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Congenital Heart Disease | Spironolactone in Adult Congenital Heart Disease

Congenital Heart Disease research study

What is the primary objective of this study?

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 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.

Who is eligible to participate?

Inclusion Criteria: 1. Fibrosis index ≥29%, or 2. Evidence of cardiovascular dysfunction including any of the following: - Systemic ejection fraction <55%, - NYHA 2-3 - 6-minute walk distance <500 m. 3. Completion of Visit 1 of the study Heart Failure in Congenital Heart Disease: the role of myocardial fibrosis\" (eIRB # 3665) including meeting all inclusion for that study (Aged 18-80, Known congenital heart disease). 4. Tetralogy of Fallot, cyanotic congenital heart disease, or a systemic right ventricle. Exclusion Criteria: 1. Patient currently taking spironolactone or previously taking spironolactone within the last 6 months. 2. Serum potassium ≥5.0 mmol/L at the initial visit, if not taking potassium supplements. Patients will be eligible if a repeat potassium is <5.0 mmol/L after potassium supplements have been discontinued. 3. Moderate/severe systemic atrioventricular valve regurgitation, 4. Likely to undergo cardiac surgery, pacemaker implantation, or possible transplantation within one year (all self-reported), 5. Unwilling to commit to return visits including mandatory blood draws for potassium, 6. Renal insufficiency (estimated creatinine clearance < 30 ml/min/1.73m2), 7. Positive urine pregnancy test. 8. Any contraindication to MRI.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Congenital Heart Disease

Heart Failure

Endomyocardial Fibrosis

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:SpironolactoneSpironolactone 25 mg daily for 12 months

Other:PlaceboPlacebo daily for 12 months

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Placebo

SpironolactoneSpironolactone 25 mg daily

Study Status

Completed

Start Date: February 2010

Completed Date: March 2017

Phase: Phase 2

Type: Interventional

Design:

Primary Outcome: "Fibrosis Index" or the volume of distribution of gadolinium in the myocardium measured by MRI.

Secondary Outcome: PCIIINP, PCINP, MMP-2, TIMP-1, 6-minute walk distance, ejection fraction, and degree of diastolic function

Study sponsors, principal investigator, and references

Principal Investigator: Craig Broberg, MD

Lead Sponsor: Oregon Health and Science University

Collaborator: National Heart, Lung, and Blood Institute (NHLBI)

More information:https://clinicaltrials.gov/show/NCT01069510

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