Right Ventricular Failure in Congenital Heart Defects

NCT00266201 | Completed

• 2 other identifiers: MP 5.101G10210
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 9

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.

Conditions

Heart Failure; Congenital Heart Defects

Keywords

Heart Defects, Congenital; Right Ventricular Dysfunction; Low Cardiac Output; Biochemical markers; Neurohumoral activity

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Competence Network for Congenital Heart Defects: lead
• German Federal Ministry of Education and Research: collaborator

Study Sites (9)

Zentrum fuer Kinderheilkunde und Jugendmedizin

Freiburg im Breisgau, Baden-Wurttemberg, D-79106, Germany

Location

Kinderherzzentrum des Klinikum Stuttgart

Stuttgart, Baden-Wurttemberg, D-70176, Germany

Location

Universitätsklinikum Tuebingen

Tübingen, Baden-Wurttemberg, D-72076, Germany

Location

Herzzentrum Hamburg, UKE

Hamburg, Hamburg, D-29246, Germany

Location

Städtische Kliniken Oldenburg

Oldenburg, Lower Saxony, D-26133, Germany

Location

Herz- und Diabeteszentrum

Bad Oeynhausen, North Rhine-Westphalia, D-32545, Germany

Location

Universitätsklinikum Essen

Essen, North Rhine-Westphalia, D-45122, Germany

Location

Deutsches Kinderherzzentrum

Sankt Augustin, North Rhine-Westphalia, D-53757, Germany

Location

Deutsches Herzzentrum Berlin

Berlin, State of Berlin, D-13353, Germany

Location

Related Publications (1)

• 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.

  PMID: 20981430 DERIVED

MeSH Terms

Conditions

Heart Failure; Heart Defects, Congenital; Ventricular Dysfunction, Right; Cardiac Output, Low

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ventricular Dysfunction; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Brigitte Stiller, MD

  German Heart Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: December 15, 2005
• First Posted: December 16, 2005
• Study Start: June 1, 2003
• Study Completion: July 1, 2006
• Last Updated: August 18, 2011

Record last verified: 2007-04

Locations

DE (9)