Health Condition 1: I503- Diastolic (congestive) heart failure
Conditions
Interventions
Intervention1: Sacubitril/Valsartan with Standard Therapy: Standard Therapy with Tab.Sacubitril/Valsartan 50mg twice daily will be given for the duration of 12 weeks. The enrolled patients will be ass
Sponsors
Pt B.D. Sharma UHS Rohtak
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -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
| Measure | Time frame |
|---|---|
| -Change in high-sensitivity C-reactive protein levels 12 weeks from baseline in patients with heart failure with mildly reduced or preserved ejection fraction. -The proportion of patients exhibiting any alteration in NYHA heart failure class 12 weeks from baseline in patients with heart failure with mildly reduced or preserved ejection fraction. -Changes in tissue doppler indices of diastolic dysfunction (ratio of mitral inflow velocity to annular relaxation velocity i.e. E/E’ ratio, E’/Absolute value, E/A ratio) 12 weeks from baseline in patients with heart failure with mildly reduced or preserved ejection fraction. -Alteration in the World Health Organisation Quality of Life Questionnaire (WHOQOL-BREF) score 12 weeks from baseline in patients with heart failure with mildly reduced or preserved ejection fraction. -Incidence of study drug withdrawals due to treatment-related adverse events or worsening heart failure -Incidence of mortality from cardiovascular causes. Timepoint: Baseline & 12 weeks. | — |
Countries
India
Contacts
Public ContactDr Reevanshi Dhawan
Pt B.D. Sharma PGIMS Rohtak
Outcome results
None listed