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IMR-Heart Trasplant Study

NCT06656065 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2025-11-21

No results posted yet for this 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.

Conditions

  • Heart Transplant Rejection
  • Microvascular Resistance

Sponsors & Collaborators

  • Central University Hospital of Asturias

    collaborator UNKNOWN

  • University Hospital La Fe, Valencia

    collaborator UNKNOWN

  • University Hospital Virgen de la Arrixaca, Murcia

    collaborator UNKNOWN

  • University Hospital 12 Octubre, Madrid

    collaborator UNKNOWN

  • University Hospital Reina Sofia, Cordoba

    collaborator UNKNOWN

  • Bellvitge University Hospital

    collaborator UNKNOWN

  • University Hospital Virgen del Rocio, Sevilla

    collaborator UNKNOWN

  • Hospital Miguel Servet

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-23
Primary Completion
2028-05-23
Completion
2028-10-14

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06656065 on ClinicalTrials.gov