To assess the effectiveness and safety of adding sacubitril/valsartan to the standard treatment for the heart failure patients
Phase 4
- Conditions
- Health Condition 1: I503- Diastolic (congestive) heart failure
- Registration Number
- CTRI/2023/07/055325
- Lead Sponsor
- Pt B.D. Sharma UHS Rohtak
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Presence of New York Heart Association functional class II–III
-Echocardiographic evidence of LV diastolic dysfunction/systolic dysfunction
-Willing to give written informed consent
Exclusion Criteria
-Clinically unstable patient as defined by any change in diuretic dose in the month before enrollment
-Significant valvular heart disease, pericardial disease, hypertrophic or restrictive cardiomyopathy
-Unstable angina or MI within the past 4 weeks
-Alternative probable cause of patient’s symptoms (e.g. significant pulmonary disease)
-Pregnant or lactating females
-Currently on ACEI/ARB/ARNi/NSAIDS/Steroids
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method -Change in N-terminal pro-b-type natriuretic peptide levels at 12 weeks from baseline in patients with heart failure with mildly reduced or preserved ejection fraction.Timepoint: -Change in N-terminal pro-b-type natriuretic peptide levels at 12 weeks from baseline in patients with heart failure with mildly reduced or preserved ejection fraction.
- Secondary Outcome Measures
Name Time Method