NCT02808481

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
9

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2016

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

June 17, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 21, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

June 21, 2016

Status Verified

May 1, 2016

Enrollment Period

6 months

First QC Date

June 17, 2016

Last Update Submit

June 20, 2016

Conditions

Systemic Sclerosis

Keywords

systemic sclerosiscardiac diseaseHeart transplantationprimitive cardiac damage

Outcome Measures

Primary Outcomes (1)

  • Analysis of data from patients with systemic sclerosis who used cardiac transplantation for primary cardiac involvement

    1month post-transplantation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Scleroderma, SystemicHeart Diseases

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin DiseasesCardiovascular Diseases

Central Study Contacts

Emmanuel CHATELUS, MD

CONTACT

33 (0)3.88.12.81.15emmanuel.chatelus@chru-strasbourg.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2016

First Posted

June 21, 2016

Study Start

June 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

June 21, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share