Health Condition 1: I502- Systolic (congestive) heart failure
Conditions
Interventions
Intervention1: Valsartan-Sacubitril (already approved by DCGI for heart failure): By oral route at 50 mg BD to 100 mg BD dose
Sponsors
NIL
Eligibility
Inclusion criteria
Inclusion criteria: Adult patients of 18 years of age and above and individuals of both genders diagnosed with heart failure (NYHA class II-IV) with ejection fraction less than 40 % irrespective of the etiology of heart failure and who give consent for participation in the study, shall be the study participants.
Exclusion criteria
Exclusion criteria: Patients of heart failure with a recent history of serious cardiovascular event such as myocardial infarction, stroke, or other thromboembolic event in last one month 2. Patients of heart failure with sepsis 3. Patients of heart failure with EF = 40% 4. Patients who refuse to participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the serum levels of endothelin-1, neuropeptide Y, and bradykininsTimepoint: at baseline, 4 weeks, 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| • Improvement in 2-D Echo markers like Left ventricle ejection fraction (LVEF), left ventricle end diastolic volume index (LVEDVI), left ventricle end systolic volume index (LVESVI), at 1-month, 6 month and 12 month compared to baseline. • Levels of BNP and NT-Pro BNP at baseline, 1 month and 6 month • Hospitalisations due to heart failure and time to hospitalisation due to heart failure since the onset of therapy over 18 months of follow up. • Death due to cardiovascular cause and time to occurrence of death since the onset of therapy over 18 months of follow up. • Death due to any cause and time to occurrence of death since the onset of therapy over 18 months of follow up. Timepoint: 0, 1 month, 6 month, 12 month, 18 month | — |
Countries
India
Contacts
Public ContactUpinder Kaur
IMS BHU
Outcome results
None listed