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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
Sponsor:
ClinicalTrials.gov Identifier:
NCT00277693
First Posted: January 16, 2006
Last Update Posted: January 16, 2006
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.
Information provided by:
Universidad Los Andes, Chile
  Purpose
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
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.
  Eligibility

Information from the National Library of Medicine

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

  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00277693


Contacts
Contact: Antonio Vukusich, MD 56-2-7308021 avukusic@davila.cl

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

Publications:
ClinicalTrials.gov Identifier: NCT00277693     History of Changes
Other Study ID Numbers: 1040338
First Submitted: January 12, 2006
First Posted: January 16, 2006
Last Update Posted: January 16, 2006
Last Verified: December 2005

Keywords provided by Universidad Los Andes, Chile:
hemodialysis
aldosterone
heart failure
spironolactone

Additional relevant MeSH terms:
Spironolactone
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents