MedTrace Logo

Aldosterone Antagonist Therapy for Adults With Heart Failure and Preserved Systolic Function

NCT00094302 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3445

Last updated 2015-03-02

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to evaluate the effectiveness of aldosterone antagonist therapy in reducing cardiovascular mortality, aborted cardiac arrest, and heart failure hospitalization in patients who have heart failure with preserved systolic function.

Conditions

Interventions

DRUG

Spironolactone

Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.

DRUG

Placebo

Placebo of spironolactone

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Carelon Research

    lead OTHER

Principal Investigators

  • Sonja M. McKinlay, PhD · New England Research Institutes, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • United States
  • Argentina
  • Brazil
  • Canada
  • Georgia
  • Russia

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00094302 on ClinicalTrials.gov