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

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Disease; Congenital Heart Disease
• Intervention / Treatment: Procedure: Six minute walk test; Behavioral: Minnesota Living with Heart Failure Questionnaire

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Normal Heart; Control Group with Normal Heart	Procedure: Six minute walk test; Behavioral: Minnesota Living with Heart Failure Questionnaire
Active Comparator: Congenital Heart Disease; Tetralogy of Fallot, DTGA, CCTGA	Procedure: Six minute walk test; Behavioral: Minnesota Living with Heart Failure Questionnaire
Active Comparator: Heart Failure; Left ventricular heart failure, no congestive heart disease	Procedure: Six minute walk test; Behavioral: Minnesota Living with Heart Failure Questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BNP Levels	Levels of B-type naturietic peptide in the blood	1 day

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: Pfizer
• Investigators: Principal Investigator: Wendy M Book, M.D., Emory University

Study record dates

Study Major Dates

• Study Start: December 1, 2001
• Primary Completion (Actual): March 1, 2004
• Study Completion (Actual): September 1, 2004

Study Registration Dates

• First Submitted: March 27, 2006
• First Submitted That Met QC Criteria: March 27, 2006
• First Posted (Estimate): March 29, 2006

Study Record Updates

• Last Update Posted (Estimate): July 17, 2014
• Last Update Submitted That Met QC Criteria: July 16, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: Congenital, BNP
• Additional Relevant MeSH Terms: Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Cardiovascular Diseases; Heart Defects, Congenital
• Other Study ID Numbers: IRB00045884