HP 5.1 Right ventricular failure: observational study (recruitment closed)
Study protocol
The first part of the study on right ventricular failure is a prospective, multi-centric, cross-sectional study. Parametric data are obtained through clinical tests and in the chemical laboratory on patients aged 14 and over with a congenital heart defect and right heart dysfunction. The findings are compared with data obtained from healthy subjects.
A thorough examination of the patient is carried out during an outpatient visit, which includes a physical examination, extensive echocardiography procedures, normal and prolonged ECG tests, a cardiac MRI, exercise testing and blood tests.
No other outpatient visits or drug-based interventions are planned for this first part of the study. In the second part of the study (currently in the planning phase), it is planned to administer a drug-based therapy of beta blockers (based on the example of the treatment for left cardiac insufficiency).
Eligibility
The study is open to patients with a surgically corrected congenital heart defect accompanied by increased pressure on or a dysfunction of the right ventricle, for example patients who have undergone corrective surgery for Tetralogy of Fallot or pulmonary valve atresia. The study is being carried out in Germany on a nation-wide basis in clinics co-operating with the competence network. This means that the patients’ outpatient visits can take place at a location close to home, usually in the heart centre that they normally attend for treatment.
Recruitment of patients
Recruitment of patients for the first, observational, part of the study was closed in April 2006.
Participants
A number of clinics and heart centres all over Germany are taking part in the study. An up-to-date list of these participants can be found here …
Contact
Universitätsklinikum Freiburg
Klinik für Angeborene Herzfehler/Pädiatrische Kardiologie
Mathildenstr. 1
79106 Freiburg
Tel.: +49 761 2704323
Fax: +49 761 2704468
E-Mail: brigitte.stiller(at)uniklinik-freiburg.de

