Heart Failure After Heart Transplantation Due to Chronic Rejection

NCT03808324 | Unknown DMC

• 1 other identifier: AVALON
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study will investigate the prevalence of allograft vasculopathy and unexplained graft dysfunction during long-term follow-up after heart transplantation. Risk factors as well diagnostic approaches will be investigated.

Conditions

Cardiac Allograft Vasculopathy; Chronic Rejection of Cardiac Transplant; Graft Dysfunction

Outcome Measures

Primary Outcomes (4)

• Degree of stenosis in coronary arteries

  Coronary angiography gives information about the degree of stenosis in the coronary arteries. In connection with the angiography Optical Coherence Tomography (OCT) will be performed. A precise measurement and characterization of the intima can be performed by OCT.

  4 hours

• Restrictive allograft hemodynamics

  Right heart catheterization will be performed using a Swan-Ganz pulmonary artery thermodilution catheter. Right atrial pressure (RAP), mean pulmonary artery pressure (MPAP), pulmonary capillary wedge pressure (PCWP) and mean arterial pressure (MAP). Cardiac output (CO) and cardiac index (CI) will be recorded by thermodilution. The transpulmonary gradient (TPG) is obtained by subtracting PCWP from MPAP and PVR (in Wood units (WU) by dividing TPG by CO. Measurement will be performed both at rest and after supine bicycle exercise. A restrictive allograft filling pattern will be defined as PCW at rest exceeding 15 mmHg and/or exceeding 25 mmHg during exercise.

  2 hours

• Functional assessment of the microvasculature

  Coronary flow reserve (CRF) measurements may provide functional assessment of the microvasculature. Coronary blood flow velocity (CBFV) is measured in the left anterior descending coronary artery (LAD) before, and during constant adenosine infusion using conventional color Doppler ultrasound equipped with coronary imaging protocol. Mid-distal LAD segment is visualized using high frequency color Doppler (\>3 MHz) in the anterior interventricular sulcus. A CINE-loop is then stored to document the 2-D image of LAD. Thereafter spectral Doppler is used to record CBFV. Mean diastolic flow velocity is calculated by manually tracing the diastolic flow velocity signal. Baseline CBFV values are calculated using the mean value of three representative heart beats during resting condition. The mean hyperemic CBFV is calculated as the mean of the three highest CBFV values recorded during the whole infusion period. The ratio between hyperemic and baseline CBFV is defined as CFR.

  2 hours

• Degree of myocardial fibrosis

  Measurement of myocardial T1 times (T1 mapping) with gadolinium-enhanced inversion recovery-prepared sequences may depict diffuse myocardial fibrosis and has good correlation with ex vivo fibrosis content. T1 mapping calculates myocardial T1 relaxation times with image-based signal intensities and will be performed with standard cardiac MR imagers and radiologic workstations.

  4 hours

Study Arms (1)

Heart transplant recipients

EXPERIMENTAL

Diagnostic Test: Diagnostic investigations

Interventions

Diagnostic investigations DIAGNOSTIC_TEST

Participants will undergo tests and diagnostics investigations to identify signs of chronic rejection after heart transplantation.

Heart transplant recipients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Heart transplant performed more than 10 years and less than 21 years ago
• Scheduled yearly post-transplant control
• Signed informed consent

You may not qualify if:

• Estimated GFR \< 30 mL/min/1,73m2
• Radiographic contrast allergy
• Severe asthma or COLD with FEV1 \< 50%
• Second or third degree AV block
• Pregnancy
• In the Investigator's opinion, the patient has a clinically significant disease that could be adversely affected by study participation

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, 413 45, Sweden

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 29, 2018
• First Posted: January 17, 2019
• Study Start: January 1, 2019
• Primary Completion: January 1, 2021
• Study Completion: March 1, 2021
• Last Updated: January 17, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)