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Clinical Trials/NCT00308230
NCT00308230
Completed
Not Applicable

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

Emory University0 sites34 target enrollmentDecember 2001

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Congenital Heart Disease
Sponsor
Emory University
Enrollment
34
Primary Endpoint
BNP Levels
Status
Completed
Last Updated
11 years ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
December 2001
End Date
September 2004
Last Updated
11 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Wendy M. Book

Principal Investigator

Emory University

Eligibility 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

Outcomes

Primary Outcomes

BNP Levels

Time Frame: 1 day

Levels of B-type naturietic peptide in the blood

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