Cardiac imaging under dobutamine stress for early assessment of right ventricular function in patients with tetralogy of Fallot and pulmonary regurgitation - Fallot-stress

• Conditions: Fallot tetralogy late after repair with marked pulmonary valve incompetence

• Registration Number: EUCTR2007-003461-41-DE
• Lead Sponsor: Deutsche Herzzentrum Berlin, Kompetenznetz Angeborene Herzfehler

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09-10
• Last Update Posted: 28 August 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

specific:

•the patient/ his parents got a consent form and agreed to a informed consent for this cinical trial
•negative pregnancy test
•no participation in an other medical trial 4 weeks before and during this trial

specific
•Fallot tetralogy after repair
group A (n = 45): youth = 14 years or adult patients after repair of fallots tetralogy, with planed pulmonary valve replacement due relevant pulmonary insufficiency
Group B (n = 35): youth = 14 Jahre or adult patients after repair of fallots tetralogy with good results after repair with good right heart function

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- pregnancy or lactation
- childbearing women without sufficient contraception
- diseases which exclude the patient the patient from the participation after evaluation through the treating md
- abuse of alcohol, medecine or addictive drugs
- other medical, psychological or social conditions, which complicate -raise the risk for the treatment of the patient (trisomia 21, psychiatric diseases)
- lack of compliance or expected lack of ability to comply
- lack of willingness to save and transfer pseudonymized data in course of the trial
- Persons who are detained officially or legally to an official institute
-contra-indications against pharmacological treatment like ventricular tachykardia or similar, pulmonary valve stenosis or pulmonary hypertension
- present or high risk of coronary heart disease
- present or known atrial fibrilation or flutter
- double-outlet right ventrical
- associated servere heart failures
- associated servere valve failures, exept pulmonary valve insufficiancy
- other relevant tumor or active diseases
- absolut conta-indications for MRI, like pacemaker
- patient unable to participate in stress tests
- patients with contra-indications for the treatment with dobutamine
- patients with diabetes
- patients with concomitant containdicant treatment

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified