CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
Spironolactone 25mg +1 moredrug
Likely dose
Spironolactone 25mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT01069510
NCT01069510Phase 2Completed
CompareCT.gov

Heart Failure in Congenital Heart Disease: the Role of Myocardial Fibrosis. Treatment Sub-Study: Spironolactone vs. Placebo

Oregon Health and Science University·interventional·Posted Feb 17, 2010·Updated Aug 21, 2019

In Brief

A Phase 2 clinical trial evaluating Spironolactone 25mg and Placebo for Congenital Heart Disease and 2 related conditions. Completed, enrolled 40 participants across 1 site.

Detailed Summary

The purpose of this study is to see if the study drug called spironolactone reduces fibrous (stiffening) in heart muscle tissue and improves heart function. Subjects from the study titled "Heart Failure in Congenital Heart Disease: the role of myocardial fibrosis" who have evidence of heart dysfunction and/or evidence of fibrosis (stiffening) in the heart muscle will be asked to take part in this study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCongenital Heart Disease, Heart Failure, Endomyocardial Fibrosis
CountriesUnited States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI), Oregon Clinical and Translational Research Institute

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 17, 2010
Enrollment StartFeb 1, 2010
Primary CompletionJun 1, 2016
Study CompletionMar 1, 2017
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 16.4 years ago

Interventions

Spironolactone 25mgdrug

Spironolactone 25 mg daily for 12 months

Placeboother

Placebo daily for 12 months