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
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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
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