Heart FailureNCT00266201
Right Ventricular Failure in Congenital Heart Defects
An observational study of Heart Failure and Congenital Heart Defects, run by Competence Network for Congenital Heart Defects at 9 sites in Germany.
Trial summary
Usually, "heart failure" refers to myocardial insufficiency of the left ventricle. However, in patients with congenital heart defects, often predominantly the right ventricle is affected. Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure, Congenital Heart Defects
- How many people
- 150 participants
- Where
- 9 sitesGermany
- Study dates
- Jun 2003to Jul 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
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 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patient group: - Adolescents (at least14 years old)/adults with a surgically treated congenital heart Control group: - Healthy population, comparable to the patient sample with respect to age and gender
Who may be able to join
- Patient group:
- Adolescents (at least14 years old)/adults with a surgically treated congenital heart defect that leads to stress of the right ventricle
- Consent of the patient, in the case of minors additional consent of the parents or the legal representative, to participation in the study.
- Control group:
- Healthy population, comparable to the patient sample with respect to age and gender
- No heart defect, normal echocardiogram, ECG and MRI
- Consent of the test person, in case of minors additional consent of the parents or the legal representative, to participation
Who cannot join
- Other clinically significant illnesses (e.g. malignant disease, impaired thyroid function)
- Morphological right ventricle as systemic ventricle
- Haemodynamically relevant left ventricular failure
- Treatment with a beta blocker
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Germany9 sites
Herz- und Diabeteszentrum
Bad Oeynhausen, North Rhine-Westphalia, D-32545
Deutsches Herzzentrum Berlin
Berlin, State of Berlin, D-13353
Universitätsklinikum Essen
Essen, North Rhine-Westphalia, D-45122
Zentrum fuer Kinderheilkunde und Jugendmedizin
Freiburg im Breisgau, Baden-Wurttemberg, D-79106
Herzzentrum Hamburg, UKE
Hamburg, Free and Hanseatic City of Hamburg, D-29246
Städtische Kliniken Oldenburg
Oldenburg, Lower Saxony, D-26133
Deutsches Kinderherzzentrum
Sankt Augustin, North Rhine-Westphalia, D-53757
Kinderherzzentrum des Klinikum Stuttgart
Stuttgart, Baden-Wurttemberg, D-70176
Universitätsklinikum Tuebingen
Tübingen, Baden-Wurttemberg, D-72076
About this study
Official title: Evaluation of Biochemical Markers of Neurohumoral Activity and Correlation With Clinically Significant Parameters in Patients With Right Ventricular Failure and Congenital Heart Defects
Usually, "heart failure" refers to myocardial insufficiency of the left ventricle. However, in patients with congenital heart defects, often predominantly the right ventricle is affected.
Brain natriuretic peptide (BNP) has been shown to be a reliable biomarker for left ventricular function and severity of left ventricular failure.
The objective of the present investigation is to evaluate brain natriuretic peptide (BNP) with regard to its predictive value as a biomarker for right ventricular function, clinical symptoms and/or the patients' quality of life.To this end, blood levels of neurohumoral markers are measured and tested for statistical correlation with exercise tolerance and right ventricular function, as assessed by imaging methods. A sample of healthy volunteers serves as a control group.
Read the detailed description
Usually, "heart failure" refers to myocardial insufficiency of the left ventricle. In patients with congenital heart defects, predominantly the right ventricle and secondarily the right atrium and the pulmonary vasculature are affected. Due to advancing treatment options and the resulting higher life expectancy of patients with congenital heart defects, the number of these patients is increasing steadily. As, for these patients, right ventricular failure often is the factor limiting quality of life and life-span, evidence based drug treatment is both clinically important and of relevance with respect to health policy and health economics.
Concerning left ventricular failure, large controlled and randomised studies in the past years have provided evidence that treatment with beta-adrenergic blockers improves the systolic left ventricular function and decreases mortality in cases of left ventricular failure. These therapeutic achievements corroborated the hypothesis that stimulation of the neurohumoral, particularly the noradrenergic, system is a pathophysiological mechanism significant for the development of left ventricular failure.
Large studies demonstrated that brain natriuretic peptide (BNP) is a sensitive biomarker for activation of the noradrenergic system. Plasma levels of BNP closely correlate with the severity of left ventricular failure, qualifying BNP also as a marker of success/failure of treatment.
If right ventricular dysfunction also involves stimulation of the neurohumoral axis, it is conceivable that BNP in this condition also is a sensitive biomarker for activation of the noradregergic system. Under this condition BNP levels might also serve as a predictive marker for clinical outcome and success/failure of therapy as well.
The objective of the present investigation is to assess the predictive value of BNP as a biomarker for right ventricular function, clinical symptoms and/or the patients' quality of life. For this purpose, blood levels of neurohumoral markers are measured and tested for statistical correlation with exercise tolerance and right ventricular function, as assessed by imaging methods. A sample of healthy volunteers serves as a control group.
