
6. 6. Hemodynamically significant (severe) uncorrected primary cardiac valvular disease considered by the investigator to be the primary cause of heart failure (note: secondary mitral regurgitation or tricuspid regurgitation due to dilated cardiomyopathy is not excluded unless planned for surgery or intervention during the course of the study)
7. 7. Symptomatic bradycardia or second- or third-degree heart block without a pacemaker
8. 8. Cardiomyopathy due to known acute inflammatory heart disease (e.g., acute myocarditis within 90 days prior to randomization), infiltrative diseases (e.g., amyloidosis), accumulation diseases (e.g., haemochromatosis, Fabry disease), muscular dystrophies, cardiomyopathy with reversible causes (e.g., stress cardiomyopathy), known hypertrophic obstructive cardiomyopathy, complex (according to investigator`s judgement) congenital heart disease, or known pericardial constriction
9. 9. Probable alternative cause of participant’s HF symptoms that, in the opinion of the investigator, primarily accounts for patient’s symptoms; specifically, participants with severe pulmonary disease requiring home oxygen or chronic oral steroid therapy, primary pulmonary arterial hypertension at screening
10. 10. Concomitant treatment with: a) systemic potent cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors (e.g., itraconazole, ritonavir, indinavir, cobicistat, clarithromycin), or moderate CYP3A4 inducers (e.g., efavirenz, phenobarbital), or potent CYP3A4 inducers (e.g., carbamazepine, phenytoin, St John’s Wort) that cannot be discontinued 7 days prior to randomization and for the duration of the treatment period (note: a list of prohibited concomitant medications and excluded and allowed CYP3A4 inhibitors and inducers is provided in Appendix D); b) or a renin inhibitor or more than one of an angiotensin converting enzyme inhibitor (ACEi), angiotensin receptor blocker (ARB) or angiotensin-receptor-neprilysin-inhibitor (ARNI); c) or a potassium-sparing diuretic that cannot be stopped prior to randomization and for the duration of the treatment period.
11. 11. Known hypersensitivity to the IP (active substance or excipients)
12. 12. Any other condition or therapy (e.g., breastfeeding, cardiogenic shock, clinically overt severe hepatic insufficiency [Child Pugh C], Addison’s disease, malignancy or other severe condition as per investigator’s judgment such as disease with <1 year life expectancy) which would make the participant unsuitable for this study and not allow participation for the full planned study period
13. 13. Concurrent or previous participation in another interventional clinical study using an investigational agent (e.g., not approved for any indication) within 30 days or 5 half-lives of the study drug, whichever is longer, prior to randomization.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint is the time to first occurrence of cardiovascular death or a heart failure event.

Secondary endpoints 1

1. Secondary endpoints include treatment group differences in: Timing and occurrence of total (first and recurrent) events of cardiovascular (CV) death and heart failure (HF) events. Timing and occurrence of total (first and recurrent) HF events. Change in Kansas City Cardiomyopathy Questionnaire – Total Symptom Score (KCCQ-TSS) from baseline to Month 6. Time to CV death. Time to all-cause death.

Investigational products

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

Test 3

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Colorado Prevention Center

Sponsor organisation

Colorado Prevention Center

Address

2115 Scranton Street Suite 2040

City

Aurora

Postcode

80045-7120

Country

United States

Scientific contact point

Organisation

Colorado Prevention Center

Contact name

Marc Bonaca

Public contact point

Organisation

Colorado Prevention Center

Contact name

Marc Bonaca

Third parties 3

Locations

7 EU/EEA countries · 69 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 65 files

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

Application history

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