Heart TIMING - Heart Transplantation IMagING

Recruiting

• Conditions: Heart Transplant Failure and Rejection; Magnetic Resonance Imaging

• Registration Number: NCT03499197
• Lead Sponsor: Semmelweis University Heart and Vascular Center

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.

Detailed Description

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)

Study Timeline

• Study Start: 2018-01-15
• Status Verified: 2018-04
• Study First Submitted: 2018-04-11
• Study First Submitted QC: 2018-04-13
• Last Update Submitted: 2018-04-13
• Study First Posted: 2018-04-17
• Last Update Posted: 2018-04-17
• Primary Completion: 2021-01-15
• Study Completion: 2026-01-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• First heart transplantation

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Coronary allograft vasculopathy	5 years	Coronary allograft vasculopathy confirmed based on IVUS/OCT
Coronary allograft rejection	5 years	Coronary allograft rejection confirmed based on endomyocardial biopsy/clinical parameters

Trial Locations

Locations (1)

Heart and Vascular Center, Semmelweis University; 🇭🇺 Budapest, Hungary