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

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ClinicalTrials.gov Identifier: NCT00308230
Recruitment Status : Completed
First Posted : March 29, 2006
Results First Posted : July 17, 2014
Last Update Posted : July 17, 2014
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Wendy M. Book, Emory University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Congenital Heart Disease Cardiovascular Disease Procedure: Six minute walk test Behavioral: Minnesota Living with Heart Failure Questionnaire Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
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
Study Start Date : December 2001
Actual Primary Completion Date : March 2004
Actual Study Completion Date : September 2004

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. BNP Levels [ Time Frame: 1 day ]
    Levels of B-type naturietic peptide in the blood


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00308230


Sponsors and Collaborators
Emory University
Pfizer
Investigators
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Principal Investigator: Wendy M Book, M.D. Emory University
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Wendy M. Book, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT00308230    
Other Study ID Numbers: IRB00045884
First Posted: March 29, 2006    Key Record Dates
Results First Posted: July 17, 2014
Last Update Posted: July 17, 2014
Last Verified: July 2014
Keywords provided by Wendy M. Book, Emory University:
Congenital, BNP
Additional relevant MeSH terms:
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Cardiovascular Diseases
Heart Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities