Heart Failure After Heart Transplantation Due to Chronic Rejection (AVALON)

Sahlgrenska University Hospital

Status: Unknown

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

Treatments: Diagnostic Test: Diagnostic investigations

Study type: Interventional

Funder types: Other

Identifiers

NCT03808324

AVALON

Details and patient eligibility

About

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.

Full description

During long-term follow-up heart transplant recipients are at risk of developing different complications that are likely to affect quality of life and survival. The most common cause of death during the later stages after heart transplantation is cardiac allograft vasculopathy, followed by unexplained graft dysfunction. In this study, advanced imaging techniques will be used to describe the frequency of these two complications, examine possible risk factors and study consequences on functional capacity and quality of life. Further, the investigators will investigate whether it is feasible to screen for these conditions with non-invasive imaging methods. By studying patients that have performed cardiac transplantation between 10 and 20 years ago, the investigators expect to have a significant proportion of patients with these pathological conditions. Methods that will be used include cardiac magnetic resonance imaging, coronary flow velocity reserve assessment, right heart catheterization and coronary imaging with angiography and optical coherence tomography.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Heart transplant recipients

Experimental group

Treatment:

Diagnostic Test: Diagnostic investigations