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Mineralocorticoid Receptor Antagonist

Spironolactone in Adult Congenital Heart Disease

Phase 2
Waitlist Available
Led By Craig Broberg, MD
Research Sponsored by Oregon Health and Science University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 month
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions

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.

Eligible Conditions
  • Endomyocardial Fibrosis
  • Congenital Heart Disease
  • Congestive Heart Failure
  • Heart Failure
  • Restrictive Cardiomyopathy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Extracellular Volume Fraction
Secondary study objectives
6-minute Walk Distance

Side effects data

From 2017 Phase 2 & 3 trial • 20 Patients • NCT02585843
10%
Hyperkalemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
High-dose
Standard of Care

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SpironolactoneExperimental Treatment1 Intervention
Spironolactone 25 mg daily
Group II: PlaceboPlacebo Group1 Intervention
Patients will receive placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Spironolactone
FDA approved

Find a Location

Who is running the clinical trial?

Oregon Clinical and Translational Research InstituteOTHER
16 Previous Clinical Trials
765 Total Patients Enrolled
Oregon Health and Science UniversityLead Sponsor
1,008 Previous Clinical Trials
7,414,269 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,944 Previous Clinical Trials
47,799,792 Total Patients Enrolled
Craig Broberg, MDPrincipal InvestigatorOregon Health and Science University
~3 spots leftby Dec 2025
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