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

NCT ID: NCT00308230

Last Updated: 2014-07-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-12-31

Study Completion Date

2004-09-30

Brief Summary

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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

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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.

Conditions

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Congenital Heart Disease Cardiovascular Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Normal Heart

Control Group with Normal Heart

Group Type PLACEBO_COMPARATOR

Six minute walk test

Intervention Type PROCEDURE

Minnesota Living with Heart Failure Questionnaire

Intervention Type BEHAVIORAL

Congenital Heart Disease

Tetralogy of Fallot, DTGA, CCTGA

Group Type ACTIVE_COMPARATOR

Six minute walk test

Intervention Type PROCEDURE

Minnesota Living with Heart Failure Questionnaire

Intervention Type BEHAVIORAL

Heart Failure

Left ventricular heart failure, no congestive heart disease

Group Type ACTIVE_COMPARATOR

Six minute walk test

Intervention Type PROCEDURE

Minnesota Living with Heart Failure Questionnaire

Intervention Type BEHAVIORAL

Interventions

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Six minute walk test

Intervention Type PROCEDURE

Minnesota Living with Heart Failure Questionnaire

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

Emory University

OTHER

Sponsor Role lead

Responsible Party

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Wendy M. Book

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wendy M Book, M.D.

Role: PRINCIPAL_INVESTIGATOR

Emory University

Other Identifiers

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IRB00045884

Identifier Type: -

Identifier Source: org_study_id

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