Heart Failure Clinical Trial
— FINALITY-HFOfficial title:
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)
Finerenone will be compared to placebo to determine efficacy and safety of treatment in patients heart failure and reduced ejection fraction (HFrEF) who are intolerant or ineligible to receive treatment with steroidal mineralocorticoid receptor antagonist (sMRA).
Status | Not yet recruiting |
Enrollment | 2600 |
Est. completion date | January 2028 |
Est. primary completion date | August 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Provide electronic or written informed consent, either personally or through a legally authorized representative - Age =18 years or legal age of majority - 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) - eGFR < 25 mL/min/1.73m² and / or serum/plasma potassium > 5.0 mmol/L - Type 1 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 - Any other condition or therapy which would make the participant unsuitable for the study - Concurrent participation in another interventional clinical study using an investigational agent |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Colorado Prevention Center | Bayer, Saint Luke's Hospital of Kansas City |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | Number of serious adverse events | - Serious adverse events (excluding efficacy endpoints) with finerenone compared to placebo. | Ongoing, up to ~30 months | |
Primary | 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 | Timing and occurrence of total HF events and CV deaths. | - Timing and occurrence of total (first and subsequent) HF events and CV deaths with finerenone compared to placebo. | Ongoing, up to ~30 months | |
Secondary | Change in Total Symptom Score on the Kansas City Cardiomyopathy Questionnaire (KCCQ-TSS) at Day 180. | - Change in KCCQ-TSS with finerenone compared to placebo. | 180 days | |
Secondary | Time to first occurrence of composite kidney endpoint. | Composite endpoint: Estimated glomerular filtration rate (eGFR) =50% relative to baseline over at least 4 weeks, or sustained eGFR decline to <15 ml/min/1.73 m2 or the initiation of long-term dialysis or kidney transplantation with finerenone compared to placebo. |
Ongoing, up to ~30 months | |
Secondary | Time to CV death. | - Time to CV death with finerenone compared to placebo. | Ongoing, up to ~30 months | |
Secondary | Time to death from any cause. | - Time to all-cause mortality with finerenone compared to placebo. | Ongoing, up to ~30 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05650307 -
CV Imaging of Metabolic Interventions
|
||
Recruiting |
NCT05654272 -
Development of CIRC Technologies
|
||
Recruiting |
NCT05196659 -
Collaborative Quality Improvement (C-QIP) Study
|
N/A | |
Active, not recruiting |
NCT05896904 -
Clinical Comparison of Patients With Transthyretin Cardiac Amyloidosis and Patients With Heart Failure With Reduced Ejection Fraction
|
N/A | |
Completed |
NCT05077293 -
Building Electronic Tools To Enhance and Reinforce Cardiovascular Recommendations - Heart Failure
|
||
Recruiting |
NCT05631275 -
The Role of Bioimpedance Analysis in Patients With Chronic Heart Failure and Systolic Ventricular Dysfunction
|
||
Enrolling by invitation |
NCT05564572 -
Randomized Implementation of Routine Patient-Reported Health Status Assessment Among Heart Failure Patients in Stanford Cardiology
|
N/A | |
Enrolling by invitation |
NCT05009706 -
Self-care in Older Frail Persons With Heart Failure Intervention
|
N/A | |
Recruiting |
NCT04177199 -
What is the Workload Burden Associated With Using the Triage HF+ Care Pathway?
|
||
Terminated |
NCT03615469 -
Building Strength Through Rehabilitation for Heart Failure Patients (BISTRO-STUDY)
|
N/A | |
Recruiting |
NCT06340048 -
Epicardial Injection of hiPSC-CMs to Treat Severe Chronic Ischemic Heart Failure
|
Phase 1/Phase 2 | |
Recruiting |
NCT05679713 -
Next-generation, Integrative, and Personalized Risk Assessment to Prevent Recurrent Heart Failure Events: the ORACLE Study
|
||
Completed |
NCT04254328 -
The Effectiveness of Nintendo Wii Fit and Inspiratory Muscle Training in Older Patients With Heart Failure
|
N/A | |
Completed |
NCT03549169 -
Decision Making for the Management the Symptoms in Adults of Heart Failure
|
N/A | |
Recruiting |
NCT05572814 -
Transform: Teaching, Technology, and Teams
|
N/A | |
Enrolling by invitation |
NCT05538611 -
Effect Evaluation of Chain Quality Control Management on Patients With Heart Failure
|
||
Recruiting |
NCT04262830 -
Cancer Therapy Effects on the Heart
|
||
Completed |
NCT06026683 -
Conduction System Stimulation to Avoid Left Ventricle Dysfunction
|
N/A | |
Withdrawn |
NCT03091998 -
Subcu Administration of CD-NP in Heart Failure Patients With Left Ventricular Assist Device Support
|
Phase 1 | |
Recruiting |
NCT05564689 -
Absolute Coronary Flow in Patients With Heart Failure With Reduced Ejection Fraction and Left Bundle Branch Block With Cardiac Resynchronization Therapy
|