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

Cardiovascular Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00308230
• Other study ID #: IRB00045884
• Status: Completed
• Phase: N/A
• First received: March 27, 2006
• Last updated: July 16, 2014
• Start date: December 2001
• Est. completion date: September 2004

Study information

• Verified date: July 2014
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: September 2004
• Est. primary completion date: March 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 89 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Intervention

Procedure:
• Six minute walk test

Behavioral:
• Minnesota Living with Heart Failure Questionnaire

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BNP Levels	Levels of B-type naturietic peptide in the blood	1 day	No