Status:
COMPLETED
Pulmonary Arteriopathy-Diagnostics and Therapy
Lead Sponsor:
Competence Network for Congenital Heart Defects
Collaborating Sponsors:
German Federal Ministry of Education and Research
Conditions:
Pulmonary Stenosis
Eligibility:
All Genders
6+ years
Brief Summary
Postoperative stenoses of the pulmonary artery vascular system seldom occur alone; they are frequently found in connection with congenital heart defects or malformation syndromes. The resulting increa...
Detailed Description
For patients with untreated peripheral pulmonary stenoses, the course of disease is characterised by a chronic pressure load of the right ventricle. In the medium to long term this can lead to right h...
Eligibility Criteria
Inclusion
- Patients with native or postoperative peripheral pulmonary stenoses (PPS; any stenoses that are located distally to the RVOT). Definition of PPS: 40% lumen constriction, or 30% constriction if volume stress is also present. Informed consent of the patient or his/her legal representative is given after instruction. -
Exclusion
- Patients unable to undergo MRI or spiroergometry for physical or psychological reasons.
- Pregnant or nursing patients. Patients affected by other clinically relevant diseases (malignant tumours, infectious diseases, metabolic disorders etc.). Patients with known intolerance of contrast media. Patients with syndromal diseases such as Alagille's syndrome, rubella embryopathy or elfin face syndrome. -
Key Trial Info
Start Date :
May 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT00266175
Start Date
May 1 2005
End Date
July 1 2008
Last Update
October 15 2008
Active Locations (5)
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1
Medizinische Hochschule Hannover
Hanover, Lower Saxony, Germany, D-30625
2
Herz-und Diabeteszentrum NRW
Bad Oeynhausen, North Rhine-Westphalia, Germany, D-32545
3
Deutsches Kinderherzzentrum
Sankt Augustin, North Rhine-Westphalia, Germany, D-53757
4
Universitätsklinikum des Saarlandes
Homburg, Saarland, Germany, D-66421