Evaluation of spironolactone on heart related mortality and morbidity among patients undergoing chronic kidney dialysis
- Conditions
- Health Condition 1: N186- End stage renal disease
- Registration Number
- CTRI/2019/06/019703
- Lead Sponsor
- Population Health Research Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1. Age >=18 with a history of diabetes
2. On dialysis >= 90 days
3. On either
a. Hemodialysis prescribed at least 2 treatments per week or
b. Peritoneal dialysis prescribed with at least 1 exchange daily
4. Provides informed consent
1. Hyperkalemia
a. Serum potassium >5.8 mmol/L in the 6 weeks prior to enrollment or
b. Serum potassium >6.0 mmol/L during active run-in
2. Currently taking and unable to withdraw a mineralocorticoid receptor
antagonist (i.e. spironolactone or eplerenone).
3. Known sensitivity or allergy to spironolactone
4. Current or planned pregnancy or breastfeeding
5. Scheduled living related donor renal transplant
6. Life expectancy < 6 months in the opinion of a treating nephrologist.
7. Enrolled in another interventional trial testing a mineralocorticoid receptor antagonist or drug that has a known or likely interaction with
spironolactone.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Composite of cardiac death or hospitalization for heart failureTimepoint: Months 3, 6, 12, 18, 24, 30, 36,42,48,54, 60
- Secondary Outcome Measures
Name Time Method 1 Cause specific death (cardiac, other vascular, non-vascular) <br/ ><br>2 Hospitalization for heart failure <br/ ><br>3 All-cause death <br/ ><br>4 All-cause hospitalizations <br/ ><br>5 Hospitalization for hyperkalemia <br/ ><br>Timepoint: Months 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60