FINERENONE for Heart failure | Acute heart failure

Inclusion criteria

• {"criterion_text":"- 2. Age ≥18 years or legal age of majority if >18 years in the participant’s country of residence.\n- 3. Current hospitalization or recently discharged with a primary diagnosis of acute HF.\n- 4. Heart failure signs and symptoms at the time of hospital admission, including: a. Symptoms (at least one of the following): persistent dyspnea at rest or with minimal exertion worse than baseline or new or worsening orthopnea, and; b. Signs of fluid overload (at least one of the following): congestion on chest X-ray, rales on chest auscultation, clinically relevant edema caused by HF (as judged by the investigator), elevated jugular venous pressure.\n- 5. Elevated N-terminal pro B-type natriuretic peptide (NTproBNP) ≥500 pg/mL or B-type natriuretic peptide (BNP) ≥125 pg/mL according to the local lab for patients in sinus rhythm; or elevated NTproBNP ≥1500 pg/mL or BNP ≥375 pg/mL for patients with atrial fibrillation (AF), measured during the current hospitalization, in the 72 hours prior to hospital admission, or during the XY post-discharge. (Note: for patients treated with an angiotensin receptor neprilysin inhibitor [ARNI] in the previous 4 weeks prior to randomization, NTproBNP values should be used where available.)\n- 6. Fulfillment of the following stabilization criteria (if randomized during hospitalization): a. Systolic BP ≥100 mmHg and no symptoms of hypotension in the 6 hours prior to randomization. b. No increase in intravenous diuretic dose for 6 hours prior to randomization. c. No intravenous vasodilators, including nitrates, within the last 6 hours prior to randomization. d. No intravenous inotropic drugs or mechanical circulatory support for 24 hours prior to randomization.\n- 7. Treatment during the index hospitalization with at least 1 intravenous dose of a loop diuretic (e.g., furosemide, torsemide, bumetanide).\n- 8. Women of childbearing potential can only be included in the study if a pregnancy test is negative at screening and if they agree to use effective contraception which is consistent with local regulations regarding the methods for contraception for the duration of the study.\n- 1. Provide written informed consent."}

Exclusion criteria

• {"criterion_text":"- Diagnosis of type 1 diabetes or prior history of diabetic ketoacidosis.\n- Concomitant systemic therapy with 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 excluded CYP3A4 inhibitors and inducers is provided in Appendix D.) Concomitant treatment with renin inhibitor, more than one angiotensin converting enzyme inhibitor (ACEi), angiotensin receptor blocker (ARB) or ARNI, or with a potassium-sparing diuretic that cannot be stopped prior to randomization and for the duration of the treatment period.\n- Known hypersensitivity to finerenone or empagliflozin (active substance or excipients).\n- Any other condition or therapy (e.g., breastfeeding, cardiogenic shock, clinically overt severe hepatic insufficiency [Child Pugh C], Addison’s disease, 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.\n- Concurrent 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 other study intervention, whichever is longer, prior to randomization.\n- 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.\n- Currently on or planned for long-term therapy with non-steroidal MRA (finerenone, esaxerenone, apararenone, balcinrenone), steroidal MRA (spironolactone, eplerenone, canrenone), or SGLT2i. Potential participants should not have MRA or SGLT2i stopped for the purpose of enrollment into the study. Patients with recent MRA exposure should not be randomized or receive study treatment until 7 days from the last dose to allow adequate washout.\n- eGFR <30 mL/min/1.73m² and/or potassium >5.0 mmol/L at screening.\n- Acute MI due to plaque rupture, coronary revascularization, valve replacement/repair, or implantation of a cardiac resynchronization therapy device within 30 days prior to randomization. (Note: pacemakers or implantable cardioverter defibrillators without resynchronization function are allowed.)\n- 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 patients on mechanical ventilation or patients with planned outpatient inotropic support.\n- Hemodynamically significant (severe) uncorrected primary cardiac valvular disease considered by the investigator to be the primary cause of HF. (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.)\n- 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.\n- Probable alternative cause of participant’s HF symptoms that, in the opinion of the investigator, primarily accounts for patient’s symptoms; specifically, patients with severe pulmonary disease requiring home oxygen or chronic oral steroid therapy, primary pulmonary arterial hypertension at screening."}

Primary endpoints

• {"endpoint_text":"- The primary endpoint is clinical benefit, defined as a hierarchical composite endpoint of: 1. Time to all-cause mortality 2. Number of total HF events 3. Time to first HF event 4. KCCQ-TSS change from baseline to 6 months of 5 points or greater assessed by the win-ratio method","definition_or_measurement_approach":"Hierarchical composite assessed using the win-ratio method comprising (1) time to all-cause mortality, (2) number of total heart failure events, (3) time to first heart failure event, and (4) change from baseline in KCCQ-TSS to 6 months of ≥5 points."}

Secondary endpoints

• {"endpoint_text":"- Secondary endpoints include treatment group difference in: • KCCQ-TSS, mean change from baseline to 6 months • Time to first occurrence of all-cause mortality or HF event (hospitalization for HF or urgent visit due to HF) • Total (first and recurrent) HF events from baseline to 90 days","definition_or_measurement_approach":"Mean change in KCCQ-TSS from baseline to 6 months; time-to-event analysis for first occurrence of all-cause mortality or HF event (hospitalisation for HF or urgent HF visit); total (first and recurrent) HF events counted from baseline to 90 days."}

Spain

Earliest CTIS Part Ii Submission Date

29-01-2025

Latest Decision Or Authorization Date

08-05-2026

Processing Time Days

464

Number Of Sites

10

Number Of Participants

150

Primary sponsor

Full Name

Colorado Prevention Center

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

United States

Contract research organisations

Name

Emerald Clinical Trials B.V.

Responsibilities

sponsorDuties codes: 1,2,5,8

Name

SanaClis s.r.o.

Responsibilities

sponsorDuties code: 12

Third parties

• {"country":"Netherlands","full_name":"Emerald Clinical Trials B.V.","duties_or_roles":"sponsorDuties codes: 1,2,5,8","organisation_type":"Pharmaceutical company"}
• {"country":"Slovakia","full_name":"SanaClis s.r.o.","duties_or_roles":"sponsorDuties code: 12","organisation_type":"Pharmaceutical company"}