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Looking for participantsPhase3

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

Sponsor: Colorado Prevention Center

NCT ID: NCT06008197

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Finerenone (drug), Placebo (drug)
How long the study runs
Study runs about 47 months (dates as stated)
About the drug or intervention
Finerenone — drug: Oral finerenone · Placebo — drug: Matching oral placebo
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
5,200
Started
2024-01-17
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for heart failure
  • • Phase3 - 5,200 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with heart failure

Where?

  • • Brighton - Brighton, East Sussex Investigative Site 39021
  • • Southampton - Southampton, Hampshire Investigative Site 39006
  • • Ashford - Ashford, Kent Investigative Site 39020
  • • Liverpool - Liverpool, Liverpool Investigative Site 39024
  • • +14 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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.

Heart FailureAcute Heart Failure

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

eGFR

What the study is looking for

  • ✓Provide written agreement to take part
  • ✓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 signs and symptoms at the time of hospital admission
  • ✓Imaging evidence of mildly reduced or preserved left ventricular ejection fraction (EF) (40% or higher)

Who cannot take part

  • ✗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...
  • ✗Hemodynamically significant (severe) uncorrected primary heart valvular disease
See the full 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)

Where Is This Study? (18 UK sites)

Brighton, East Sussex Investigative Site 39021

Brighton BN2 1ES, United Kingdom

Recruiting
Site contact (verified)

Southampton, Hampshire Investigative Site 39006

Southampton SO16 6YD, United Kingdom

Recruiting
Site contact (verified)

Ashford, Kent Investigative Site 39020

Ashford TN02 0LZ, United Kingdom

Recruiting
Site contact (verified)

Liverpool, Liverpool Investigative Site 39024

Liverpool L9 7AL, United Kingdom

Recruiting
Site contact (verified)

Chester, North West England Investigative Site 39022

Chester CH2 1UL, United Kingdom

Recruiting
Site contact (verified)

Ashington, Northumberland Investigative Site 39017

Ashington NE63 9JJ, United Kingdom

Recruiting
Site contact (verified)

Dudley, West Midlands Investigative Site 39018

Dudley DY1 2HQ, United Kingdom

Recruiting
Site contact (verified)

Cardiff, Investigative Site 39015

Cardiff CF14 4XW, United Kingdom

Recruiting
Site contact (verified)

Darlington Investigative Site 39025

Darlington DL3 6HX, United Kingdom

Recruiting
Site contact (verified)

Durham Investigative Site 39026

Durham DH1 5TW, United Kingdom

Recruiting
Site contact (verified)

Glasgow Investigative Site 39001

Glasgow G4 0SF, United Kingdom

Recruiting
Site contact (verified)

Leeds, Investigative Site 39023

Leeds LS1 3EX, United Kingdom

Recruiting
Site contact (verified)

London, Investigative Site 39016

London SE5 9RS, United Kingdom

Recruiting
Site contact (verified)

London, Investigative Site 39002

London SW17 0QT, United Kingdom

Recruiting
Site contact (verified)

Manchester Investigative Site 39003

Manchester M13 9WL, United Kingdom

Recruiting
Site contact (verified)

Plymouth, Investigative Site 39014

Plymouth PL6 8DH, United Kingdom

Recruiting
Site contact (verified)

Portadown, Investigative Site 39005

Portadown BT63 5QQ, United Kingdom

Recruiting
Site contact (verified)

Swindon Investigative Site 39004

Swindon SN3 6BB, United Kingdom

Recruiting
Site contact (verified)

How to Get in Touch

Marc Bonaca

Sponsor contact

CONTACT

303-860-9900 info@cpcmed.org
Data sourced from ClinicalTrials.gov · Last verified: 2026-09