臨床研究等提出・公開システム

A, randomized, double-blind, placebo-controlled pragmatic study to evaluate FINerenone on clinicAL effIcacy and safeTY in patients with Heart Failure and reduced ejection fraction who are intolerant of or not eligible for treatment with steroidal mineralocorticoid receptor antagonists (FINALITY-HF)

FINALITY-HF (FINALITY-HF)

Kato Eri

Kyoto University Hospital

54 Shogoin-kawahara-cho, Sakyo-ku, Kyoto 606-8507, Japan

erikato@kuhp.kyoto-u.ac.jp

Kanda Keiji

Kyoto University Hospital

54 Shogoin-kawahara-cho, Sakyo-ku, Kyoto 606-8507, Japan

+81-757514940

k_kanda@kuhp.kyoto-u.ac.jp

Recruiting

Feb. 17, 2025

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

prevention purpose

1.Provide electronic or written informed consent
2.Age 18 years or more
3.Symptomatic HFrEF (must meet all criteria)
a)NYHA class II-IV symptoms at screening and randomization
b)Most recent ejection fraction less than 40% by imaging within 12 months prior to screening
c)Most recent (within 14 days of randomization) N-terminal pro B-type natriuretic peptide (NTproBNP) 700 or more pg/mL or B-type natriuretic peptide (BNP) 175 pg/mL or more according to the local laboratory for patients without hospitalization for heart failure in the last 3 months (500 pg/mL or more or B-type natriuretic peptide (BNP) 125 pg/mL or more if hospitalized for heart failure within the last 3 months) for those without atrial fibrillation (AF). For patients with AF, or NTproBNP 1000 pg/mL or more or BNP 250 pg/mL or more regardless of history of hospitalization. If no value is available in the medical record, a local lab value must be obtained.
4.Not on sMRA due to documented history of being either intolerant, contraindicated or considered not eligible for treatment with sMRA (i.e., spironolactone, eplerenone or canrenone/potassium canrenoate).
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 adequate contraception which is consistent with local regulations regarding the methods for contraception for the duration of the study

1.Treatment with nsMRA, e.g., finerenone, esaxerenone, apararenone, within 30 days prior to randomization and treatment with any MRA should not be interrupted for the purpose of enrollment into the study
2.eGFR less than 25 mL/min/1.73m2 and / or serum/plasma potassium more than 5.0 mmol/L at screening, most recent value within 14 days of randomization if acutely hospitalized or discharged within the last 10 days and within 30 days if no recent hospitalization. Note. should be repeated if renin-angiotensin system antagonist started or dose increased since prior measurement.
3.Type 1 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.
4.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
5.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
6.Symptomatic bradycardia or second or third degree heart block without a pacemaker
7.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 congenital heart disease according to investigators judgement, or known pericardial constriction
8.Probable alternative cause of participants HF symptoms that, in the opinion of the investigator, primarily accounts for patient symptoms, specifically, patients with severe pulmonary disease requiring home oxygen or chronic oral steroid therapy, primary pulmonary arterial hypertension at screening
9.Concomitant systemic therapy with potent cytochrome P450 isoenzyme 3A4 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 Johns Wort, that cannot be discontinued 7 days prior to randomization and for the duration of the treatment period.
10.Any other condition or therapy, e.g., cardiogenic shock, clinically overt severe hepatic insufficiency, Addisons disease, malignancy or other severe condition as per investigators judgment such as disease with less than 1 year life expectancy, which would make the participant unsuitable for this study and not allow participation for the full planned study period
11.Concurrent participation in another interventional clinical study using an investigational agent, e.g. not approved for any indicatio

Heart falure

Participants will be randomized to Finerenone or placebo

heart failure, HFrEF, MRA, finerenone

MRA, non steroidal, finerenoe

The time to first occurrence of cardiovascular death or a heart failure event.

Total (first and subsequent) events of CV death and HF events
Total (first and subsequent) HF events
Change in KCCQ-TSS from baseline to Month 6
Time to CV death
Time to all-cause death.

+81-757513111

Jan. 24, 2025

No

USA/Brazil