Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Heart TIMING - Heart Transplantation IMagING

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03499197
Recruitment Status : Recruiting
First Posted : April 17, 2018
Last Update Posted : April 17, 2018
Sponsor:
Collaborator:
National Research, Development and Innovation Fund of Hungary, Project no. NVKP_16-1-2016-0017
Information provided by (Responsible Party):
Hajnalka Vágó MD PhD, 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.

Condition or disease Intervention/treatment
Heart Transplant Failure and Rejection Magnetic Resonance Imaging Diagnostic Test: cardiac magnetic resonance imaging

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)

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Morphological and Functional Changes After Heart Transplantation - Role of Noninvasive Imaging in the Early Detection of Cardiac Allograft Rejection and Vasculopathy
Actual Study Start Date : January 15, 2018
Estimated Primary Completion Date : January 15, 2021
Estimated Study Completion Date : January 15, 2026

Resource links provided by the National Library of Medicine



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


Primary Outcome Measures :
  1. Coronary allograft vasculopathy [ Time Frame: 5 years ]
    Coronary allograft vasculopathy confirmed based on IVUS/OCT

  2. Coronary allograft rejection [ Time Frame: 5 years ]
    Coronary allograft rejection confirmed based on endomyocardial biopsy/clinical parameters



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who underwent first cardiac transplantation.
Criteria

Inclusion Criteria:

  • First heart transplantation

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03499197


Contacts
Layout table for location contacts
Contact: Hajnalka Vago, MD, PhD +3620 8258058 vagoha@gmail.com

Locations
Layout table for location information
Hungary
Heart and Vascular Center, Semmelweis University Recruiting
Budapest, Hungary
Contact: Hajnalka Vago, MD, PhD         
Sponsors and Collaborators
Semmelweis University Heart and Vascular Center
National Research, Development and Innovation Fund of Hungary, Project no. NVKP_16-1-2016-0017

Additional Information:

Layout table for additonal information
Responsible Party: Hajnalka Vágó MD PhD, MD PhD, Associate Professor, Semmelweis University Heart and Vascular Center
ClinicalTrials.gov Identifier: NCT03499197    
Other Study ID Numbers: Heart TIMING 001
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No