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Cardiovascular Protective Effect of Spironolactone in Hemodialysis

NCT ID: NCT00277693

Last Updated: 2006-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Brief Summary

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

Detailed Description

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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.

Conditions

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Hemodialysis

Keywords

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hemodialysis aldosterone heart failure spironolactone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Spironolactone (drug)

Intervention Type DRUG

Eligibility Criteria

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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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Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad de los Andes, Chile

OTHER

Sponsor Role lead

Principal Investigators

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Luis F Michea, MD PhD

Role: STUDY_CHAIR

Faculty of Medicine, University Los Andes

Locations

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Clinica Davila

Santiago, Santiago Metropolitan, Chile

Site Status RECRUITING

Countries

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Chile

Central Contacts

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Antonio Vukusich, MD

Role: CONTACT

Phone: 56-2-7308021

Email: [email protected]

Facility Contacts

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Antonio Vukusich, MD

Role: primary

Elisa T Marusic, PhD

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 15458462 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33586138 (View on PubMed)

Other Identifiers

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1040338

Identifier Type: -

Identifier Source: org_study_id