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FOLLOW HEART TRANSPLANT FOR ACHIEVING THE HEART PRIMITIVE RELATED SCLERODERMA SYSTEMIC

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ClinicalTrials.gov Identifier: NCT02808481
Recruitment Status : Unknown
Verified May 2016 by University Hospital, Strasbourg, France.
Recruitment status was:  Not yet recruiting
First Posted : June 21, 2016
Last Update Posted : June 21, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Brief Summary:

Systemic sclerosis is a rare disease. The early cardiac disease affects 10% of patients sclérodemiques.

Heart transplantation in the early cardiac involvement in systemic sclerosis is exceptional.

we see patient data analysis with systemic sclerosis who used cardiac transplantation to understand the primitive cardiac damage associated with systemic sclerosis


Condition or disease
Systemic Sclerosis

Study Type : Observational
Estimated Enrollment : 9 participants
Observational Model: Cohort
Time Perspective: Retrospective
Study Start Date : June 2016
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016





Primary Outcome Measures :
  1. Analysis of data from patients with systemic sclerosis who used cardiac transplantation for primary cardiac involvement [ Time Frame: 1month post-transplantation ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients with systemic sclerosis who used cardiac transplantation for primary cardiac involvemen
Criteria

Inclusion criteria:

  • Adult patients meet the criteria for classification of systemic sclerosis
  • Adverse primitive heart that required a heart transplant
  • Patients who have given their verbal agreement to use their data for research purposes.

Exclusion criteria:

  • Localized Scleroderma or sclerodermiform syndrome
  • Heart disease secondary to pulmonary or renal impairment
  • Refusal to participate in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02808481


Contacts
Contact: Emmanuel CHATELUS, MD 33 (0)3.88.12.81.15 emmanuel.chatelus@chru-strasbourg.fr

Sponsors and Collaborators
University Hospital, Strasbourg, France

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT02808481     History of Changes
Other Study ID Numbers: 6410
First Posted: June 21, 2016    Key Record Dates
Last Update Posted: June 21, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University Hospital, Strasbourg, France:
systemic sclerosis
cardiac disease
Heart transplantation
primitive cardiac damage

Additional relevant MeSH terms:
Sclerosis
Scleroderma, Systemic
Scleroderma, Diffuse
Pathologic Processes
Connective Tissue Diseases
Skin Diseases