NCT02400840

Brief Summary

Acute heart allograft rejection is a common complication after orthotopic heart transplantation. Primary objective of this study is to assess cardiac MRI as a tool for acute heart graft rejection screening, by detecting changes in myocardium structure especially extracellular volume.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

January 1, 2015

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 27, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

May 26, 2016

Status Verified

May 1, 2016

Enrollment Period

3 years

First QC Date

January 26, 2015

Last Update Submit

May 25, 2016

Conditions

Cardiac Graft

Outcome Measures

Primary Outcomes (1)

  • Number of patient with an acute rejection detected using Cardiac MRI after orthotopic heart transplantation

    Day 1

Secondary Outcomes (3)

  • Extracellular volume as measured by Cardiac MRI

    Day 1

  • T1 as measured by Cardiac MRI

    Day 1

  • T2 as measured by Cardiac MRI

    Day 1

Study Arms (2)

Heart graft rejection

EXPERIMENTAL

Assessment of cardiac allograft recipient with rejection by Cardiac MRI with gadobenic acid intravenous injection 0.2 ml/kg one time

Procedure: cardiac MRIDrug: gadobenic acid intravenous injection 0.2 ml/kg

No rejection

ACTIVE COMPARATOR

Assessment of cardiac allograft recipient without any rejection by Cardiac MRI with gadobenic acid intravenous injection 0.2 ml/kg one time

Procedure: cardiac MRIDrug: gadobenic acid intravenous injection 0.2 ml/kg

Interventions

cardiac MRIPROCEDURE

Cardiac MRI is done using gadobenic acid intravenous injection 0.2 ml/kg one time

Heart graft rejectionNo rejection
gadobenic acid intravenous injection 0.2 ml/kgDRUG

gadobenic acid intravenous injection 0.2 ml/kg is used one time for cardiac MRI assessment

Heart graft rejectionNo rejection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Orthotopic heart transplantation patients
  • Endomyocardial biopsies \< 72h
  • Estimated glomerular filtration ratio \>30ml/min (calculated by Cockcroft formula for patients age \< 65 yo or MDRD for patients age \>65 ans)
  • Patients affiliated to French national health insurance
  • For pre-menopausal female patients, negative pregnancy test
  • Patient's consent form signature
  • Patient with correct French writing and speaking comprehension

You may not qualify if:

  • Endomyocardial biopsies showing acute cellular rejection grade 1R or antibodies mediated rejection pAMR1
  • Patient in need of renal dialysis
  • Past history of allergic reaction or side effects after gadolinium infusion
  • Hemodynamical instability
  • MRI contra-indication (claustrophobia, ocular metallic objects, non MRI compatible cardiac device, neurological non RMI compatible device, osteosynthesis prosthesis older than 1980)
  • Pregnant or breast feeding woman
  • Patient participating to another clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rouen University Hospital

Rouen, 76031, France

Location

Study Officials

  • Arnaud GAY, MD

    University Hospital, Rouen

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2015

First Posted

March 27, 2015

Study Start

January 1, 2015

Primary Completion

January 1, 2018

Study Completion

May 1, 2018

Last Updated

May 26, 2016

Record last verified: 2016-05

Locations

FR(1)