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NCT03499197 Clinical Trial

Heart TIMING - Heart Transplantation IMagING

Magnetic Resonance Imaging Clinical Trial

Official title:
Morphological and Functional Changes After Heart Transplantation - Role of Noninvasive Imaging in the Early Detection of Cardiac Allograft Rejection and Vasculopathy

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03499197
Other study ID # Heart TIMING 001
Secondary ID
Status Recruiting
Phase
First received April 11, 2018
Last updated April 13, 2018
Start date January 15, 2018
Est. completion date January 15, 2026

Study information
Verified date April 2018
Source Semmelweis University Heart and Vascular Center
Contact Hajnalka Vago, MD, PhD
Phone +3620 8258058
Email vagoha@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

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)

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date January 15, 2026
Est. primary completion date January 15, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- First heart transplantation

Exclusion Criteria:

- Cardiogenic shock on/after day 28 after heart transplantation

- Lack of consent

- Lack of cooperation

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• cardiac magnetic resonance imaging
Detailed and regular CMR examination (LGE, stress perfusion, T1, T2 mapping)

Locations
Country Name City State
Hungary Heart and Vascular Center, Semmelweis University Budapest

Sponsors (2)
Lead Sponsor Collaborator
Semmelweis University Heart and Vascular Center National Research, Development and Innovation Fund of Hungary, Project no. NVKP_16-1-2016-0017

Country where clinical trial is conducted

Hungary, 

Outcome
Type Measure Description Time frame Safety issue
Primary Coronary allograft vasculopathy Coronary allograft vasculopathy confirmed based on IVUS/OCT 5 years
Primary Coronary allograft rejection Coronary allograft rejection confirmed based on endomyocardial biopsy/clinical parameters 5 years
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