Overview

Spironolactone in Adult Congenital Heart Disease

Status:
Completed
Trial end date:
2017-03-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Oregon Health and Science University
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Oregon Clinical and Translational Research Institute
Treatments:
Spironolactone
Criteria
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.