Pilot Study of B-Type Natrieutic Peptide (BNP) Levels in Patients With Congenital Heart Disease(BNP)

Emory University

Status: Completed

Conditions: Congenital Heart Disease; Cardiovascular Disease

Treatments: Behavioral: Minnesota Living with Heart Failure Questionnaire; Procedure: Six minute walk test

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00308230

IRB00045884

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 34 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 3 patient groups, including a placebo group

Normal Heart

Placebo Comparator group

Description:

Control Group with Normal Heart

Treatment:

Procedure: Six minute walk test

Behavioral: Minnesota Living with Heart Failure Questionnaire

Congenital Heart Disease

Active Comparator group

Description:

Tetralogy of Fallot, DTGA, CCTGA

Treatment:

Procedure: Six minute walk test

Behavioral: Minnesota Living with Heart Failure Questionnaire

Heart Failure

Active Comparator group

Description:

Left ventricular heart failure, no congestive heart disease

Treatment:

Procedure: Six minute walk test

Behavioral: Minnesota Living with Heart Failure Questionnaire