A Study to Evaluate Finerenone on Clinical Efficacy and S... | NCT06033950

Studies
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

NCT06033950

Sponsor

Colorado Prevention Center

Status

Recruiting

Last Update Posted

Jul 10, 2026Actual

Enrollment

2,600Estimated

Phase

Phase 3

Conditions

Heart Failure

Interventions

Finerenone
Placebo

Countries

United States
Argentina
Brazil
Canada
Croatia
Czechia
Greece
Hungary
Italy
Japan
Poland
Spain
Sri Lanka
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

Aug 20, 2024Actual

Primary Completion Date

Aug 2026Estimated

Completion Date

Jan 2028Estimated

First Submitted Date

Aug 29, 2023

First Submission Date that Met QC Criteria

Sep 11, 2023

First Posted Date

Sep 13, 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 8, 2026

Last Update Posted Date

Jul 10, 2026Actual

Name	Class
St. Luke's Hospital, Kansas City, Missouri	OTHER
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma	INDUSTRY

Description Module

Brief Summary

Finerenone will be compared to placebo to determine efficacy and safety of treatment in patients with heart failure and reduced ejection fraction (HFrEF) who are intolerant or ineligible to receive treatment with steroidal mineralocorticoid receptor antagonists (sMRA).

Detailed Description

This is an international, randomized, double-blind, placebo-controlled trial of finerenone for the treatment of heart failure patients with reduced 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

2,600Estimated

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
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to first occurrence of cardiovascular (CV) death or HF event.	- Time to first CV death or HF event with finerenone compared to placebo.	Ongoing, up to ~30 months
Number of serious adverse events	- 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.	- Number of adverse events leading to discontinuation of investigational product with finerenone compared to placebo.	Ongoing, up to ~30 months

Secondary Outcomes

Measure	Description	Time Frame
Timing and occurrence of total CV deaths and HF events	- Timing and occurrence of total (first and subsequent) events of CV death and HF events and CV deaths with finerenone compared to placebo.	Ongoing, up to ~30 months
Timing and occurrence of total HF events

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Provide electronic or written informed consent, either personally or through a legally authorized representative, as permitted by local regulations
Age ≥18 years or legal age of majority if >18 years in the participant's country of residence
Symptomatic HFrEF per protocol defined criteria
Not on sMRA due to history of intolerance, contraindication, or ineligibility for treatment
Negative pregnancy test and agreement to use adequate contraception during trial (female participants only)

Exclusion Criteria:

Treatment with non-steroidal MRA (nsMRA)
Documented prior history of severe hyperkalemia in the setting of MRA use
eGFR < 25 mL/min/1.73m² and / or potassium > 5.0 mmol/L
Acute myocardial infarction, coronary revascularization, valve replacement/repair, or implantation of a cardiac resynchronization therapy device within 30 days or planned
Prior or planned heart transplant
Hemodynamically significant (severe) uncorrected primary cardiac valvular disease considered by the investigator to be the primary cause of heart failure
Symptomatic bradycardia or second- or third-degree heart block without a pacemaker
Cardiomyopathy due to known acute inflammatory heart disease, infiltrative diseases, accumulation diseases, muscular dystrophies, cardiomyopathy with reversible causes, hypertrophic obstructive cardiomyopathy, complex congenital heart disease, or pericardial constriction
Probable alternative cause of participant's HF
Concomitant systemic therapy with potent cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors, or moderate or potent CYP3A4 inducers
Known hypersensitivity to the IP (active substance or excipients)
Any other condition or therapy which would make the participant unsuitable for the study
Concurrent or previous participation in another interventional clinical study using an investigational agent within 30 days prior to randomization

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