Cardiovascular Protective Effect of Spironolactone in Hemodialysis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2005 by Universidad Los Andes, Chile.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Universidad Los Andes, Chile
ClinicalTrials.gov Identifier:
NCT00277693
First received: January 12, 2006
Last updated: NA
Last verified: December 2005
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   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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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: January 12, 2006
Last Updated: January 12, 2006
Health Authority: Chile: Institutional Review Board

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
Pharmacologic Actions
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014