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Cardiovascular Protective Effect of Spironolactone in Hemodialysis

U

Universidad de los Andes, Chile

Status and phase

Unknown
Phase 4

Conditions

Hemodialysis

Treatments

Drug: Spironolactone (drug)

Study type

Interventional

Funder types

Other

Identifiers

NCT00277693
1040338

Details and patient eligibility

About

The purpose of the present study is to determine if spironolactone is safe and effective in the treatment of cardiovascular complications in hemodialysis patients.

Full 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.

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

1

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Central trial contact

Antonio Vukusich, MD

Data sourced from clinicaltrials.gov

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