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Investigator left institution
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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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Hypothesis:
By blocking aldosterone signaling in patients with Tetralogy of Fallot, Transposition of the great vessels with a prior atrial switch, and single ventricle "Fontan" patients, incident heart failure will be delayed, symptoms of heart failure ameliorated, and risk of arrhythmias decreased through decreases in myocardial fibrosis.
Half of enrolled patients will complete an SF-36 quality of life questionnaire, perform a 6 minute walk, and have blood drawn for biomarker analysis at enrollment, again after 3 months without therapy, after 6 months on therapy, then finally after 12 months of eplerenone therapy. Half of enrolled patients will have the 3 month drug free period at the end of 12 months on therapy. Patients will be randomly assigned to drug free period up front versus at the conclusion of the trial period. Eplerenone will be started at a dose of 25mg and titrated up to 50mg at 4 weeks if tolerated. Blood will be drawn for basic metabolic panel analysis at enrollment, 3 months, 4 months to allow for dose titration, and at 6 and 12 months for monitoring.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eplerenone after drug free period | Other | Patients will be given eplerenone 50mg for 12 months after an initial 3 month drug free period |
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| Eplerenone before drug free period | Other | Patients will be given eplerenone 50mg for 12 months, followed by a 3 month drug free period |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eplerenone | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Procollagen N-terminal Peptide 1 | Baseline, 6 months and 12 months from eplerenone administration | |
| Procollagen III N-Terminal Peptide | Baseline, 6 months and 12 months from eplerenone administration | |
| Galectin 3 | Baseline, 6 months and 12 months from eplerenone administration |
| Measure | Description | Time Frame |
|---|---|---|
| 6 Minute Walk | Baseline, 6 months, 12 months from eplerenone administration | |
| Quality of Life | Rand 36-item Short Score Physical Domain Scale (SF-36) Range: 0-100, Higher scores suggest better function |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Creatinine | Baseline, 6 months, 12 months from eplerenone administration |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Eplerenone After Drug Free Period | Patients will be given eplerenone 50mg for 12 months after an initial 3 month drug free period Eplerenone |
| FG001 | Eplerenone Before Drug Free Period |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Baseline, 6 months, 12 months from eplerenone administration |
Patients will be given eplerenone 50mg for 12 months, followed by a 3 month drug free period
Eplerenone
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Total Study Group | Crossover study, all patients pooled for baseline analysis |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Tetralogy of Fallot | Count of Participants | Participants |
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| Patients with Transposition of the Great Vessels with a Systemic Right Ventricle (RV) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Procollagen N-terminal Peptide 1 | Outcome analyzed only during the eplerenone period as specified in the protocol | Posted | Mean | Standard Deviation | ug/ml | Baseline, 6 months and 12 months from eplerenone administration |
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| Primary | Procollagen III N-Terminal Peptide | Outcome analyzed only during the eplerenone period as specified in the protocol | Posted | Mean | Standard Deviation | ug/ml | Baseline, 6 months and 12 months from eplerenone administration |
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| Primary | Galectin 3 | Outcome analyzed only during the eplerenone period as specified in the protocol | Posted | Mean | Standard Deviation | ng/ml | Baseline, 6 months and 12 months from eplerenone administration |
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| Secondary | 6 Minute Walk | Outcome analyzed only during the eplerenone period as specified in the protocol | Posted | Mean | Standard Deviation | Feet | Baseline, 6 months, 12 months from eplerenone administration |
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| Secondary | Quality of Life | Rand 36-item Short Score Physical Domain Scale (SF-36) Range: 0-100, Higher scores suggest better function | Outcome analyzed only during the eplerenone period as specified in the protocol | Posted | Mean | Inter-Quartile Range | Score on a scale | Baseline, 6 months, 12 months from eplerenone administration |
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| Other Pre-specified | Serum Creatinine | Outcome analyzed only during the eplerenone period as specified in the protocol | Posted | Mean | Standard Deviation | mg/dl | Baseline, 6 months, 12 months from eplerenone administration |
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During 12 months while on eplerenone
Adverse event data only collected during the eplerenone period
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Eplerenone Period | Change from baseline at time of drug initiation | 0 | 26 | 0 | 26 | 6 | 26 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leg cramping | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| dizziness | Nervous system disorders | Non-systematic Assessment |
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| hyperkalemia | Renal and urinary disorders | Non-systematic Assessment |
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| edema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| chest pain | Cardiac disorders | Non-systematic Assessment |
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| hypotension | Cardiac disorders | Non-systematic Assessment |
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Incomplete study enrollment led to inadequate power to derive reliable conclusions.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ari Cedars | UT Southwestern | 3149224788 | acedars97@gmail.com |
| ID | Term |
|---|---|
| D013771 | Tetralogy of Fallot |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D000077545 | Eplerenone |
| ID | Term |
|---|---|
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| Title | Measurements |
|---|---|
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| Baseline |
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| 6 Months |
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| 12 Months |
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| Baseline |
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| 6 Months |
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| 12 Months |
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| Baseline |
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| 6 Months |
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| 12 Months |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Baseline |
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| 6 Months |
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| 12 Months |
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| Baseline |
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| 6 Months |
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| 12 Months |
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