Right Ventricular Failure in Congenital Heart Defects

Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00266201
• Other study ID #: MP 5.1
• Secondary ID: 01G10210
• Status: Completed
• Phase: N/A
• First received: December 15, 2005
• Last updated: August 17, 2011
• Start date: June 2003
• Est. completion date: July 2006

Study information

• Verified date: April 2007
• Source: Competence Network for Congenital Heart Defects
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: July 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 14 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Congenital Heart Defects
• Heart Defects, Congenital
• Heart Failure

Locations

Country	Name	City	State
Germany	Herz- und Diabeteszentrum	Bad Oeynhausen	North Rhine-Westphalia
Germany	Deutsches Herzzentrum Berlin	Berlin
Germany	Universitätsklinikum Essen	Essen	North Rhine-Westphalia
Germany	Zentrum fuer Kinderheilkunde und Jugendmedizin	Freiburg	Baden-Wuerttemberg
Germany	Herzzentrum Hamburg, UKE	Hamburg
Germany	Städtische Kliniken Oldenburg	Oldenburg	Lower Saxony
Germany	Deutsches Kinderherzzentrum	Sankt Augustin	North Rhine-Westphalia
Germany	Kinderherzzentrum des Klinikum Stuttgart	Stuttgart	Baden-Wuerttemberg
Germany	Universitätsklinikum Tuebingen	Tuebingen	Baden-Wuerttemberg

Sponsors (2)

Lead Sponsor	Collaborator
Competence Network for Congenital Heart Defects	German Federal Ministry of Education and Research

Country where clinical trial is conducted

Germany,