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

NCT03020303 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2538

Last updated 2025-03-20

No results posted yet for this study

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.

Conditions

  • Endstage Renal Disease

Interventions

DRUG

Spironolactone 25Mg Tablet

Randomized participants will receive a study supply of spironolactone 25 mg tablets. They will be instructed to take 1 tablet daily.

DRUG

Placebo Oral Tablet

Randomized participants will receive a study supply of placebo tablets with no active medical ingredients. They will be instructed to take 1 tablet daily.

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Population Health Research Institute

    lead OTHER

Principal Investigators

  • Michael Walsh, MD, PhD · McMaster University

  • PJ Devereaux, MD, PhD · McMaster University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-07
Primary Completion
2025-03-14
Completion
2025-03-14

Countries

  • Australia
  • Brazil
  • Canada
  • China
  • Ecuador
  • India
  • Malaysia
  • New Zealand
  • Philippines
  • Turkey (Türkiye)
  • United Kingdom
  • Uruguay

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03020303 on ClinicalTrials.gov