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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
  Purpose

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 Intervention
Congenital Heart Disease
Cardiovascular Disease
Procedure: Six minute walk test
Behavioral: Minnesota Living with Heart Failure Questionnaire

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • BNP Levels [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Levels of B-type naturietic peptide in the blood


Enrollment: 34
Study Start Date: December 2001
Study Completion Date: September 2004
Primary Completion Date: March 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00308230

Sponsors and Collaborators
Emory University
Pfizer
Investigators
Principal Investigator: Wendy M Book, M.D. Emory University
  More Information

No publications provided

Responsible Party: Wendy M. Book, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT00308230     History of Changes
Other Study ID Numbers: IRB00045884
Study First Received: March 27, 2006
Results First Received: September 10, 2013
Last Updated: July 16, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Emory University:
Congenital, BNP

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Defects, Congenital
Heart Diseases
Cardiovascular Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on November 25, 2014