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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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The object of this study is to measure the levels of B-type Natriuretic Peptide (BNP) in patients with congenital heart disease, normal individuals, and patients with acquired heart failure, and compare the results from each group.
Enrollment: Patients with congenital heart disease seen at Emory Clinics, Adult Congenital Heart Disease program, Crawford Long Hospital will be asked to participate in this pilot study. Sample size: 20 patients (5 in each group) Screening Phase: Demographic data, medical history, physical examination including vital signs and room air oxygen saturation, and medications will be recorded. New York Heart association functional class will be recorded.
BNP Levels: Approximately 7 cc of blood will be collected. The blood will be analyzed for B-type natriuretic peptide on a rapid assay in the clinic.
Exercise Tolerance: will be measured by a 6 minute walk test on day of visit Echocardiogram: A complete echocardiogram including assessment of anatomy, ventricular function and valvular function will be performed following the phlebotomy.
Quality of life: The minnesota living with heart failure questionnaire will be administered on the day of collection of neurohormonal levels. A research nurse will be available to assist the patient if needed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal Heart | Placebo Comparator | Control Group with Normal Heart |
|
| Congenital Heart Disease | Active Comparator | Tetralogy of Fallot, DTGA, CCTGA |
|
| Heart Failure | Active Comparator | Left ventricular heart failure, no congestive heart disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Six minute walk test | Procedure |
| ||
| Minnesota Living with Heart Failure Questionnaire |
| Measure | Description | Time Frame |
|---|---|---|
| BNP Levels | Levels of B-type naturietic peptide in the blood | 1 day |
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Inclusion Criteria:Patients with a systemic right ventricle and a subpulmonic left ventricle-including patients with transposition of the great arteries (d-TGA) who have undergone Mustard and Senning repairs (atrial switch procedures) and patients with congenitally corrected TGA (l-TGA) Subpulmonic right ventricle in the absence of pulmonary hypertension (repaired tetralogy of Fallot, congenital pulmonic regurgitation) 4-chambered heart Age > 18 years Participants will have either acquired left ventricular dysfunction (ejection fraction < 35%) or no known cardiac disease For the control group, individuals will have normal cardiac anatomy and normal left ventricular function (determined by echocardiogram) and no known cardiac disease.
Exclusion Criteria:
Single ventricle and or single atria Liver disease with portal hypertension Renal disease requiring dialysis Creatine > 4.0 Significant pulmonary hypertension (systolic PAP >60 mmHg by Echo) Uncontrolled systemic arterial hypertension (systolic > 200 mmHg or diastolic >105 mmHg) Myocardial infarction or acute coronary syndrome within 2 months D-TGA status post atrial switch procedure (Jatene) Intracardiac shunts Inadequate echocardiogram windows Coronary Angioplasty 30 days
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| Name | Affiliation | Role |
|---|---|---|
| Wendy M Book, M.D. | Emory University | Principal Investigator |
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No washout or run-in period. Participants were stable Ambulatory outpatients with no changes in their medical regimen for prior to enrollment.
Exclusions included inability to complete a six minute walk, inability to cooperate with instructions, congenital diagnosis other than the three listed in the CHD group (TOF, DTGA, CCTGA)
medical specialty clinic
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | Structurally normal heart without heart disease. |
| FG001 | Congenital Heart Disease | Tetralogy of Fallot, d-transposition of the great arteries, congenitally corrected transposition of the great arteries |
| FG002 | Heart Failure | Acquired left ventricular heart failure, no history of congenital heart disease |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Structurally normal heart without heart disease |
| BG001 | Congenital Heart Disease | Tetralogy of Fallot, d-transposition of the great arteries, congenitally corrected transposition of the great arteries |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | BNP Levels | Levels of B-type naturietic peptide in the blood | Posted | Mean | Standard Deviation | pg/ml | 1 day |
|
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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 | Control Group | Structurally normal heart without heart disease |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wendy Book | Emory University | 404-778-5545 | wbook@emory.edu |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| Behavioral |
|
| BG002 | Heart Failure | Acquired left ventricular heart failure, no history of congenital heart disease |
| BG003 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
|
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| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Congenital Heart Disease | Tetralogy of Fallot, d-transposition of the great arteries, congenitally corrected transposition of the great arteries | 0 | 8 | 0 | 8 |
| EG002 | Heart Failure | Acquired left ventricular heart failure, no history of congenital heart disease | 0 | 20 | 0 | 20 |
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