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

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ClinicalTrials.gov Identifier: NCT01687699
Recruitment Status : Completed
First Posted : September 19, 2012
Last Update Posted : September 19, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
End-stage Renal Failure Drug: Spironolactone Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 157 participants
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Study Start Date : April 2008
Primary Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: spironolactone Drug: Spironolactone


Outcome Measures

Primary Outcome Measures :
  1. cardio- and cerebrovascular events

Secondary Outcome Measures :
  1. death from all causes

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01687699


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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: September 19, 2012    Key Record Dates
Last Update Posted: September 19, 2012
Last Verified: September 2012

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

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Spironolactone
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents