Spironolactone in Adult Congenital Heart Disease
Condition: Congenital Heart Disease; Heart Failure; Endomyocardial Fibrosis
MeSH terms: Heart Failure; Heart Diseases; Heart Defects, Congenital; Endomyocardial Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): Spironolactone 25mg; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Spironolactone 25 mg daily for 12 months; Placebo daily for 12 months
Other intervention name(s): Aldactone 25 mg daily
Intervention MeSH terms: Spironolactone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment