A clinical study to assess safety and efficacy of finerenone in patients of Heart Failure and with preserved ejection fraction.
- Conditions
- Heart failure, unspecified,
- Registration Number
- CTRI/2021/03/032071
- Lead Sponsor
- Bayer Pharmaceuticals Private Limited
- Brief Summary
The purpose of this study is to evaluate the effect of finerenone compared to placebo (a tablet without active substance) in the reduction of cardiovascular death (generally meaning death due to disease of the heart or blood vessels) and total Heart Failure (HF) events, including HF hospitalization and urgent visits for HF(generally meaning a hospital stay or urgent presentation to a healthcare unit due to worsening symptoms of heart failure) in patients suffering from HF with an ejection fraction greater than or equal to 40%. Researchers will also collect information on how much the heart disease has impact on patient’s lives, change of kidney function, and how well finerenone treatment is tolerated. The study plans to enroll 5500 male and female patients of the age of 40 years and above suffering from heart failure with ejection fraction greater than or equal to 40%. Participants will take the study product as oral tablet with a dose between 0 (Placebo) 40 mg once daily. Study duration will be up to 43 months.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 5500
- 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 prior to randomization.
- 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) more than or equal to 3.8cm left atrial area (LAA) more than or equal to 20cm2 left atrial volume index (LAVI) more than 30 mL/m2 left ventricular mass index (LVMI) more than or equal to 115 g/m2 (male)/ 95 g/m2 (Female) septal thickness or posterior wall thickness more than or equal to 1.1 cm 6 n-terminal prohormone B-type natriuretic peptide (NT-proBNP) more than or equal to 300 pg/mL B-type natriuretic peptide (BNP more than or equal to 100 pg/mL) in SR or NT-proBNP more than or equal to 900pg/mL (BNP more than or equal to 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 a pregnancy test is negative at screening and baseline and if they agree to use adequate contraception which is consistent with local regulations regarding the methods for contraception for those participating in clinical trials.
- 1 Estimated glomerular filtration rate (eGFR) less than 25 mL/min/1.73 m² at either screening or randomization visit 2 Serum/plasma potassium more than 5.0 mmol/L at either screening or randomization visit 3 Acute inflammatory heart disease, e.g. acute myocarditis, within 90 days prior to randomization 4 Myocardial infarction or any event which could have reduced the ejection fraction within 90 days prior to randomization 5 Coronary artery bypass graft surgery in the 90 days prior to randomization 6 Percutaneous coronary intervention in the 30 days prior to randomization 7 Stroke or transient ischemic cerebral attack within 90 days prior to randomization 8 Probable alternative cause of participants’ HF symptoms that in the opinion of the investigator primarily accounts for patient’s dyspnea such as significant pulmonary disease, anemia or obesity.
- Specifically, patients with the below are excluded: Severe pulmonary disease requiring home oxygen, or chronic oral steroid therapy, History of primary pulmonary arterial hypertension, Hemoglobin less than 10 g/dl, Valvular heart disease considered by the investigator to be clinically significant, Body Mass Index (BMI) more than 50 kg/m2 at screening 9 Systolic blood pressure(SBP) more than or equal to 160 mmHg if not on treatment with ≥3 blood pressure lowering medications or more than or equal to 180 mmHg irrespective of treatments, on 2 consecutive measurements at least 2-minute apart, at screening or at randomization.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Composite CV endpoints: 3.5 years CV death 3.5 years Hospitalization due to HF (Heart Failure) 3.5 years Urgent HF visits 3.5 years
- Secondary Outcome Measures
Name Time Method Total Symptom Score (TSS) 6 Months, 9 months and 12 Months from baseline. All-cause mortality 3.5 years Sustained decrease in estimated glomerular filtration rate more than or equal to 40 percent relative to baseline over at least 4 weeks. or
Trial Locations
- Locations (7)
Deenanath Mangeshkar Hospital and Research Center
🇮🇳Pune, MAHARASHTRA, India
Healthworld Hospitals
🇮🇳Barddhaman, WEST BENGAL, India
KEM Hospital
🇮🇳Pune, MAHARASHTRA, India
Lokmanya Tilak Municipal Medical College and Lokmanya Tilak Municipal General Hospital
🇮🇳Mumbai, MAHARASHTRA, India
Max Super Specialty Hospital
🇮🇳South, DELHI, India
The Madras Medical Mission
🇮🇳Chennai, TAMIL NADU, India
Vardhman Mahavir Medical College and Safdarjung Hospital
🇮🇳Delhi, DELHI, India
Deenanath Mangeshkar Hospital and Research Center🇮🇳Pune, MAHARASHTRA, IndiaDr Shireesh SathePrincipal investigator9822053216shireesh.sathe@gmail.com