FOLLOW HEART TRANSPLANT FOR ACHIEVING THE HEART PRIMITIVE RELATED SCLERODERMA SYSTEMIC

June 20, 2016 updated by: University Hospital, Strasbourg, France

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

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

9

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients with systemic sclerosis who used cardiac transplantation for primary cardiac involvemen

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Analysis of data from patients with systemic sclerosis who used cardiac transplantation for primary cardiac involvement
Time Frame: 1month post-transplantation
1month post-transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

June 17, 2016

First Submitted That Met QC Criteria

June 20, 2016

First Posted (Estimate)

June 21, 2016

Study Record Updates

Last Update Posted (Estimate)

June 21, 2016

Last Update Submitted That Met QC Criteria

June 20, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6410

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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