NCT02347371

Brief Summary

The purpose of this registry is to determine the long term outcomes of heart transplantations performed at the Semmelweis University Heart and Vascular Center. All eventual interventional and non-interventional procedures will be accounted for and summarized.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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
14 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 27, 2015

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

April 23, 2021

Status Verified

April 1, 2021

Enrollment Period

5.3 years

First QC Date

January 15, 2015

Last Update Submit

April 22, 2021

Conditions

Disorder Related to Cardiac Transplantation

Keywords

Heart transplantCardiac allograft vasculopathyChronic rejectionImmunosuppressant therapy

Outcome Measures

Primary Outcomes (1)

  • Outcome of heart transplantation as measured by all-cause mortality

    All-cause mortality will be assessed after transplantation in all participating subjects.

    5 years

Secondary Outcomes (1)

  • Morbidity after heart transplantation

    5 years

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Heart transplant recipient, cared for by the Semmelweis University Heart and Vascular Center

You may qualify if:

  • Heart transplant recipient
  • \>18 years old
  • Signed informed consent
  • Cared for at the Semmelweis University Heart and Vascular Center

You may not qualify if:

  • Denies consent to registry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Semmelweis University Heart and Vascular Center

Budapest, 1122, Hungary

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

Study Officials

  • Béla Merkely, MD PhD DSc

    Semmelweis University Heart and Vascular Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2015

First Posted

January 27, 2015

Study Start

January 1, 2015

Primary Completion

May 1, 2020

Study Completion

May 1, 2020

Last Updated

April 23, 2021

Record last verified: 2021-04

Locations

HU(1)