A clinical study to assess safety and efficacy of finerenone in patients of Heart Failure and with preserved ejection fraction.
- Conditions
- Health Condition 1: I509- Heart failure, unspecified
- Registration Number
- CTRI/2021/03/032071
- Lead Sponsor
- Bayer Pharmaceuticals Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1 Participant (male or female) must be aged 40 years and older.
2 Diagnosis of heart failure with New York Heart Association(NYHA) class IIâ??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 participantsâ?? HF symptoms that in the opinion of the investigator primarily accounts for
patientâ??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: <br/ ><br>CV death <br/ ><br>Hospitalization due to HF (Heart Failure) <br/ ><br>Urgent HF visitsTimepoint: 3.5 years
- Secondary Outcome Measures
Name Time Method All-cause mortalityTimepoint: 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. <br/ ><br> <br/ ><br>or <br/ ><br> <br/ ><br>Sustained eGFR decline less than 15 ml per min <br/ ><br> <br/ ><br>or <br/ ><br> <br/ ><br>Initiation of dialysis or renal transplantation.Timepoint: 3.5 years;Total Symptom Score (TSS)Timepoint: 6 Months, 9 months and 12 Months from baseline.