Clinical trial NCT00266201: Right Ventricular Failure in Congenital Heart Defects
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Congenital Heart Defects
Keywords: Heart Defects, Congenital
Right Ventricular Dysfunction
Low Cardiac Output
Biochemical markers
Neurohumoral activity
Lead sponsor: Competence Network for Congenital Heart Defects
Sponsor class: OTHER_GOV
Collaborators: name: German Federal Ministry of Education and Research
First posted: 2005-12-16
Enrollment: 150
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria

* 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: Zentrum fuer Kinderheilkunde und Jugendmedizin
state: Baden-Wuerttemberg
city: Stuttgart
country: Germany
facility: Kinderherzzentrum des Klinikum Stuttgart
state: Baden-Wuerttemberg
city: Tuebingen
country: Germany
facility: Universitätsklinikum Tuebingen
state: Baden-Wuerttemberg
city: Oldenburg
country: Germany
facility: Städtische Kliniken Oldenburg
state: Lower Saxony
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum
state: North Rhine-Westphalia
city: Essen
country: Germany
facility: Universitätsklinikum Essen
state: North Rhine-Westphalia
city: Sankt Augustin
country: Germany
facility: Deutsches Kinderherzzentrum
state: North Rhine-Westphalia
city: Berlin
country: Germany
facility: Deutsches Herzzentrum Berlin
city: Hamburg
country: Germany
facility: Herzzentrum Hamburg, UKE
Study officials:
affiliation: German Heart Institute
name: Brigitte Stiller, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.