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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05974566
• Other study ID #: 2023-07
• Status: Not yet recruiting
• Start date: August 1, 2023
• Est. completion date: October 30, 2023

Study information

• Verified date: July 2023
• Source: Chongqing Medical University
• Contact: Dongying Zhang, PhD
• Phone: +86-13608398395
• Email: zdy.chris[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: October 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetic Nephropathies
• Heart Failure
• Heart Failure With Reduced Ejection Fraction

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chongqing Medical University

References & Publications (3)

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 — View 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 — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in serum N-terminal pro-B-type natriuretic peptide (NT-proBNP)	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	Composite endpoint of death and heart failure rehospitalization	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
Secondary	Change in left ventricular ejection fraction (LVEF)	The change in LVEF measured by echocardiogram	before and after 6 months of medication
Secondary	Change in extracellular volume (ECV)	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
Secondary	Change in renal function level	Change in estimated glomerular filtration rate(eGFR) reflect the renal function	Before and after 3 months of continuous treatment