NCT06033950 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
| NCT ID | NCT06033950 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Colorado Prevention Center |
| Condition | Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,600 participants |
| Start Date | 2024-08-20 |
| Primary Completion | 2028-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 2,600 participants in total. It began in 2024-08-20 with a primary completion date of 2028-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06033950 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06033950 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 2,600 participants.
Is NCT06033950 currently recruiting?
Yes, NCT06033950 is actively recruiting participants. Contact the research team at info@cpcmed.org for enrollment information.
Where is the NCT06033950 trial being conducted?
This trial is being conducted at Fairhope, United States, San Diego, United States, Kansas City, United States, Austin, United States and 4 additional locations.
Who is sponsoring the NCT06033950 clinical trial?
NCT06033950 is sponsored by Colorado Prevention Center. The trial plans to enroll 2,600 participants.
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