Right Ventricular Failure in Congenital Heart Defects

August 17, 2011 updated by: Competence Network for Congenital Heart Defects

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, D-13353
        • Deutsches Herzzentrum Berlin
      • Hamburg, Germany, D-29246
        • Herzzentrum Hamburg, UKE
    • Baden-Wuerttemberg
      • Freiburg, Baden-Wuerttemberg, Germany, D-79106
        • Zentrum fuer Kinderheilkunde und Jugendmedizin
      • Stuttgart, Baden-Wuerttemberg, Germany, D-70176
        • Kinderherzzentrum des Klinikum Stuttgart
      • Tuebingen, Baden-Wuerttemberg, Germany, D-72076
        • Universitätsklinikum Tuebingen
    • Lower Saxony
      • Oldenburg, Lower Saxony, Germany, D-26133
        • Städtische Kliniken Oldenburg
    • North Rhine-Westphalia
      • Bad Oeynhausen, North Rhine-Westphalia, Germany, D-32545
        • Herz- und Diabeteszentrum
      • Essen, North Rhine-Westphalia, Germany, D-45122
        • Universitatsklinikum Essen
      • Sankt Augustin, North Rhine-Westphalia, Germany, D-53757
        • Deutsches Kinderherzzentrum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Competence Network for Congenital Heart Defects

Collaborators

German Federal Ministry of Education and Research

Investigators

  • Principal Investigator: Brigitte Stiller, MD, German Heart Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Study Completion (Actual)

July 1, 2006

Study Registration Dates

First Submitted

December 15, 2005

First Submitted That Met QC Criteria

December 15, 2005

First Posted (Estimate)

December 16, 2005

Study Record Updates

Last Update Posted (Estimate)

August 18, 2011

Last Update Submitted That Met QC Criteria

August 17, 2011

Last Verified

April 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MP 5.1
  • 01G10210

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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