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Cardiovascular Protective Effect of Spironolactone in Hemodialysis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2005 by Universidad Los Andes, Chile.
Recruitment status was:  Recruiting
Information provided by:
Universidad Los Andes, Chile Identifier:
First received: January 12, 2006
Last updated: NA
Last verified: December 2005
History: No changes posted
The purpose of the present study is to determine if spironolactone is safe and effective in the treatment of cardiovascular complications in hemodialysis patients.

Condition Intervention Phase
Hemodialysis Drug: Spironolactone (drug) Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Protective Mechanisms of Aldosterone Antagonists and Their Effects on Cardiovascular Damage in Chronic Renal Failure: Clinical and Experimental Studies

Resource links provided by NLM:

Further study details as provided by Universidad Los Andes, Chile:

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.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All

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

  Contacts and Locations
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Please refer to this study by its identifier: NCT00277693

Contact: Antonio Vukusich, MD 56-2-7308021

Clinica Davila Recruiting
Santiago, Chile
Contact: Antonio Vukusich, MD    56-2-7308021   
Contact: Elisa T Marusic, PhD    56-2-4129341   
Principal Investigator: Antonio Vukusich, MD         
Sponsors and Collaborators
Universidad Los Andes, Chile
Study Chair: Luis F Michea, MD PhD Faculty of Medicine, University Los Andes
  More Information

Publications: Identifier: NCT00277693     History of Changes
Other Study ID Numbers: 1040338
Study First Received: January 12, 2006
Last Updated: January 12, 2006

Keywords provided by Universidad Los Andes, Chile:
heart failure

Additional relevant MeSH terms:
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Natriuretic Agents processed this record on July 27, 2017