CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 80 enrolled
Drug / intervention
Spironolactone +1 moredrug
Likely dose
Spironolactone 25 mg orally once dailyAI-extracted
Key inclusion· 4
  • ✓Age 60 or older
  • ✓Diagnosis of diastolic heart failure
  • ✓Ambulatory status
  • ✓Medically stable
Key exclusion· 11
  • ✕Valvular heart disease
  • ✕Significant change in cardiac medication within the past 4 weeks
  • ✕Uncontrolled hypertension
  • ✕Recent or debilitating stroke

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00123955
NCT00123955Phase 3Completed
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Exercise Intolerance in Elderly Diastolic Heart Failure

Wake Forest University·interventional·Posted Jul 26, 2005·Updated Feb 27, 2019

In Brief

A Phase 3 clinical trial evaluating Spironolactone and Placebo for Diastolic Heart Failure and Heart Failure, Congestive. Completed, enrolled 80 participants across 1 site.

Detailed Summary

The purpose of this study is to examine whether spironolactone will improve exercise tolerance and quality of life in elderly patients with heart failure preserved ejection fraction (HFPEF).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiastolic Heart Failure, Heart Failure, Congestive
CountriesUnited States
CollaboratorsNational Institute on Aging (NIA)

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 26, 2005
Enrollment StartApr 1, 2005
Primary CompletionJun 1, 2009
Study CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 20.9 years ago

Interventions

Spironolactonedrug

25mg tablet daily for 9 months

Placebodrug

Placebo tablet daily for 9 months