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Mineralocorticoid Receptor Antagonist

Finerenone for Heart Failure (REDEFINE-HF Trial)

Q: Is the enrollment for participants in this study currently ongoing?

Indeed, as per the information available on clinicaltrials.gov, this study is currently seeking eligible participants. The trial was initially posted on January 1st, 2024 and last updated on January 3rd, 2024.

Q: What is the current number of individuals participating in this research endeavor?

Indeed, the information provided on clinicaltrials.gov indicates that this ongoing study is actively seeking eligible participants. The trial's initial posting was on January 1st, 2024 and it was most recently updated on January 3rd, 2024. A total of 5200 patients are needed to participate in this research project across two designated sites.

Q: What is the level of safety associated with Finerenone when used by individuals?

Based on the classification of this trial as Phase 3, indicating existing data supporting both efficacy and safety, our team at Power rates the safety profile of Finerenone as a 3.

Phase 3

Recruiting

Research Sponsored by Colorado Prevention Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Current hospitalization or recently discharged with the primary diagnosis of heart failure

Heart failure signs and symptoms at the time of hospital admission

Timeline

Screening 3 weeks

Treatment Varies

Follow Up ongoing, up to ~30 months

Awards & highlights

REDEFINE-HF Trial Summary

This trial will compare finerenone to a fake treatment (placebo) to see if it works and is safe for patients with a specific type of heart failure.

Who is the study for?

This trial is for adults over 18 with heart failure who are currently hospitalized or recently discharged. They must have a left ventricular ejection fraction of 40% or higher and show specific signs, symptoms, and elevated levels of certain heart-related biomarkers.Check my eligibility

What is being tested?

The study tests the effectiveness and safety of Finerenone compared to a placebo in patients with acute decompensated heart failure and mildly reduced or preserved heart function.See study design

What are the potential side effects?

While not specified here, common side effects of Finerenone may include high potassium levels, changes in kidney function, low blood pressure, dizziness, and potential allergic reactions.

REDEFINE-HF Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I was recently in the hospital for heart failure.

Select...

I was admitted to the hospital with heart failure symptoms.

Select...

I am 18 years old or older.

REDEFINE-HF Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ ongoing, up to ~30 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~ongoing, up to ~30 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and ongoing, up to ~30 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Composite total of HF events and cardiovascular (CV) death.

Number of adverse events leading to discontinuation of study drug.

Number of serious adverse events.

Secondary outcome measures

Change from baseline in the Total Symptom Score on the Kansas City Cardiomyopathy Questionnaire (KCCQ-TSS) at Month 6.

Time to CV death.

Time to death from any cause.

+2 more

Other outcome measures

Number of patients requiring initiation of dialysis or renal transplant.

Number of patients with sustained decrease in eGFR ≥40% relative to baseline.

Number of patients with sustained eGFR <15 ml/min/1.73 m^2.

+2 more

REDEFINE-HF Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: FinerenoneExperimental Treatment1 Intervention

Group II: PlaceboPlacebo Group1 Intervention

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Colorado Prevention CenterLead Sponsor

12 Previous Clinical Trials

17,434 Total Patients Enrolled

3 Trials studying Heart Failure

4,151 Patients Enrolled for Heart Failure

Saint Luke's Hospital of Kansas CityUNKNOWN

3 Previous Clinical Trials

5,350 Total Patients Enrolled

2 Trials studying Heart Failure

4,100 Patients Enrolled for Heart Failure

BayerIndustry Sponsor

2,240 Previous Clinical Trials

25,327,577 Total Patients Enrolled

47 Trials studying Heart Failure

57,049 Patients Enrolled for Heart Failure

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment for participants in this study currently ongoing?

"Indeed, as per the information available on clinicaltrials.gov, this study is currently seeking eligible participants. The trial was initially posted on January 1st, 2024 and last updated on January 3rd, 2024."

Answered by AI

What is the current number of individuals participating in this research endeavor?

"Indeed, the information provided on clinicaltrials.gov indicates that this ongoing study is actively seeking eligible participants. The trial's initial posting was on January 1st, 2024 and it was most recently updated on January 3rd, 2024. A total of 5200 patients are needed to participate in this research project across two designated sites."

Answered by AI

What is the level of safety associated with Finerenone when used by individuals?

"Based on the classification of this trial as Phase 3, indicating existing data supporting both efficacy and safety, our team at Power rates the safety profile of Finerenone as a 3."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "A Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06008197.