CompletedPhase 2

Spironolactone in Adult Congenital Heart Disease

United States40 participantsStarted 2010-02

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. Fibrosis index ≥29%, or
✓. Evidence of cardiovascular dysfunction including any of the following:
✓. 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).
✓. Tetralogy of Fallot, cyanotic congenital heart disease, or a systemic right ventricle.

Exclusion criteria

✕. Patient currently taking spironolactone or previously taking spironolactone within the last 6 months.
✕. 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.
✕. Moderate/severe systemic atrioventricular valve regurgitation,
✕. Likely to undergo cardiac surgery, pacemaker implantation, or possible transplantation within one year (all self-reported),
✕. Unwilling to commit to return visits including mandatory blood draws for potassium,
✕. Renal insufficiency (estimated creatinine clearance \< 30 ml/min/1.73m2),
✕. Positive urine pregnancy test.
✕. Any contraindication to MRI.

What they're measuring

Extracellular Volume Fraction

Timeframe: 12 month

Trial details

NCT IDNCT01069510

SponsorOregon Health and Science University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-06

Results submitted2019-07-30

View on ClinicalTrials.gov More Congenital Heart Disease trials