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

Sponsor
Chongqing Medical University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05974566
Collaborator
(none)
60
Enrollment
3
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Efficacy and Safety of Finerenone in Patients With Heart Failure With Reduced Ejection Fraction
    Anticipated Study Start Date :
    Aug 1, 2023
    Anticipated Primary Completion Date :
    Sep 30, 2023
    Anticipated Study Completion Date :
    Oct 30, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Change in serum N-terminal pro-B-type natriuretic peptide (NT-proBNP) [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

    Secondary Outcome Measures

    1. Composite endpoint of death and heart failure rehospitalization [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

    2. Change in left ventricular ejection fraction (LVEF) [before and after 6 months of medication]

      The change in LVEF measured by echocardiogram

    3. Change in extracellular volume (ECV) [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

    4. Change in renal function level [Before and after 3 months of continuous treatment]

      Change in estimated glomerular filtration rate(eGFR) reflect the renal function

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Chongqing Medical University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dongying Zhang, Director, Chongqing Medical University
    ClinicalTrials.gov Identifier:
    NCT05974566
    Other Study ID Numbers:
    • 2023-07
    First Posted:
    Aug 3, 2023
    Last Update Posted:
    Aug 3, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Diabetic Nephropathies
    Heart Failure

    Study Results

    No Results Posted as of Aug 3, 2023