Cardiovascular Protective Effect of Spironolactone in Hemodialysis

This study is currently recruiting participants.

Verified by Universidad Los Andes, December 2005

First Received: January 12, 2006 No Changes Posted

Sponsored by:	Universidad Los Andes
Information provided by:	Universidad Los Andes
ClinicalTrials.gov Identifier:	NCT00277693

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Dialysis Kidney Failure

Drug Information available for: Spironolactone Aldosterone

U.S. FDA Resources

Further study details as provided by Universidad Los Andes:

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

Contacts and Locations

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

Investigators

Study Chair:

Luis F Michea, MD PhD

Faculty of Medicine, University Los Andes

More Information

Publications:

Michea L, Vukusich A, Gonzalez 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.

Study ID Numbers:	1040338
Study First Received:	January 12, 2006
Last Updated:	January 12, 2006
ClinicalTrials.gov Identifier:	NCT00277693 History of Changes
Health Authority:	Chile: Institutional Review Board

Keywords provided by Universidad Los Andes:

hemodialysis
aldosterone
heart failure
spironolactone

Study placed in the following topic categories:

Heart Failure
Aldosterone Antagonists
Hormone Antagonists
Diuretics
Hormones, Hormone Substitutes, and Hormone Antagonists

Kidney Failure, Chronic
Cardiovascular Agents
Hormones
Spironolactone
Kidney Failure

Additional relevant MeSH terms:

Aldosterone Antagonists
Natriuretic Agents
Therapeutic Uses
Hormone Antagonists
Diuretics

Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Cardiovascular Agents
Pharmacologic Actions
Spironolactone

ClinicalTrials.gov processed this record on July 02, 2009