- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00277693
Cardiovascular Protective Effect of Spironolactone in Hemodialysis
January 12, 2006 updated by: Universidad de los Andes, Chile
Protective Mechanisms of Aldosterone Antagonists and Their Effects on Cardiovascular Damage in Chronic Renal Failure: Clinical and Experimental Studies
The purpose of the present study is to determine if spironolactone is safe and effective in the treatment of cardiovascular complications in hemodialysis patients.
Study Overview
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.
Study Type
Interventional
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Antonio Vukusich, MD
- Phone Number: 56-2-7308021
- Email: avukusic@davila.cl
Study Locations
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Santiago, Chile
- Recruiting
- Clinica Dávila
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Contact:
- Antonio Vukusich, MD
- Phone Number: 56-2-7308021
- Email: avukusic@davila.cl
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Contact:
- Elisa T Marusic, PhD
- Phone Number: 56-2-4129341
- Email: emarusic@uandes.cl
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Principal Investigator:
- Antonio Vukusich, MD
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
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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Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Luis F Michea, MD PhD, Faculty of Medicine, University Los Andes
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Hasegawa T, Nishiwaki H, Ota E, Levack WM, Noma H. Aldosterone antagonists for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2021 Feb 15;2(2):CD013109. doi: 10.1002/14651858.CD013109.pub2.
- 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. doi: 10.1111/j.1523-1755.2004.00931.x.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
January 12, 2006
First Submitted That Met QC Criteria
January 12, 2006
First Posted (Estimate)
January 16, 2006
Study Record Updates
Last Update Posted (Estimate)
January 16, 2006
Last Update Submitted That Met QC Criteria
January 12, 2006
Last Verified
December 1, 2005
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1040338
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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