NCT03050892

Brief Summary

Evaluate the association between donor soluble protein ST2 (sST2) serum levels and 30-day recipient mortality in order to improve graft screening.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

February 29, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 13, 2017

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

February 13, 2017

Status Verified

February 1, 2017

Enrollment Period

1 year

First QC Date

February 5, 2017

Last Update Submit

February 8, 2017

Conditions

Heart Transplant Failure and Rejection

Outcome Measures

Primary Outcomes (1)

  • Survival

    Compare mean donor sST2 serum levels in recipients who died at 30 days versus mean donor sST2 serum levels in recipients who survived at 30 days.

    30 days

Secondary Outcomes (2)

  • Survival and Rejection and IL-33

    1 year

  • Survival and Rejection and sST2

    1 year

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Heart donors and heart recipients

You may qualify if:

  • Consenting recipients
  • Consenting donors to organ/tissue donation for the purpose of scientific research

You may not qualify if:

  • Non consenting recipients
  • Non consenting donors to organ/tissue donation for the purpose of scientific research
  • Multi-organ transplantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Thoracic and Cardiovascular Surgery, Cardiac Institute, Groupe Hospitalier La Pitié Salpêtrière

Paris, 75013, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Rejection, Psychology

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Central Study Contacts

Antonella Galeone, MD, PhD

CONTACT

0033664841652a.galeone@email.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

February 5, 2017

First Posted

February 13, 2017

Study Start

February 29, 2016

Primary Completion

March 1, 2017

Study Completion

May 1, 2018

Last Updated

February 13, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)