Study to Evaluate the Efficacy and Safety of Finerenone on Morbidity & Mortality in Participants With Heart Failure with Preserved Ejection Fraction (HFpEF) (FINEARTS-HF)

In by ECIR

Locations
St. Augustine
Condition
Heart Failure

Study to Evaluate the Efficacy and Safety of Finerenone on Morbidity & Mortality in Participants With Heart Failure with Preserved Ejection Fraction (HFpEF) (FINEARTS-HF)

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A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Finerenone on Morbidity and Mortality in Participants With Heart Failure (NYHA II-IV) and Left Ventricular Ejection Fraction ≥ 40% (LVEF ≥ 40%)

clinicaltrials.gov

Eligibility

Inclusion Criteria
  1. Participant (male or female) must be aged 40 years and older.
  2. Diagnosis of heart failure with New York Heart Association(NYHA) class II-IV, ambulatory or hospitalized primarily for heart failure.
  3. On diuretic treatment for at least 30 days
  4. Documented left ventricular ejection fraction (LVEF) of ≥40% measured by any modality within the last 12 months.
  5. Structural heart abnormalities based on any local imaging measurement within the last 12 months, defined by at least one of the following findings: left atrial diameter (LAD) ≥3.8cm, left atrial area (LAA) ≥20cm2, left atrial volume index (LAVI) >30 mL/m2, left ventricular mass index (LVMI) ≥115 g/m2 (♂)/ 95 g/m2 (♀), septal thickness or posterior wall thickness ≥1.1 cm
  6. n-terminal prohormone B-type natriuretic peptide(NT-proBNP) ≥300 pg/mL B-type natriuretic peptide (BNP ≥ 100 pg/mL) in SR or NT-proBNP ≥900pg/mL (BNP ≥ 300 pg/mL) in atrial fibrillation (AF) obtained at the following time:
    • Within 90 days prior to randomization if patient had been hospitalized for heart failure (HF) requiring initiation or change in HF therapy or if patient had an urgent visit for HF requiring intravenous (IV) diuretic therapy, both within 90 days prior to randomization OR
    • Within 30 days prior to randomization if patient has not been hospitalized for HF nor had an urgent HF visit within the past 90 days.
  7. Women of childbearing potential can only be included in the study if they agree to use adequate contraception which is consistent with local regulations regarding the methods for contraception for those participating in clinical trials.
Exclusion Criteria
  1. GFR <25 ml/min/1.73 m²
  2. Serum/plasma potassium >5.0 mmol/L
  3. Acute inflammatory heart disease, e.g. acute myocarditis, within 90 days
  4. Myocardial infarction or any event which could have reduced the ejection fraction within 90 days
  5. Coronary artery bypass graft surgery within 90 days
  6. Percutaneous coronary intervention within 30 days
  7. Stroke or transient ischemic cerebral attack within 90 days
  8. Severe pulmonary disease requiring home oxygen, or chronic oral steroid therapy, History of primary pulmonary arterial hypertension, Hemoglobin <10 g/dl, Valvular heart disease, Body Mass Index (BMI) >50 kg/m2 at screening
  9. Systolic blood pressure(SBP) ≥160 mmHg if not on treatment with ≥3 blood pressure lowering medications or ≥180 mmHg irrespective of treatments.
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