Early Post Transplant Cardiac Allograft Vasculopathy

Active, not recruiting

• Conditions: Cardiac Allograft Vasculopathy

• Registration Number: NCT03217786
• Lead Sponsor: Ottawa Heart Institute Research Corporation

Brief Summary

Heart transplantation is an effective life-saving treatment for patients with end-stage heart disease. After a transplant, the new heart may develop narrowing in the arteries, causing heart failure, heart attacks and abnormal heart rhythms. This condition is known as cardiac allograft vasculopathy (CAV). The disease is very common, affecting almost a third of heart transplant patients by 5 years after transplant. CAV is a serious problem that causes the new heart to fail and is one of the main causes of death after transplant. Early detection of CAV is important as treatment options are poor once the disease is established. Currently, available techniques to evaluate CAV are limited by poor ability to detect disease early. The current tests usually focus on the large heart arteries and do not examine the smaller arteries that are also affected.

Detailed Description

The objective of this study is to determine whether early abnormalities of the heart arteries after heart transplantation can predict the development of CAV. We will use a combination of sophisticated imaging tools to examine in detail the early changes that occur in the arteries of a new heart. Heart transplant patients from the University of Ottawa Heart Institute and Toronto General Hospital will undergo a series of tests at 3 and 12 months after transplant. Statistical analyses will determine whether results from the above tests at 3 months predict the development of early CAV at 12 months after a heart transplant.

Study Timeline

• Study First Submitted: 2017-07-11
• Study First Submitted QC: 2017-07-11
• Study First Posted: 2017-07-14
• Study Start: 2018-02-12
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-08
• Primary Completion: 2026-03
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Heart transplant <3 months.
2. Age ≥18 years.
3. Able and willing to provide informed consent.

Exclusion Criteria

1. Contraindications to dipyridamole.
2. Contraindications to aminophylline.
3. Contraindications to nitroglycerin.
4. Contraindications to iodinated contrast.
5. Acute allograft rejection ≤1 month.
6. Uncontrolled heart failure or myocardial infarction ≤7 days.
7. Estimated glomerular filtration rate ≤30 mL/min.
8. Combined solid organ transplantation.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CAV on invasive coronary studies	3 months and 1-year post-transplant.	Changes in coronary intima on IVUS and OCT and invasive coronary flow

Secondary Outcome Measures

Name	Time	Method
PET	3 months post-transplant	Myocardial blood flow quantification
EMBx	3 months post-transplant	Microvascular disease
Biomarkers	3 months post-transplant	Serum biomarker panel

Trial Locations

Locations (1)

University of Ottawa Heart Institute; 🇨🇦 Ottawa, Ontario, Canada