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

September 12, 2012
September 14, 2012
April 2008
December 2008   (final data collection date for primary outcome measure)
cardio- and cerebrovascular events
Same as current
Complete list of historical versions of study NCT01687699 on ClinicalTrials.gov Archive Site
death from all causes
Same as current
Not Provided
Not Provided
 
Effects of Spironolactone on Cardio- and Cerebrovascular Morbidity and Mortality in Hemodialysis Patients
Not Provided

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.

Not Provided
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
End-stage Renal Failure
Drug: Spironolactone
Experimental: spironolactone
Intervention: Drug: Spironolactone
Matsumoto Y, Mori Y, Kageyama S, Arihara K, Sugiyama T, Ohmura H, Yakushigawa T, Sugiyama H, Shimada Y, Nojima Y, Shio N. Spironolactone reduces cardiovascular and cerebrovascular morbidity and mortality in hemodialysis patients. J Am Coll Cardiol. 2014 Feb 18;63(6):528-36. doi: 10.1016/j.jacc.2013.09.056. Epub 2013 Oct 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
157
Not Provided
December 2008   (final data collection date for primary outcome measure)

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
Both
30 Years and older
Not Provided
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01687699
dohas01
Not Provided
Yoshihiro Matsumoto, Dialysis Outcomes Heart Failure Aldactone Study Group
Dialysis Outcomes Heart Failure Aldactone Study Group
Not Provided
Not Provided
Dialysis Outcomes Heart Failure Aldactone Study Group
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP