Clinical Trial: Spironolactone in Adult Congenital Heart Disease

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional



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

Brief 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.

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