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

NCT ID: NCT01687699

Last Updated: 2012-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

157 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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End-stage Renal Failure

Keywords

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cardiovascular event hemodialysis spironolactone

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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spironolactone

Group Type EXPERIMENTAL

Spironolactone

Intervention Type DRUG

Interventions

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Spironolactone

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dialysis Outcomes Heart Failure Aldactone Study Group

OTHER

Sponsor Role lead

Responsible Party

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Yoshihiro Matsumoto

MD., PhD.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shibukawa Clinic

Shizuoka, Shizuoka, Japan

Site Status

Countries

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Japan

References

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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.

Reference Type DERIVED
PMID: 33586138 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24184249 (View on PubMed)

Related Links

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http://www.ncbi.nlm.nih.gov/pubmed/19342857

Related Info

Other Identifiers

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dohas01

Identifier Type: -

Identifier Source: org_study_id