Status:
COMPLETED
Cardiac Repercussion of Systemic Sclerodermias
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Systemic Scleroderma
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Systemic sclerodermia is a connectivity characterized by multiple visceral impairments, in particular pulmonary, which can lead to the development of a Pulmonary Arterial Hypertension (PAHT). In one ...
Eligibility Criteria
Inclusion
- Age between 18 years and 75 years
- Having a maximum speed of IT \< 2.8 m/sec.
- Having read and understood the information note and having signed the informed consent form.
- And :
- Either carrying a systemic sclerodermia satisfying the criteria of American College of Rheumatology (the presence of a major criteria or two minor criterias is required for the systemic diagnosis of sclerodermia):
- Major criteria: proximal sclerodermia defined by a bilateral cutaneous sclerosis extending beyond the metacarpophalangeal and metatarsophalangeal joint.
- Minor criteria: pulpar sclerodactylia, pulpar canker or scars, pulmonary fibrosis on thoracic radiography.
- Or presenting CREST syndrome, with at least 4 of the 5 following criterias :
- subcutaneous calcinosis,
- syndrome of Raynaud,
- attack oesophagienne,
- sclerodactylia,
- telangiectasis.
Exclusion
- Over 75 years
- Having a maximum speed of TI \> 2.8 m/sec.
- Patient affected by a connectivitis other than a sclerodermia : mixed connectivity, disseminated erythematous lupus, inflammatory idiopathic myopathy, rheumatoïd polyarthritis.
- Patient carrying a sclerodermia complicated by:
- renal failure (clearance \> 30 ml - Cockraft)
- recent heart failure (\< 2 months)
- cardiac valvular attack, dilated, hypertrophic or restrictive cardiomyopathy, constrictive pericarditis, chronic pulmonary heart or antecedent of myocarditis
- Coronaropathy objectified by stenosis or simple coronary irregularities on the coronarography or antecedent of myocardial infarction
- Chronic respiratory handicap with another origin than sclerodermia
- Unsigned informed consent form
- Patient with mental or psychiatric disorders, unable or unwilling to comply with protocol requirements.
- Patient treated with intraveinous derived of prostacyclin within 1 month before inclusion
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT00697736
Start Date
March 1 2007
End Date
December 1 2014
Last Update
May 28 2019
Active Locations (1)
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1
Hôpital Louis Pradel
Bron, France, 69 677