NCT00277693

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 16, 2006

Completed
Last Updated

January 16, 2006

Status Verified

December 1, 2005

First QC Date

January 12, 2006

Last Update Submit

January 12, 2006

Conditions

Hemodialysis

Keywords

hemodialysisaldosteroneheart failurespironolactone

Interventions

Spironolactone (drug)DRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinica Davila

Santiago, Santiago Metropolitan, Chile

RECRUITING

Related Publications (2)

  • 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.

    PMID: 15458462BACKGROUND

  • 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.

    PMID: 33586138DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

SpironolactonePharmaceutical Preparations

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

LactonesOrganic ChemicalsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Luis F Michea, MD PhD

    Faculty of Medicine, University Los Andes

    STUDY CHAIR

Central Study Contacts

Antonio Vukusich, MD

CONTACT

56-2-7308021avukusic@davila.cl

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 12, 2006

First Posted

January 16, 2006

Last Updated

January 16, 2006

Record last verified: 2005-12

Locations

CL(1)