Congenital Heart DiseaseNCT00308230
Pilot Study of B-Type Natrieutic Peptide (BNP) Levels in Patients With Congenital Heart Disease(BNP)
A study testing Six minute walk test and Minnesota Living with Heart Failure Questionnaire in people with Congenital Heart Disease and Cardiovascular Disease, run by Emory University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Congenital Heart Disease, Cardiovascular Disease
- What is being tested?
- Six minute walk test and Minnesota Living with Heart Failure Questionnaire
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- Dec 2001to Sep 2004
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
About this study
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
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.
Read the 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.
- Conditions
- Congenital Heart Disease, Cardiovascular Disease
- Being tested
- Six minute walk test, Minnesota Living with Heart Failure Questionnaire
- Keywords
- Congenital, BNP
- Medical subject headings
- Heart Defects, Congenital, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Six minute walk testProcedure or surgery
Minnesota Living with Heart Failure QuestionnaireBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Normal Heart | Placebo comparator | Control Group with Normal Heart Receives: Procedure: Six minute walk test; Behavioral: Minnesota Living with Heart Failure Questionnaire |
| Congenital Heart Disease | Active comparator | Tetralogy of Fallot, DTGA, CCTGA Receives: Procedure: Six minute walk test; Behavioral: Minnesota Living with Heart Failure Questionnaire |
| Heart Failure | Active comparator | Left ventricular heart failure, no congestive heart disease Receives: Procedure: Six minute walk test; Behavioral: Minnesota Living with Heart Failure Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
BNP Levels
Levels of B-type naturietic peptide in the blood
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2006 (estimated)
- Study startDec 2001
- Primary completionMar 2004
- Study completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Wendy M. Book, Emory University
- Investigators
- Wendy M Book, M.D., Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00308230
- Sponsor's protocol ID
- IRB00045884
- Status last verified
- Jul 2014
- First submitted
- 27 Mar 2006
- Last updated
- 17 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00308230
- Acronym / sponsor ID
- IRB00045884
- Conditions
- Congenital Heart Disease, Cardiovascular Disease
- Keywords
- Congenital, BNP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Dec 2001
- Primary completion
- Mar 2004 (actual)
- Study completion
- Sep 2004 (actual)
- First posted
- 29 Mar 2006 (estimated)
- Results
- Posted 17 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal Heart | Placebo comparator | Procedure: Six minute walk test, Behavioral: Minnesota Living with Heart Failure QuestionnaireControl Group with Normal Heart |
| Congenital Heart Disease | Active comparator | Procedure: Six minute walk test, Behavioral: Minnesota Living with Heart Failure QuestionnaireTetralogy of Fallot, DTGA, CCTGA |
| Heart Failure | Active comparator | Procedure: Six minute walk test, Behavioral: Minnesota Living with Heart Failure QuestionnaireLeft ventricular heart failure, no congestive heart disease |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Six minute walk test | Procedure or surgery | Congenital Heart Disease, Heart Failure, Normal Heart |
| Minnesota Living with Heart Failure Questionnaire | Behavioural | Congenital Heart Disease, Heart Failure, Normal Heart |
Primary outcome
BNP Levels
Time frame: 1 day
Levels of B-type naturietic peptide in the blood
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wendy M Book, M.D. principal investigator
Emory University
Questions about this trial
What is this clinical trial studying?
A study testing Six minute walk test and Minnesota Living with Heart Failure Questionnaire in people with Congenital Heart Disease and Cardiovascular Disease, run by Emory University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BNP Levels (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2014.