Cardiac outcomes with addition of Sacubitril-Valsartan in dialysis patients with heart failure â?? a pilot study
Phase 3
- Conditions
- Health Condition 1: N186- End stage renal disease
- Registration Number
- CTRI/2023/01/048730
- Lead Sponsor
- IQRAA Hospital, Calicut
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Chronic kidney disease stage 5, on maintanence dialysis
-Systolic dysfunction with EF <= 40% or diastolic dysfunction as defined by ECHO parameters
-18-75years
-3/week HD or nocturnal HD or frequent HD with optimised UF (adequacy as assessed as per discretion of nephrologist)
Exclusion Criteria
-Age < 18 years and > 75 years
- Non-compliant with medications/ dialysis (assessed as per discretion of nephrologist), Interdialytic weight gain > 3.5 litres
-Refractory hyperkalemia defined at pre-dialyisis potassium > 6mmol/L
-Clinical significant/ life-threatening Infection, requiring hospitalization in last 3 months
-Malignancy
-Pregnancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method composite of cardiovascular death, MACE, hospitalization for heart failure, death from any causeTimepoint: 3 months and 6 months
- Secondary Outcome Measures
Name Time Method Incidence of hypotensive episodes after starting study drug, as assessed by nephrologist <br/ ><br>Incidence of pre-dialysis hyperkalemia more than 6mmol/L <br/ ><br>Timepoint: 6 months