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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Emory University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Pfizer
Information provided by:
Emory University
ClinicalTrials.gov Identifier:
NCT00308230
First received: March 27, 2006
Last updated: June 2, 2009
Last verified: June 2009
History of Changes
  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
 Other: Blood Draws -BNP sample

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:

U.S. FDA Resources

Further study details as provided by Emory University:

Primary Outcome Measures:
  • Prognosis, Do BNP levels correlate with degree of heart failure? [ Time Frame: Ongoing ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: December 2001
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Blood Draws -BNP sample
    Blood draws for BNP samples
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00308230

Locations
United States, Georgia
Emory Adult Congenital Heart Center, The Emory Clinic, Bldg A., 2nd Floor, 1365 Clifton Road, NE
Atlanta, Georgia, United States, 30322
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, MD, Emory University
ClinicalTrials.gov Identifier: NCT00308230     History of Changes
Other Study ID Numbers: 625-2001
Study First Received: March 27, 2006
Last Updated: June 2, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Emory University:
Congenital, BNP

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities
Natriuretic Peptide, Brain
 Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013