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Sponsors and Collaborators: |
Competence Network for Congenital Heart Defects German Federal Ministry of Education and Research |
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Information provided by: | Competence Network for Congenital Heart Defects |
ClinicalTrials.gov Identifier: | NCT00266201 |
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.
Condition |
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Heart Failure Congenital Heart Defects |
Study Type: | Observational |
Study Design: | Screening, Cross-Sectional, Defined Population, Prospective 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 |
Estimated Enrollment: | 150 |
Study Start Date: | June 2003 |
Study Completion Date: | July 2006 |
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.
Ages Eligible for Study: | 14 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Patient group:
Control group:
Exclusion Criteria
Germany | |
Deutsches Herzzentrum Berlin | |
Berlin, Germany, D-13353 | |
Herzzentrum Hamburg, UKE | |
Hamburg, Germany, D-29246 | |
Germany, Baden-Wuerttemberg | |
Kinderherzzentrum des Klinikum Stuttgart | |
Stuttgart, Baden-Wuerttemberg, Germany, D-70176 | |
Universitätsklinikum Tuebingen | |
Tuebingen, Baden-Wuerttemberg, Germany, D-72076 | |
Zentrum fuer Kinderheilkunde und Jugendmedizin | |
Freiburg, Baden-Wuerttemberg, Germany, D-79106 | |
Germany, Lower Saxony | |
Städtische Kliniken Oldenburg | |
Oldenburg, Lower Saxony, Germany, D-26133 | |
Germany, North Rhine-Westphalia | |
Herz- und Diabeteszentrum | |
Bad Oeynhausen, North Rhine-Westphalia, Germany, D-32545 | |
Universitätsklinikum Essen | |
Essen, North Rhine-Westphalia, Germany, D-45122 | |
Deutsches Kinderherzzentrum | |
Sankt Augustin, North Rhine-Westphalia, Germany, D-53757 |
Principal Investigator: | Brigitte Stiller, MD | German Heart Institute |
Study ID Numbers: | MP 5.1, 01G10210 |
Study First Received: | December 15, 2005 |
Last Updated: | April 5, 2007 |
ClinicalTrials.gov Identifier: | NCT00266201 |
Health Authority: | Germany: Ethics Commission |
Heart Defects, Congenital Right Ventricular Dysfunction Low Cardiac Output Biochemical markers Neurohumoral activity |
Ventricular Dysfunction Heart Failure Heart Diseases Cardiovascular Abnormalities |
Ventricular Dysfunction, Right Congenital Abnormalities Heart Defects, Congenital Cardiac Output, Low |
Cardiovascular Diseases |