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NCT00277693 Clinical Trial

Cardiovascular Protective Effect of Spironolactone in Hemodialysis

Hemodialysis Clinical Trial

Official title:
Protective Mechanisms of Aldosterone Antagonists and Their Effects on Cardiovascular Damage in Chronic Renal Failure: Clinical and Experimental Studies

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00277693
Other study ID # 1040338
Secondary ID
Status Recruiting
Phase Phase 4
First received January 12, 2006
Last updated January 12, 2006

Study information
Verified date December 2005
Source Universidad Los Andes, Chile
Contact Antonio Vukusich, MD
Phone 56-2-7308021
Email avukusic@davila.cl
Is FDA regulated No
Health authority Chile: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of the present study is to determine if spironolactone is safe and effective in the treatment of cardiovascular complications in hemodialysis patients.

Description:

Cardiovascular complications are common in dialysis patients and comprise up to 50% of deaths in end-stage renal disease population. Hypertension and left ventricle hypertrophy occur in more than 70% of patients undergoing long-term hemodialysis therapy, and both contributes to mortality and morbidity.Recent clinical trials in chronic heart failure and post miocardial infarct heart failure patients have demonstrated a beneficial effect of a mineralocorticoid receptor blocker spironolactone, in adittion to standard therapy (RALES AND EPHESUS studies). The aim of the present study is to evaluate spironolactone treatment in hemodialysis patients.

Recruitment information / eligibility
Status Recruiting
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

chronic hemodialysys (> 3 months) anuria (diuresis <200 mL/day) -

Exclusion Criteria:

Liver failure Insulin dependent diabetes Treatment with adrenergic beta blockers or agonists Treatment with converting-enzime blocker or angiotensin receptor antagonists Cancer

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Spironolactone (drug)

Locations
Country Name City State
Chile Clinica Davila Santiago

Sponsors (1)
Lead Sponsor Collaborator
Universidad Los Andes, Chile

Country where clinical trial is conducted

Chile, 

References & Publications (1)

Michea L, Vukusich A, González M, Zehnder C, Marusic ET. Effect of spironolactone on K(+) homeostasis and ENaC expression in lymphocytes from chronic hemodialysis patients. Kidney Int. 2004 Oct;66(4):1647-53. — View Citation

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