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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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28 August 2012 |
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Main ID: |
EUCTR2007-003461-41-DE |
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Date of registration:
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10/09/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Cardiac imaging under dobutamine stress for early assessment of right ventricular function in patients with tetralogy of Fallot and pulmonary regurgitation - Fallot-stress
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Scientific title:
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Cardiac imaging under dobutamine stress for early assessment of right ventricular function in patients with tetralogy of Fallot and pulmonary regurgitation - Fallot-stress |
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Date of first enrolment:
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13/11/2007 |
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Target sample size:
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80 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-003461-41 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised:
Open: yes
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other: yes
Other specify the comparator: standard rest cardiac MRI
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Phase:
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Countries of recruitment
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Germany
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Contacts
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Key inclusion & exclusion criteria
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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
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Fallot tetralogy late after repair with marked pulmonary valve incompetence
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Intervention(s)
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Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: Dobutamine
Concentration unit: µg/kg microgram(s)/kilogram
Concentration type: range
Concentration number: 10-20
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Primary Outcome(s)
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Primary end point(s): - analysis with ANOVA for follow-up measurements with determinants of regular and stress MRI to compare group A with group B, (resp.) comparision both visits group A
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Main Objective: The main objective of this trial is to define new cardial functional parameters of early right cardial insufficiency by pre- and postoperative characterisation of right heart function with a Dobutamine stress MRI compared to routine cardiac MRI
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Secondary Objective: Secondary objectives of this trial are:
- to define new cardial functional parameters of early right cardial insufficiency by pre- and postoperative characterisation of right heart function with a Dobutamine stress echocardiogram. Correlation to routine cardiac MRI and a Dobutamine stress MRI.
- to define new cardial functional parameters of early right cardial insufficiency by pre- and postoperative characterisation of right heart function with a tissue Doppler echocardiogram and three-dimensional echocardiography. Correlation to routine cardiac MRI and a Dobutamine stress MRI.
- to evaluate mortality, morbidity, pulmonary function, objective exercise tolerance, life-quality and prevalence of cardiac arrhythmia after pulmonary valve replacement
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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