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| ID | Type | Description | Link |
|---|---|---|---|
| K23HL093024-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| Oregon Clinical and Translational Research Institute | OTHER |
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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 also have visits 3-6 weeks, 3, 6, 9 months, and 12 months after randomization. Visits 2-5 will include the following:
Visit 6 will be identical to visit 1 and include the following:
The investigators will compare the study drug, called spironolactone, to placebo with regard to any changes in heart stiffening and function of the heart.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Patients will receive placebo |
|
| Spironolactone | Experimental | Spironolactone 25 mg daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spironolactone 25mg | Drug | Spironolactone 25 mg daily for 12 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Extracellular Volume Fraction | extracellular volume fraction measured by T1 mapping with MRI | 12 month |
| Measure | Description | Time Frame |
|---|---|---|
| 6-minute Walk Distance | distance walked recorded in meters after 6 minutes on flat ground | 12 month |
| Procollagen 3 NT Peptide | 12 months |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Craig Broberg, MD | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
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Recruited at time of presentation for larger study. However, most did not meet enrollment criteria and could not be randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Patients will receive placebo Placebo: Placebo daily for 12 months |
| FG001 | Spironolactone | Spironolactone 25 mg daily Spironolactone 25mg: Spironolactone 25 mg daily for 12 months |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Patients will receive placebo Placebo: Placebo daily for 12 months |
| BG001 | Spironolactone | Spironolactone 25 mg daily Spironolactone 25mg: Spironolactone 25 mg daily for 12 months |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Extracellular Volume Fraction | extracellular volume fraction measured by T1 mapping with MRI | Posted | Mean | Standard Deviation | percentage of myocardium | 12 month |
|
|
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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 | Placebo | Patients will receive placebo Placebo: Placebo daily for 12 months |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Craig Broberg | Oregon Health and Science Univ. | 503-494-7400 | brobergc@ohsu.edu |
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| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D006333 | Heart Failure |
| D004719 | Endomyocardial Fibrosis |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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| ID | Term |
|---|---|
| D013148 | Spironolactone |
| ID | Term |
|---|---|
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 |
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| Placebo | Other | Placebo daily for 12 months |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Secondary | 6-minute Walk Distance | distance walked recorded in meters after 6 minutes on flat ground | Posted | Mean | Standard Deviation | meters | 12 month |
|
|
|
| Secondary | Procollagen 3 NT Peptide | Limited samples obtained from participants | Posted | Mean | Standard Deviation | mcg/l | 12 months |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Spironolactone | Spironolactone 25 mg daily Spironolactone 25mg: Spironolactone 25 mg daily for 12 months | 0 | 7 | 0 | 7 |
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| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D009202 | Cardiomyopathies |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |