Diabetes Mellitus, Diabetic Nephropathies, Heart Failure With Reduced Ejection Fraction
Conditions
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.
Interventions
None listed
Sponsors
Chongqing Medical University
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Change in left ventricular ejection fraction (LVEF) | before and after 6 months of medication | The change in LVEF measured by echocardiogram |
| 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 |
| Change in renal function level | Before and after 3 months of continuous treatment | Change in estimated glomerular filtration rate(eGFR) reflect the renal function |
Contacts
Primary ContactDongying Zhang, PhD
Outcome results
None listed