Clinical trial NCT05974566: Efficacy and Safety of Finerenone in Heart Failure With Reduced Ejection Fraction
Official title: Efficacy and Safety of Finerenone in Patients With Heart Failure With Reduced Ejection Fraction
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Heart Failure With Reduced Ejection Fraction
Diabetes Mellitus
Diabetic Nephropathies
Lead sponsor: Chongqing Medical University
Sponsor class: OTHER
First posted: 2023-08-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in serum N-terminal pro-B-type natriuretic peptide (NT-proBNP)
timeFrame: before and after 6 months of medication
Secondary outcomes:
measure: Composite endpoint of death and heart failure rehospitalization
timeFrame: during the 6-month period of medication therapy
measure: Change in left ventricular ejection fraction (LVEF)
timeFrame: before and after 6 months of medication
measure: Change in extracellular volume (ECV)
timeFrame: Before and after 3 months of continuous treatment
measure: Change in renal function level
timeFrame: Before and after 3 months of continuous treatment
Other outcomes:
Locations:
Study officials:
affiliation: First Affiliated Hospital of Chongqing Medical University
name: Dongying Zhang, PhD
role: STUDY_CHAIR
References:
citation: Pitt B, Filippatos G, Agarwal R, Anker SD, Bakris GL, Rossing P, Joseph A, Kolkhof P, Nowack C, Schloemer P, Ruilope LM; FIGARO-DKD Investigators. Cardiovascular Events with Finerenone in Kidney Disease and Type 2 Diabetes. N Engl J Med. 2021 Dec 9;385(24):2252-2263. doi: 10.1056/NEJMoa2110956. Epub 2021 Aug 28.
citation: Bakris GL, Agarwal R, Anker SD, Pitt B, Ruilope LM, Rossing P, Kolkhof P, Nowack C, Schloemer P, Joseph A, Filippatos G; FIDELIO-DKD Investigators. Effect of Finerenone on Chronic Kidney Disease Outcomes in Type 2 Diabetes. N Engl J Med. 2020 Dec 3;383(23):2219-2229. doi: 10.1056/NEJMoa2025845. Epub 2020 Oct 23.
citation: Filippatos G, Anker SD, Bohm M, Gheorghiade M, Kober L, Krum H, Maggioni AP, Ponikowski P, Voors AA, Zannad F, Kim SY, Nowack C, Palombo G, Kolkhof P, Kimmeskamp-Kirschbaum N, Pieper A, Pitt B. A randomized controlled study of finerenone vs. eplerenone in patients with worsening chronic heart failure and diabetes mellitus and/or chronic kidney disease. Eur Heart J. 2016 Jul 14;37(27):2105-14. doi: 10.1093/eurheartj/ehw132. Epub 2016 Apr 29.