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Cardiovascular Protective Effect of Spironolactone in Hemodialysis

Information source: Universidad Los Andes, Chile
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hemodialysis

Intervention: Spironolactone (drug) (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Universidad Los Andes, Chile

Official(s) and/or principal investigator(s):
Luis F Michea, MD PhD, Study Chair, Affiliation: Faculty of Medicine, University Los Andes

Overall contact:
Antonio Vukusich, MD, Phone: 56-2-7308021, Email: avukusic@davila.cl

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.

Clinical Details

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

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

Detailed 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.

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

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

-

Locations and Contacts

Antonio Vukusich, MD, Phone: 56-2-7308021, Email: avukusic@davila.cl

Clinica Davila, Santiago, Chile; Recruiting
Antonio Vukusich, MD, Phone: 56-2-7308021, Email: avukusic@davila.cl
Elisa T Marusic, PhD, Phone: 56-2-4129341, Email: emarusic@uandes.cl
Antonio Vukusich, MD, Principal Investigator
Additional Information

Related publications:

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.


Last updated: January 12, 2006

Page last updated: August 23, 2015

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