Efficacy and Safety of Finerenone in Heart Failure With Reduced Ejection Fraction

July 26, 2023 updated by: Dongying Zhang, Chongqing Medical University

Efficacy and Safety of Finerenone in Patients With Heart Failure With Reduced Ejection Fraction

Finerenone is a new selective nonsteroidal mineral corticoid receptor antagonist (MRA), nowadays it's widely used in type 2 diabetes (T2DM) patients with chronic kidney disease (CKD), the newest trial shows finerenone improve the cardiovascular outcomes among patients with T2DM and CKD especially reduce the risk of hospitalization for heart failure. In patients with diabetic nephropathy, finerenone resulted in lower risks of CKD progression and cardiovascular events. Finerenone shows great potential therapeutic effect in chronic heart failure (CHF) patients with or without T2DM and CKD compared to eplerenone, but there is still no real world study on finerenone in patients with heart failure with reduced ejection fraction (HFrEF) and it's unclear about the effect of finerenone in CHF patients without T2DM and CKD. The investigators will conduct a study to demonstrate the efficacy and safety of finerenone in HFrEF patients compared to other MRAs.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Dongying Zhang, PhD
  • Phone Number: +86-13608398395
  • Email: zdy.chris@qq.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with heart failure with reduced ejection fraction and NYHA classes II-IV with or without diabetic nephropathy will be incorporated in the study, and other patients who are unable to tolerant treatment will be excluded

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • New York Heart Association(NYHA) functional classification II - IV
  • LVEF measured by the echocardiogram ≤ 45%
  • eGFR>25mL/min/1.73m²

Exclusion Criteria:

  • LVEF measured by the echocardiogram > 45%
  • History of allergic or hypersensitivity to drugs involved in the trial.
  • Patients with a known history of cancer, angioedema, significant congenital heart disease or rheumatic heart disease.
  • Patients diagnosed with myocarditis.
  • Probable alternative diagnoses could account for the patient's HF symptoms e.g., COPD, bronchial asthma, primary pulmonary hypertension.

  • Systolic blood pressure (SBP) ≥180mmHg or diastolic blood pressure (DBP)

    • 120mmHg at visit, DBP≤90mmHg or symptomatic hypotension.
  • Patients with cardiac pacemaker
  • Pregnant woman
  • eGFR≤25mL/min/1.73m² and not accept long-term hemodialysis therapy.
  • Serum potassium >5.2 mmol/l at visit
  • Fatal or uncontrollable heart arrythmia e.g., symptomatic or persistence ventricular tachycardia, ventricular rate>150 bpm in AF patients.
  • Obvious stenosis (≥50%) of bilateral renal arteries.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
HFrEF patients who accept finerenone therapy
Patients with HFrEF receive finerenone 10mg or 20mg daily treatment for 3 months in addition to other medications.
HFrEF patients who accept Spironolactone or eplerenone therapy
Patients with HFrEF receive spironolactone or eplerenone treatment daily treatment for 3 months in addition to other medications.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in serum N-terminal pro-B-type natriuretic peptide (NT-proBNP)
Time Frame: before and after 6 months of medication
The change in serum NT-proBNP levels in patients was measured before medication and after 6 months of medication to determine the improvement on heart failure
before and after 6 months of medication

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite endpoint of death and heart failure rehospitalization
Time Frame: during the 6-month period of medication therapy
The composite endpoint include the death due to cardiovascular reasons, worsening of renal disease, rehospitalization due to heart failure and admission to hospital to accept intravenous diuretics therapy
during the 6-month period of medication therapy
Change in left ventricular ejection fraction (LVEF)
Time Frame: before and after 6 months of medication
The change in LVEF measured by echocardiogram
before and after 6 months of medication
Change in extracellular volume (ECV)
Time Frame: Before and after 3 months of continuous treatment
Extracellular volume (ECV) measured by cardiac magnetic resonance imaging (CMR) helps to demonstrate the improvement in myocardial fibrosis
Before and after 3 months of continuous treatment
Change in renal function level
Time Frame: Before and after 3 months of continuous treatment
Change in estimated glomerular filtration rate(eGFR) reflect the renal function
Before and after 3 months of continuous treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chongqing Medical University

Investigators

  • Study Chair: Dongying Zhang, PhD, First Affiliated Hospital of Chongqing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2023

Primary Completion (Estimated)

September 30, 2023

Study Completion (Estimated)

October 30, 2023

Study Registration Dates

First Submitted

July 16, 2023

First Submitted That Met QC Criteria

July 26, 2023

First Posted (Actual)

August 3, 2023

Study Record Updates

Last Update Posted (Actual)

August 3, 2023

Last Update Submitted That Met QC Criteria

July 26, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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