Phase 2
Completed N=15
Spironolactone in Adult Congenital Heart Disease
Heart Failure · Endomyocardial Fibrosis
Source: ClinicalTrials.gov NCT01069510 ↗
Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcomePrimary: Extracellular Volume Fraction — 30.1; 25.3 percentage of myocardium
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Extracellular Volume Fraction |
30.1; 25.3 | — |
| SECONDARY 6-minute Walk Distance |
516; 492 | — |
| SECONDARY Procollagen 3 NT Peptide |
3; 4.8 | — |
Eligibility Criteria
Inclusion Criteria
- Fibrosis index ≥29%, or
- Evidence of cardiovascular dysfunction including any of the following:
- Systemic ejection fraction <55%,
- NYHA 2-3
- 6-minute walk distance <500 m.
- 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.
Data sourced from ClinicalTrials.gov (NCT01069510). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.