Heart TIMING - Heart Transplantation IMagING

NCT ID: NCT03499197

Last Updated: 2018-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-15

Study Completion Date

2026-01-15

Brief Summary

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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.

Detailed Description

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1. 12-lead ECG - Resting standard 12-lead digital ECG will be recorded. Extended analysis will be performed according to the latest recommendations.
2. Holter ECG - 24 hour Holter ECG will be recorded. Extended Holter ECG analysis will be performed.
3. Life quality questionnaire, patient history - Detailed questionnaire about personal and family history, general symptoms and life quality.
4. Laboratory biochemical examination - Besides the regular routine laboratory parameters, several specific parameters are planned to be measured, such as cardiac biomarkers.
5. Endomyocardial biopsy
6. Detailed transthoracic echocardiography including strain analysis and 3D measurement
7. Detailed cardiac magnetic resonance (CMR) examination
8. Coronary imaging - invasive coronarography and intravascular ultrasound (IVUS) and/or optical coherence tomography (OCT)
9. Invasive pressure measurement - Measurement of coronary flow reserve (CFR) and microcirculation resistance index (IMR)

Conditions

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Heart Transplant Failure and Rejection Magnetic Resonance Imaging

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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cardiac magnetic resonance imaging

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* First heart transplantation

Exclusion Criteria

* Cardiogenic shock on/after day 28 after heart transplantation
* Lack of consent
* Lack of cooperation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Research, Development and Innovation Fund of Hungary, Project no. NVKP_16-1-2016-0017

UNKNOWN

Sponsor Role collaborator

Semmelweis University Heart and Vascular Center

OTHER

Sponsor Role lead

Responsible Party

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Hajnalka Vágó MD PhD

MD PhD, Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Heart and Vascular Center, Semmelweis University

Budapest, , Hungary

Site Status RECRUITING

Countries

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Hungary

Central Contacts

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Hajnalka Vago, MD, PhD

Role: CONTACT

+3620 8258058

Facility Contacts

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Hajnalka Vago, MD, PhD

Role: primary

Other Identifiers

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Heart TIMING 001

Identifier Type: -

Identifier Source: org_study_id

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