Aldosterone BloCkade for Health Improvement EValuation in End-stage Renal Disease
Endstage Renal DiseaseIndividuals 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.
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Participation Requirements
-
Sex:
ALL -
Eligible Ages:
18 and up
Participation 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
Study Location
University of Alberta
University of AlbertaEdmonton, Alberta
Canada
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Penticton Regional Hospital
Penticton Regional HospitalPenticton, British Columbia
Canada
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Queens University at Kingston General Hospital, Division of Nephrology
Queens University at Kingston General Hospital, Division of NephrologyKingston, Ontario
Canada
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Rachel Holden, MD
St. Michael's Hospital
St. Michael's HospitalToronto, Ontario
Canada
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Ron Wald, MD
Hopital du Sacre-Coeur de Montreal
Hopital du Sacre-Coeur de MontrealMontreal, Quebec
Canada
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Francois Madore, MD
Foothills Hospital
Foothills HospitalCalgary, Alberta
Canada
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Braden Manns, MD
St. Pauls Hospital
St. Pauls HospitalVancouver, British Colombia
Canada
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St. Joseph's Healthcare
St. Joseph's HealthcareHamilton, Ontario
Canada
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Health Sciences North Research Institute
Health Sciences North Research InstituteSudbury, Ontario
Canada
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CIUSSS Hopital Maisonneuve- Rosemont
CIUSSS Hopital Maisonneuve- RosemontMontreal, Quebec
Canada
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CHU de Quebec L'Hotel-Dieu de Quebec
CHU de Quebec L'Hotel-Dieu de QuebecQuébec, Quebec
Canada
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Sacha DeSerres, MD
Royal Inland Hospital
Royal Inland HospitalKamloops, British Colombia
Canada
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Queen Elizabeth II Health Science Centre
Queen Elizabeth II Health Science CentreHalifax, Nova Scotia
Canada
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Steven D Soroka, MD
9024732099Victoria Hospital
Victoria HospitalLondon, Ontario
Canada
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Matthew Weir, MD
St. Josephs, Toronto
St. Josephs, TorontoToronto, Ontario
Canada
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The Sir Mortimer B. Davis Jewish General Hospital
The Sir Mortimer B. Davis Jewish General HospitalMontreal, Quebec
Canada
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Kelowna General Hospital
Kelowna General HospitalKelowna, British Colombia
Canada
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Marie Michaud, MD
Cape Breton Regional Hospital
Cape Breton Regional HospitalSydney, Nova Scotia
Canada
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Ottawa Hospital Research Institute
Ottawa Hospital Research InstituteOttawa, Ontario
Canada
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Debra Zimmerman, MD
Humber River Health
Humber River HealthToronto, Ontario
Canada
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Centre Hospitalier de l'Universite de Montreal (CHUM)
Centre Hospitalier de l'Universite de Montreal (CHUM)Montréal, Quebec
Canada
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William Beaubien-Souligny, MD
- Study Sponsored By
- Population Health Research Institute
- Participants Required
- More Information
- Study ID:
NCT03020303