A Study to Determine the Efficacy and Safety of Finerenon... | NCT06008197

Studies
A Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients

NCT06008197

Sponsor

Colorado Prevention Center

Status

Recruiting

Last Update Posted

Jul 6, 2026Actual

Enrollment

5,200Estimated

Phase

Phase 3

Conditions

Heart Failure
Acute Heart Failure

Interventions

Finerenone
Placebo

Countries

United States
Argentina
Australia
Brazil
Canada
Croatia
Czechia
Germany
Greece
Hungary
India
Italy
Lithuania
Malaysia
Mexico
Peru
Poland
South Korea
Spain
Sri Lanka
Taiwan
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jul 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 17, 2024Actual

Primary Completion Date

Nov 2027Estimated

Completion Date

Dec 2027Estimated

First Submitted Date

Jul 31, 2023

First Submission Date that Met QC Criteria

Aug 15, 2023

First Posted Date

Aug 23, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 2, 2026

Last Update Posted Date

Jul 6, 2026Actual

Name	Class
St. Luke's Hospital, Kansas City, Missouri	OTHER
Bayer	INDUSTRY

Description Module

Brief Summary

Finerenone will be compared to placebo to determine efficacy and safety of treatment in patients hospitalized with acute decompensated heart failure (HF) and mildly reduced or preserved left ventricular ejection fraction.

Detailed Description

This is an international, randomized, double-blind, placebo-controlled, event-driven trial of finerenone for the treatment of hospitalized heart failure patients with mildly reduced or preserved ejection fraction.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5,200Estimated

Label	Type	Description	Intervention Names
Finerenone	Experimental		Drug: Finerenone
Placebo	Placebo Comparator		Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Finerenone	Drug	Oral finerenone	Finerenone	Kerendia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Composite of total HF events and cardiovascular (CV) death.	Total (first and subsequent) HF hospitalizations, urgent visits for worsening HF, and CV deaths with finerenone compared to placebo.	Ongoing, up to ~30 months
Number of serious adverse events.	Occurrence of serious adverse events (excluding efficacy endpoints) with finerenone compared to placebo.	Ongoing, up to ~30 months
Number of adverse events leading to discontinuation of study drug.	Occurrence of adverse events leading to study drug discontinuation with finerenone compared to placebo.	Ongoing, up to ~30 months

Secondary Outcomes

Measure	Description	Time Frame
Time to first occurrence of the composite of CV death or HF event.	Time to first occurrence of the composite of CV death or HF event with finerenone compared to placebo.	Ongoing, up to ~30 months
Total HF events.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Provide written informed consent
Age ≥18 years or legal age of majority if >18 years in the participant's country of residence
Current hospitalization or recently discharged (during or within 30 days of discharge) with the primary diagnosis of heart failure
Heart failure signs and symptoms at the time of hospital admission
Imaging evidence of mildly reduced or preserved left ventricular ejection fraction (EF) (40% or higher)
Elevated N-terminal pro B-type natriuretic peptide (NTproBNP) ≥500 pg/mL or B-type natriuretic peptide (BNP) ≥125 pg/mL for patients without atrial fibrillation (AF); or elevated NTproBNP ≥1500 pg/mL or BNP ≥375 pg/mL for patients with AF

Exclusion Criteria:

Current or planned long-term treatment with a mineralocorticoid receptor antagonist (MRA)
Documented prior history of severe hyperkalemia in the setting of MRA use
Estimated glomerular filtration rate (eGFR) <25 mL/min/1.73m² or potassium >5.0 mmol/L at screening
Acute myocardial infarction due to plaque rupture, coronary revascularization, valve replacement/repair, or implantation of a cardiac resynchronization therapy device within 30 days
Hemodynamically significant (severe) uncorrected primary cardiac valvular disease
Cardiomyopathy due to known acute inflammatory heart, infiltrative diseases, accumulation diseases, muscular dystrophies, cardiomyopathy with reversible causes, known hypertrophic obstructive cardiomyopathy, complex congenital heart disease, or known pericardial constriction
Probable alternative cause of participant's heart failure symptoms
Concomitant systemic therapy with potent cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors or moderate CYP3A4 inducers, or potent CYP3A4 inducers
Known hypersensitivity to the IP (active substance or excipients)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases