Heart Failure After Heart Transplantation Due to Chronic Rejection

NCT ID: NCT03808324

Last Updated: 2019-01-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-31
• Study Completion Date: 2021-03-31

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.

Detailed 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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Heart transplant recipients

Group Type: EXPERIMENTAL

Diagnostic investigations

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Diagnostic investigations

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sahlgrenska University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sorosh Esmaily

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sahlgrenska University Hospital

Gothenburg, , Sweden

Site Status: RECRUITING

Countries

Sweden

Facility Contacts

Sorosh Esmaily, MD

Role: primary

sorosh.esmaily@gu.se

+46707488821

Other Identifiers

AVALON

Identifier Type: -

Identifier Source: org_study_id