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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01687699
Recruitment Status : Completed
First Posted : September 19, 2012
Last Update Posted : September 19, 2012
Information provided by (Responsible Party):
Yoshihiro Matsumoto, Dialysis Outcomes Heart Failure Aldactone Study Group

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

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
Experimental: spironolactone Drug: Spironolactone

Primary Outcome Measures :
  1. cardio- and cerebrovascular events

Secondary Outcome Measures :
  1. death from all causes

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT01687699

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Shibukawa Clinic
Shizuoka, Japan, 424-0053
Sponsors and Collaborators
Dialysis Outcomes Heart Failure Aldactone Study Group
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Yoshihiro Matsumoto, MD., PhD., Dialysis Outcomes Heart Failure Aldactone Study Group Identifier: NCT01687699    
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
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Natriuretic Agents