- Conditions
- Heart Failure, Congenital Heart Defects
- Keywords
- Heart Defects, Congenital, Right Ventricular Dysfunction, Low Cardiac Output, Biochemical markers, Neurohumoral activity
- Medical subject headings
- Heart Failure, Heart Defects, Congenital, Ventricular Dysfunction, Right, Cardiac Output, Low
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2005 (estimated)
- Study startJun 2003
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants
Sponsor and investigators
- Lead sponsor
- Competence Network for Congenital Heart Defects
- Sponsor type
- Other government
- Collaborators
- German Federal Ministry of Education and Research
- Investigators
- Brigitte Stiller, MD, Principal investigator, German Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00266201
- Sponsor's protocol ID
- MP 5.1
- Other IDs
- 01G10210
- Status last verified
- Apr 2007
- First submitted
- 15 Dec 2005
- Last updated
- 18 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Lemmer J, Heise G, Rentzsch A, Boettler P, Kuehne T, Dubowy KO, Peters B, Lemmer B, Hager A, Stiller B; German Competence Network for Congenital Heart Defects. Right ventricular function in grown-up patients after correction of congenital right heart disease. Clin Res Cardiol. 2011 Apr;100(4):289-96. doi: 10.1007/s00392-010-0241-8. Epub 2010 Oct 28.
PubMed 20981430
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Biochemical Markers of Neurohumoral Activity and Correlation With Clinically Significant Parameters in Patients With Right Ventricular Failure and Congenital Heart Defects
- ClinicalTrials.gov ID
- NCT00266201
- Acronym / sponsor ID
- MP 5.1
- Conditions
- Heart Failure, Congenital Heart Defects
- Keywords
- Heart Defects, Congenital, Right Ventricular Dysfunction, Low Cardiac Output, Biochemical markers, Neurohumoral activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants
- Lead sponsor
- Competence Network for Congenital Heart DefectsOther government
- Collaborators
- German Federal Ministry of Education and Research
- Study start
- Jun 2003
- Study completion
- Jul 2006 (actual)
- First posted
- 16 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Usually, "heart failure" refers to myocardial insufficiency of the left ventricle. However, in patients with congenital heart defects, often predominantly the right ventricle is affected.
Brain natriuretic peptide (BNP) has been shown to be a reliable biomarker for left ventricular function and severity of left ventricular failure.
The objective of the present investigation is to evaluate brain natriuretic peptide (BNP) with regard to its predictive value as a biomarker for right ventricular function, clinical symptoms and/or the patients' quality of life.To this end, blood levels of neurohumoral markers are measured and tested for statistical correlation with exercise tolerance and right ventricular function, as assessed by imaging methods. A sample of healthy volunteers serves as a control group.
Detailed description
Usually, "heart failure" refers to myocardial insufficiency of the left ventricle. In patients with congenital heart defects, predominantly the right ventricle and secondarily the right atrium and the pulmonary vasculature are affected. Due to advancing treatment options and the resulting higher life expectancy of patients with congenital heart defects, the number of these patients is increasing steadily. As, for these patients, right ventricular failure often is the factor limiting quality of life and life-span, evidence based drug treatment is both clinically important and of relevance with respect to health policy and health economics.
Concerning left ventricular failure, large controlled and randomised studies in the past years have provided evidence that treatment with beta-adrenergic blockers improves the systolic left ventricular function and decreases mortality in cases of left ventricular failure. These therapeutic achievements corroborated the hypothesis that stimulation of the neurohumoral, particularly the noradrenergic, system is a pathophysiological mechanism significant for the development of left ventricular failure.
Large studies demonstrated that brain natriuretic peptide (BNP) is a sensitive biomarker for activation of the noradrenergic system. Plasma levels of BNP closely correlate with the severity of left ventricular failure, qualifying BNP also as a marker of success/failure of treatment.
If right ventricular dysfunction also involves stimulation of the neurohumoral axis, it is conceivable that BNP in this condition also is a sensitive biomarker for activation of the noradregergic system. Under this condition BNP levels might also serve as a predictive marker for clinical outcome and success/failure of therapy as well.
The objective of the present investigation is to assess the predictive value of BNP as a biomarker for right ventricular function, clinical symptoms and/or the patients' quality of life. For this purpose, blood levels of neurohumoral markers are measured and tested for statistical correlation with exercise tolerance and right ventricular function, as assessed by imaging methods. A sample of healthy volunteers serves as a control group.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient group: - Adolescents (at least14 years old)/adults with a surgically treated congenital heart Control group: - Healthy population, comparable to the patient sample with respect to age and gender
Key inclusion criteria (7 listed)
- Adolescents (at least14 years old)/adults with a surgically treated congenital heart defect that leads to stress of the right ventricle
- Consent of the patient, in the case of minors additional consent of the parents or the legal representative, to participation in the study.
- Healthy population, comparable to the patient sample with respect to age and gender
- No heart defect, normal echocardiogram, ECG and MRI
- Consent of the test person, in case of minors additional consent of the parents or the legal representative, to participation
Key exclusion criteria (4 listed)
- Other clinically significant illnesses (e.g. malignant disease, impaired thyroid function)
- Morphological right ventricle as systemic ventricle
- Haemodynamically relevant left ventricular failure
- Treatment with a beta blocker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2011.
- Derived from this study: PubMed 20981430Lemmer J, Heise G, Rentzsch A, Boettler P, Kuehne T, Dubowy KO, Peters B, Lemmer B, Hager A, Stiller B; German Competence Network for Congenital Heart Defects. Right ventricular function in grown-up patients after correction of congenital right heart disease. Clin Res Cardiol. 2011 Apr;100(4):289-96. doi: 10.1007/s00392-010-0241-8. Epub 2010 Oct 28.
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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.
Brigitte Stiller, MD principal investigator
German Heart Institute
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Congenital Heart Defects, run by Competence Network for Congenital Heart Defects at 9 sites in Germany.
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 7 inclusion and 4 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 18 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00266201, which also lists 1 linked publication.
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 18 Aug 2011.