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Clinical Trials in Spain / NCT06656065
Recruiting Observational

IMR-Heart Trasplant Study

NCT06656065 · tracked via the Priya Life Science Spain tracker
Phase
Observational
Started
2023-05-23
Last updated
2025-11-21

Condition(s) studied

Heart Transplant RejectionMicrovascular Resistance

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Heart transplant patients \>18 years. * Patients who have received and signed informed consent. Exclusion Criteria: * Patients with hemodynamic instability after HT, including cardiogenic shock or severe coagulopathy. * Patients with acute cellular rejection before intracoronary physiological assessment. * Patients with bronchial asthma or bronchopathy with a positive bronchodilation test, which contraindicates the use of adenosine. * Patients with epicardial coronary lesions with a resting physiological index ≤0.89 or ≤0.80 at hyperemia. * Patients unlikely to cooperate or with inability or unwillingness to give informed consent.

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Hospital Universitario de Bellvitge L'Hospitalet de Llobregat Barcelona Active Not Recruiting
Hospital Miguel Servet Zaragoza Zaragoza Recruiting

More Hospital Miguel Servet trials in Spain

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06656065 on ClinicalTrials.gov ↗ ← All trials in Spain