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CompletedNCT01687699Updated Sep 19, 2012

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

A Phase 4 interventional study of Spironolactone in End-stage Renal Failure, sponsored by Dialysis Outcomes Heart Failure Aldactone Study Group. Completed at 1 site in Japan. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2012-09-19.

Sponsored by Dialysis Outcomes Heart Failure Aldactone Study Group · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
157
Allocation
Not applicable
Ages
30 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • End-stage Renal Failure

Keywords

  • cardiovascular event
  • hemodialysis
  • spironolactone
03

In context

Kidney Failure, Chronic

2,085 studies on the registry are indexed under Kidney Failure, Chronic; 260 are open to participants now.

This study's enrollment of 157 is above the median of 55 across 1,557 interventional studies indexed under Kidney Failure, Chronic.

Browse Kidney Failure, Chronic studies →

Lead sponsor

This is the only study on the registry with Dialysis Outcomes Heart Failure Aldactone Study Group as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years and older
Sexes eligible
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

Exclusion Criteria:

  • A history of noncompliance
  • Unstable vascular access
  • Hypotension
  • Hepatic failure
  • Active cancer
  • Any life-threatening disease other than ESRD
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
Single (Outcomes assessor)
Enrollment
157 participants (actual)

Study arms

  • Experimental
    spironolactone

    Drug: Spironolactone

Interventions

  • DrugSpironolactone
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What researchers measure

Primary outcomes

  1. cardio- and cerebrovascular events

Secondary outcomes

  1. death from all causes

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Study locations

1 site
  • Shibukawa Clinic
    Shizuoka, 424-0053, Japan
08

References and documents

Publications

  • Hasegawa T, Nishiwaki H, Ota E, Levack WM, Noma H. Aldosterone antagonists for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2021 Feb 15;2(2):CD013109. doi: 10.1002/14651858.CD013109.pub2. PubMed 33586138 ↗
  • 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. PubMed 24184249 ↗

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01687699
Lead sponsor
Dialysis Outcomes Heart Failure Aldactone Study Group
Responsible party
Yoshihiro Matsumoto (MD., PhD., Dialysis Outcomes Heart Failure Aldactone Study Group) — Principal investigator
First posted
Sep 19, 2012
Start date
Apr 2008
Primary completion
Dec 2008
Last update
Sep 19, 2012
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.

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