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

NCT01687699 | Completed Phase 4

• 1 other identifier: dohas01
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 1

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.

Conditions

End-stage Renal Failure

Keywords

cardiovascular event; hemodialysis; spironolactone

Outcome Measures

Primary Outcomes (1)

• cardio- and cerebrovascular events

Secondary Outcomes (1)

• death from all causes

Study Arms (1)

spironolactone

EXPERIMENTAL

Drug: Spironolactone

Interventions

Spironolactone DRUG

spironolactone

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Dialysis Outcomes Heart Failure Aldactone Study Group: lead

Study Sites (1)

Shibukawa Clinic

Shizuoka, Shizuoka, 424-0053, Japan

Location

Related Publications (2)

• 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.

  PMID: 33586138 DERIVED

• 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.

  PMID: 24184249 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Spironolactone

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD., PhD.

Study Record Dates

• First Submitted: September 12, 2012
• First Posted: September 19, 2012
• Study Start: April 1, 2008
• Primary Completion: December 1, 2008
• Last Updated: September 19, 2012

Record last verified: 2012-09

Locations

JP (1)