NCT01069510

Spironolactone in Adult Congenital Heart Disease

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study will include randomizing the subject to receive the study drug or placebo. Randomization will occur during visit 1. Visit 1 will include the following: * Subjects will answer questions about how well they can breathe. * An MRI. Dye called gadolinium will be injected into the subject's vein. * They will go to the Oregon Clinical and Translational Research Institute where 2 tablespoons of blood will be drawn from an intravenous (IV) catheter (tube). * They will do a 6 minute walk test.. * They will also have an echocardiogram, which is a test that looks at the movement of the subject's heart. A technician will place a cool jelly on their chest and use a small wand to take pictures through the skin. Subjects' will also have visits 3-6 weeks, 3, 6, 9 months, and 12 months after randomization. Visits 2-5 will include the following: * They will go to the Oregon Clinical and Translational Research Institute where 1/2 tablespoon of blood will be drawn. * They will do a 6 minute walk test. During this test, they will walk back and forth in a hallway. The goal is to walk as far as possible for 6 minutes. Subjects will probably get out of breath or become exhausted. If they do, they can slow down, stop, or rest as they need to. Blood pressure will be taken before the walk. * They will have a health review at 6 months. Visit 6 will be identical to visit 1 and include the following: * Subjects will answer questions about how well they can breathe. * An MRI. Dye called gadolinium will be injected into the subject's vein. * They will go to the Oregon Clinical and Translational Research Institute where 2 tablespoons of blood will be drawn from an intravenous (IV) catheter (tube). * They will do a 6 minute walk test.. * They will also have an echocardiogram, which is a test that looks at the movement of the subject's heart. A technician will place a cool jelly on their chest and use a small wand to take pictures through the skin. The investigators will compare the study drug, called spironolactone, to placebo with regard to any changes in heart stiffening and function of the heart.

Conditions

• Congenital Heart Disease
• Heart Failure
• Endomyocardial Fibrosis

Interventions

Type	Name	Description
DRUG	Spironolactone 25mg	Spironolactone 25 mg daily for 12 months
OTHER	Placebo	Placebo daily for 12 months

Timeline

• Start date: 2010-02-01
• Primary completion: 2016-06-01
• Completion: 2017-03-01
• First posted: 2010-02-17
• Last updated: 2019-08-21
• Results posted: 2019-08-21

Locations

1 site across 1 country: United States