Health Condition 1: N184- Chronic kidney disease, stage 4 (severe) Health Condition 2: N185- Chronic kidney disease, stage 5 Health Condition 3: I504- Combined systolic (congestive) anddiastolic (congestive) heart failure
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of either sex aged between 18 and 80 years, 2. Mean sitting systolic blood pressure more than or equal to 110 mm Hg 3. Left ventricular ejection fraction less than or equal to 40% at baseline echocardiography. 4. NT-pro BNP levels more than 600 pg/mL.
Exclusion criteria
Exclusion criteria: 1. Patients with serum potassium more than 5.8 mmol/L at baseline 2. Patients with elevated SGOT, SGPT more than 2 times Upper Limit of Normal 3. Prior history of angioedema 4. Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To study the effect of Sacubitril /Valsartan on the rate of hospitalizations and symptoms during 6 months of treatment 2. To note the change in concentration of NT-pro BNP levels, proteinurea, eGFR and LVEF from baseline after 6 months of treatment.Timepoint: 12 months of Recruitment and 6 months of follow up | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To study the incidence of hyperkalaemia defined as serum potassium more than 6 meq/L during treatment with ARNI 2. To assess the decline in eGFR by more than 30% from baseline during treatment with ARNI Timepoint: 12 months of Recruitment and 6 months of follow up | — |
Countries
India
Contacts
CHRISTIAN MEDICAL COLLEGE AND HOSPITAL , LUDHIANA