Congenital Heart Disease, Cardiovascular Disease
Conditions
Keywords
Congenital, BNP
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.
Interventions
PROCEDURESix minute walk test
Sponsors
Pfizer
Emory University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BNP Levels | 1 day | Levels of B-type naturietic peptide in the blood |
Participant flow
Recruitment details
medical specialty clinic
Pre-assignment details
No washout or run-in period. Participants were stable Ambulatory outpatients with no changes in their medical regimen for prior to enrollment. Exclusions included inability to complete a six minute walk, inability to cooperate with instructions, congenital diagnosis other than the three listed in the CHD group (TOF, DTGA, CCTGA)
Participants by arm
| Arm | Count |
|---|---|
| Control Structurally normal heart without heart disease | 6 |
| Congenital Heart Disease Tetralogy of Fallot, d-transposition of the great arteries, congenitally corrected transposition of the great arteries | 8 |
| Heart Failure Acquired left ventricular heart failure, no history of congenital heart disease | 20 |
| Total | 34 |
Baseline characteristics
| Characteristic | Control | Congenital Heart Disease | Heart Failure | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 8 Participants | 20 Participants | 34 Participants |
| Sex: Female, Male Female | 4 Participants | 3 Participants | 4 Participants | 11 Participants |
| Sex: Female, Male Male | 2 Participants | 5 Participants | 16 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 6 | 0 / 8 | 0 / 20 |
| serious Total, serious adverse events | 0 / 6 | 0 / 8 | 0 / 20 |
Outcome results
Primary
BNP Levels
Levels of B-type naturietic peptide in the blood
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | BNP Levels | 16.3 pg/ml | Standard Deviation 17.3 |
| Congenital Heart Disease | BNP Levels | 42.4 pg/ml | Standard Deviation 44.8 |
| Heart Failure | BNP Levels | 384.3 pg/ml | Standard Deviation 452.8 |