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Effects of Spironolactone on Cardio- and Cerebrovascular Morbidity and Mortality in Hemodialysis Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yoshihiro Matsumoto, Dialysis Outcomes Heart Failure Aldactone Study Group
ClinicalTrials.gov Identifier:
NCT01687699
First received: September 12, 2012
Last updated: September 14, 2012
Last verified: September 2012
History of Changes
  Purpose

Aldosterone receptor blockers reduce cardiac-related morbidity and mortality. Recently, we demonstrated that long-term low-dose spironolactone is clinically safe in many hemodialysis (HD) patients. In the present study, we assess whether low-dose spironolactone treatment reduces the high incidence of cardio- and cerebrovascular (CCV) morbidity and mortality in HD patients. The investigators' hypothesis is that aldosterone receptor blockade by spironolactone reduces the risk of both CCV morbidity and death among HD patients.


Condition Intervention Phase
End-stage Renal Failure
 Drug: Spironolactone
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Dialysis Outcomes Heart Failure Aldactone Study Group:

Primary Outcome Measures:
  • cardio- and cerebrovascular events

Secondary Outcome Measures:
  • death from all causes

Enrollment: 157
Study Start Date: April 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: spironolactone Drug: Spironolactone

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Hemodialysis patients undergoing 4-hour-long HD thrice a week for at least 2 years
  • With an average serum potassium level (immediately before dialysis on the first day of the week) of <6.5 mEq/l over the previous 2 months
  • With a 24-hour urine output of <500 ml

Exclusion Criteria:

  • A history of noncompliance
  • Unstable vascular access
  • Hypotension
  • Hepatic failure
  • Active cancer
  • Any life-threatening disease other than ESRD
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01687699

Locations
Japan
Shibukawa Clinic
Shizuoka, Japan, 424-0053
Sponsors and Collaborators
Dialysis Outcomes Heart Failure Aldactone Study Group
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Yoshihiro Matsumoto, MD., PhD., Dialysis Outcomes Heart Failure Aldactone Study Group
ClinicalTrials.gov Identifier: NCT01687699     History of Changes
Other Study ID Numbers: dohas01
Study First Received: September 12, 2012
Last Updated: September 14, 2012
Health Authority: Japan: Institutional Review Board

Keywords provided by Dialysis Outcomes Heart Failure Aldactone Study Group:
cardiovascular event
hemodialysis
spironolactone

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Spironolactone
Aldosterone Antagonists
Hormone Antagonists
 Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Diuretics
Natriuretic Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013