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RECRUITING
NCT06656065

IMR-Heart Trasplant Study

Sponsor: Hospital Miguel Servet

View on ClinicalTrials.gov

Summary

Acute allograft rejection (AAR) is an important cause of morbi-mortality in heart transplant (HT) patients, particularly during the first year. Endomyocardial biopsy (EMB) is the "gold standard" to guide post- heart transplantation treatment. However, it is associated with complications that can be potentially serious. The index of microvascular resistance (IMR) is a specific physiological parameter used to assess microvascular function. Invasive coronary assessment has been shown to be both feasible and safe. Detection of coronary microvascular dysfunction (MCD) by IMR may help to identify high risk HT patients. In fact, an increased IMR measured early after HT has been associated with AAR, higher all-cause mortality and adverse cardiac events. A high IMR value early after HT may identify patients at higher risk who require increased surveillance or adjustments in immunosuppressive therapy. Conversely, a low IMR value may support reducing the number of EMBs. Our aim is to evaluate IMR in heart transplant patients within the first year. Changes in management after knowing IMR values and prognostic implications of IMR in a long term follow up will also be assessed.

Official title: Index Microvascular Resistance (IMR) in Heart Transplant Patients

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2023-05-23

Completion Date

2028-10-14

Last Updated

2025-11-21

Healthy Volunteers

No

Locations (2)

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Hospital Miguel Servet

Zaragoza, Zaragoza, Spain