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Status unknownNCT00277693Updated Jan 16, 2006

Cardiovascular Protective Effect of Spironolactone in Hemodialysis

A Phase 4 interventional study of Spironolactone (drug) in Hemodialysis, sponsored by Universidad de los Andes, Chile. Status unknown at 1 site in Chile. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2006-01-16.

Sponsored by Universidad de los Andes, Chile · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2005), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Hemodialysis

Keywords

  • hemodialysis
  • aldosterone
  • heart failure
  • spironolactone
03

In context

Lead sponsor

Universidad de los Andes, Chile is the lead sponsor of 44 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All

Inclusion criteria

chronic hemodialysys (> 3 months) anuria (diuresis \<200 mL/day) -

Exclusion criteria

Exclusion Criteria:

Liver failure Insulin dependent diabetes Treatment with adrenergic beta blockers or agonists Treatment with converting-enzime blocker or angiotensin receptor antagonists Cancer

-

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double

Interventions

  • DrugSpironolactone (drug)
06

Study locations

1 of 1 sites recruiting
  • Clinica Davila
    Santiago, Chile
    • Antonio Vukusich, MD · Contact · avukusic@davila.cl · 56-2-7308021
    • Elisa T Marusic, PhD · Contact · emarusic@uandes.cl · 56-2-4129341
    • Antonio Vukusich, MD · Principal investigator
    Recruiting
07

References and documents

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. doi: 10.1111/j.1523-1755.2004.00931.x. PubMed 15458462 ↗
  • 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. PubMed 33586138 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 16, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00277693
Lead sponsor
Universidad de los Andes, Chile
First posted
Jan 16, 2006
Last update
Jan 16, 2006

Study contacts

Antonio Vukusich, MD
Contact
avukusic@davila.cl
56-2-7308021
Luis F Michea, MD PhD
study chair · Faculty of Medicine, University Los Andes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2005. You cannot join it, but the record below documents what was studied.

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