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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Wendy M. Book, Emory University
ClinicalTrials.gov Identifier:
NCT00308230
First received: March 27, 2006
Last updated: July 16, 2014
Last verified: July 2014

March 27, 2006
July 16, 2014
December 2001
March 2004   (final data collection date for primary outcome measure)
BNP Levels [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Levels of B-type naturietic peptide in the blood
Not Provided
Complete list of historical versions of study NCT00308230 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
  • Congenital Heart Disease
  • Cardiovascular Disease
  • Procedure: Six minute walk test
  • Behavioral: Minnesota Living with Heart Failure Questionnaire
  • Placebo Comparator: Normal Heart
    Control Group with Normal Heart
    Interventions:
    • Procedure: Six minute walk test
    • Behavioral: Minnesota Living with Heart Failure Questionnaire
  • Active Comparator: Congenital Heart Disease
    Tetralogy of Fallot, DTGA, CCTGA
    Interventions:
    • Procedure: Six minute walk test
    • Behavioral: Minnesota Living with Heart Failure Questionnaire
  • Active Comparator: Heart Failure
    Left ventricular heart failure, no congestive heart disease
    Interventions:
    • Procedure: Six minute walk test
    • Behavioral: Minnesota Living with Heart Failure Questionnaire
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
September 2004
March 2004   (final data collection date for primary outcome measure)

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

Both
18 Years to 89 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00308230
IRB00045884
No
Wendy M. Book, Emory University
Emory University
Pfizer
Principal Investigator: Wendy M Book, M.D. Emory University
Emory University
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP