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| Sponsors and Collaborators: |
Emory University Pfizer |
|---|---|
| Information provided by: | Emory University |
| ClinicalTrials.gov Identifier: | NCT00308230 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Congenital Heart Disease Cardiovascular Disease |
Procedure: Blood Draws -BNP sample |
| Study Type: | Interventional |
| Study Design: | Health Services Research, Non-Randomized, Open Label, Historical Control, Single Group Assignment |
| Official Title: | A Pilot Study of B-Type Natriuretic Peptide (BNP) Levels in Patients With Congenital Heart Disease and Systemic Right Ventricles or Volume Overloaded Pulmonic Right Ventricles |
| Estimated Enrollment: | 100 |
| Study Start Date: | December 2001 |
| Estimated Study Completion Date: | July 2008 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 89 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| Contact: Teresa Lyle, ANP | 404-778-5093 |
| United States, Georgia | |
| Emory University Hospital | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Principal Investigator: Wendy M Book, M.D. | |
| Sub-Investigator: Michael McConnell, M.D. | |
| Principal Investigator: | Wendy M Book, M.D. | Emory University |
More Information
| Study ID Numbers: | 625-2001 |
| Study First Received: | March 27, 2006 |
| Last Updated: | October 30, 2007 |
| ClinicalTrials.gov Identifier: | NCT00308230 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Congenital, BNP |
|
Natriuretic Peptide, Brain Heart Diseases Cardiovascular Abnormalities |
Cardiovascular Agents Congenital Abnormalities Heart Defects, Congenital |
|
Natriuretic Peptide, Brain Heart Diseases Cardiovascular Abnormalities Natriuretic Agents Therapeutic Uses Physiological Effects of Drugs |
Cardiovascular Diseases Cardiovascular Agents Congenital Abnormalities Heart Defects, Congenital Pharmacologic Actions |
