Heart Failure study: Finerenone
Official title 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
ClinicalTrials.gov ID: NCT06033950
What this study is testing
What is Finerenone?
Finerenone is an investigational oral medicine being studied as a potential treatment for heart failure with reduced ejection fraction. Finerenone is designed to block the mineralocorticoid receptor, reducing harmful effects of excess aldosterone in the heart and kidneys.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find out if finerenone works well and is safe for people with heart failure who cannot use other specific heart medications.
- Who it's for
- The study is looking for people with heart failure who have a weak heart pump and cannot take standard steroid-based heart medicines.
- What's involved
- Participants will take either finerenone or a placebo (a pill with no active medicine) and undergo regular health checks to monitor their condition.
- Time commitment
- The source text does not specify the total duration of the study or the exact number of visits required.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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)
You likely can't join if
- Treatment with non-steroidal MRA (nsMRA)
- Documented prior history of severe hyperkalemia in the setting of MRA use
- eGFR \ 5.0 mmol/L
- Acute myocardial infarction, coronary revascularization, valve replacement/repair, or implantation of a cardiac resynchronization therapy device...
- Prior or planned heart transplant
- Hemodynamically significant (severe) uncorrected primary cardiac valvular disease considered by the investigator to be the primary cause of heart...
See the full eligibility 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)
- Treatment with non-steroidal MRA (nsMRA)
- Documented prior history of severe hyperkalemia in the setting of MRA use
- eGFR \ 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...
- 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 treatment clinical study using an investigational agent within 30 days prior to randomization
The study team makes the final eligibility decision.
Where it is enrolling
- Fairhope, Alabama, United States
- Phoenix, Arizona, United States
- Yuma, Arizona, United States
- Chula Vista, California, United States
- Northridge, California, United States
- Orange, California, United States
- Pomona, California, United States
- Sacramento, California, United States
- San Diego, California, United States
- San Francisco, California, United States
- Sherman Oaks, California, United States
- Tarzana, California, United States
- Van Nuys, California, United States
- West Covina, California, United States
- West Hills, California, United States
- Aurora, Colorado, United States
- Bradenton, Florida, United States
- Hialeah, Florida, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
+ 128 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Fairhope, Alabama, United States; Phoenix, Arizona, United States; Yuma, Arizona, United States; Chula Vista, California, United States; Northridge, California, United States; Orange, California, United States and 142 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.