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Cardiovascular Protective Effect of Spironolactone in Hemodialysis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00277693
Recruitment Status : Unknown
Verified December 2005 by Universidad de los Andes, Chile.
Recruitment status was:  Recruiting
First Posted : January 16, 2006
Last Update Posted : January 16, 2006
Information provided by:
Universidad de los Andes, Chile

Brief 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.

Condition or disease Intervention/treatment Phase
Hemodialysis Drug: Spironolactone (drug) Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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 the National Library of Medicine

MedlinePlus related topics: Dialysis

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00277693

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Contact: Antonio Vukusich, MD 56-2-7308021

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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
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Study Chair: Luis F Michea, MD PhD Faculty of Medicine, University Los Andes

Layout table for additonal information Identifier: NCT00277693    
Other Study ID Numbers: 1040338
First Posted: January 16, 2006    Key Record Dates
Last Update Posted: January 16, 2006
Last Verified: December 2005
Keywords provided by Universidad de los Andes, Chile:
heart failure
Additional relevant MeSH terms:
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Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Natriuretic Agents