Trial record 2 of 649 for:    "Heart Defects, Congenital"

Right Ventricular Failure in Congenital Heart Defects

This study has been completed.
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by:
Competence Network for Congenital Heart Defects
ClinicalTrials.gov Identifier:
NCT00266201
First received: December 15, 2005
Last updated: August 17, 2011
Last verified: April 2007
  Purpose

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
Heart Failure
Congenital Heart Defects

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Competence Network for Congenital Heart Defects:

Estimated Enrollment: 150
Study Start Date: June 2003
Study Completion Date: July 2006
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

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00266201

Locations
Germany
Zentrum fuer Kinderheilkunde und Jugendmedizin
Freiburg, Baden-Wuerttemberg, Germany, D-79106
Kinderherzzentrum des Klinikum Stuttgart
Stuttgart, Baden-Wuerttemberg, Germany, D-70176
Universitätsklinikum Tuebingen
Tuebingen, Baden-Wuerttemberg, Germany, D-72076
Städtische Kliniken Oldenburg
Oldenburg, Lower Saxony, Germany, D-26133
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
Deutsches Herzzentrum Berlin
Berlin, Germany, D-13353
Herzzentrum Hamburg, UKE
Hamburg, Germany, D-29246
Sponsors and Collaborators
Competence Network for Congenital Heart Defects
German Federal Ministry of Education and Research
Investigators
Principal Investigator: Brigitte Stiller, MD German Heart Institute
  More Information

No publications provided by Competence Network for Congenital Heart Defects

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00266201     History of Changes
Other Study ID Numbers: MP 5.1, 01G10210
Study First Received: December 15, 2005
Last Updated: August 17, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by Competence Network for Congenital Heart Defects:
Heart Defects, Congenital
Right Ventricular Dysfunction
Low Cardiac Output
Biochemical markers
Neurohumoral activity

Additional relevant MeSH terms:
Heart Defects, Congenital
Heart Failure
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on August 28, 2014