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

Primary Purpose

Congenital Heart Disease, Cardiovascular Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Six minute walk test
Minnesota Living with Heart Failure Questionnaire
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Congenital Heart Disease focused on measuring Congenital, BNP

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Placebo Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Normal Heart

    Congenital Heart Disease

    Heart Failure

    Arm Description

    Control Group with Normal Heart

    Tetralogy of Fallot, DTGA, CCTGA

    Left ventricular heart failure, no congestive heart disease

    Outcomes

    Primary Outcome Measures

    BNP Levels
    Levels of B-type naturietic peptide in the blood

    Secondary Outcome Measures

    Full Information

    First Posted
    March 27, 2006
    Last Updated
    July 16, 2014
    Sponsor
    Emory University
    Collaborators
    Pfizer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00308230
    Brief Title
    Pilot Study of B-Type Natrieutic Peptide (BNP) Levels in Patients With Congenital Heart Disease(BNP)
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2001 (undefined)
    Primary Completion Date
    March 2004 (Actual)
    Study Completion Date
    September 2004 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Emory University
    Collaborators
    Pfizer

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Congenital Heart Disease, Cardiovascular Disease
    Keywords
    Congenital, BNP

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    34 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Normal Heart
    Arm Type
    Placebo Comparator
    Arm Description
    Control Group with Normal Heart
    Arm Title
    Congenital Heart Disease
    Arm Type
    Active Comparator
    Arm Description
    Tetralogy of Fallot, DTGA, CCTGA
    Arm Title
    Heart Failure
    Arm Type
    Active Comparator
    Arm Description
    Left ventricular heart failure, no congestive heart disease
    Intervention Type
    Procedure
    Intervention Name(s)
    Six minute walk test
    Intervention Type
    Behavioral
    Intervention Name(s)
    Minnesota Living with Heart Failure Questionnaire
    Primary Outcome Measure Information:
    Title
    BNP Levels
    Description
    Levels of B-type naturietic peptide in the blood
    Time Frame
    1 day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    89 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Wendy M Book, M.D.
    Organizational Affiliation
    Emory University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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