Overview

Aldosterone bloCkade for Health Improvement EValuation in End-stage Renal Disease

Status:
Recruiting

Trial end date:
2023-09-01

Target enrollment:
0

Participant gender:
All

Summary

Individuals receiving dialysis are at risk of heart failure and heart related death. There is an urgent need for treatments that reduce the risk of these problems in patients that require dialysis. Spironolactone is a pill used to prevent heart failure and related deaths in patients that do not require dialysis. It works by blocking a hormone (aldosterone) in your body that causes high blood pressure and can damage the heart. Although spironolactone is very effective in patients that do not require dialysis, we do not know if spironolactone is effective in dialysis patients. Our research will help determine if spironolactone reduces heart failure and heart related deaths in dialysis patients. The purpose of this study is to determine if spironolactone reduces death or hospitalization for heart failure and is well tolerated in patients that require dialysis.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Population Health Research Institute

Collaborator:

Canadian Institutes of Health Research (CIHR)

Treatments:

Spironolactone

Criteria

Inclusion Criteria:

1. Age

1. ≥45 years or

2. ≥18 with a history of diabetes

2. On dialysis ≥ 90 days

3. On either

1. Hemodialysis prescribed at least 2 treatments per week or

2. Peritoneal dialysis prescribed with at least 1 exchange daily

4. Provides informed consent

Exclusion Criteria:

1. Hyperkalemia

1. Serum potassium >5.8 mmol/L in the 6 weeks prior to enrollment or

2. 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.

8. Treating physician believes either spironolactone is either absolutely indicated or
absolutely contra-indicated