NCT03499197

Brief Summary

The cardiac allograft rejection (CAR) and cardiac allograft vasculopathy (CAV) significantly affect the prognosis of patients after heart transplantation. The aim of the present study is to investigate and differentiate the adaptive and pathological cardiovascular changes after heart transplantation using different modalities. The investigator's main purpose is to define the role of the cardiovascular imaging methods and biomarkers in the early diagnosis of CAR and CAV.

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 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

January 15, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 17, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2021

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2026

Completed
Last Updated

April 17, 2018

Status Verified

April 1, 2018

Enrollment Period

3 years

First QC Date

April 11, 2018

Last Update Submit

April 13, 2018

Conditions

Heart Transplant Failure and RejectionMagnetic Resonance Imaging

Outcome Measures

Primary Outcomes (2)

  • Coronary allograft vasculopathy

    Coronary allograft vasculopathy confirmed based on IVUS/OCT

    5 years

  • Coronary allograft rejection

    Coronary allograft rejection confirmed based on endomyocardial biopsy/clinical parameters

    5 years

Interventions

cardiac magnetic resonance imagingDIAGNOSTIC_TEST

Detailed and regular CMR examination (LGE, stress perfusion, T1, T2 mapping)

Eligibility Criteria

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

Patients who underwent first cardiac transplantation.

You may qualify if:

  • First heart transplantation

You may not qualify if:

  • Cardiogenic shock on/after day 28 after heart transplantation
  • Lack of consent
  • Lack of cooperation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heart and Vascular Center, Semmelweis University

Budapest, Hungary

RECRUITING

MeSH Terms

Conditions

Rejection, Psychology

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Central Study Contacts

Hajnalka Vago, MD, PhD

CONTACT

+3620 8258058vagoha@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD, Associate Professor

Study Record Dates

First Submitted

April 11, 2018

First Posted

April 17, 2018

Study Start

January 15, 2018

Primary Completion

January 15, 2021

Study Completion

January 15, 2026

Last Updated

April 17, 2018

Record last verified: 2018-04

Locations

HU(1)