IMR-Heart Trasplant Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHospital Miguel Servet

About this trial

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 criteria

Qualifiers

Heart transplant patients >18 years.

Patients who have received and signed informed consent.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

100 Participants
are grouped into 2 trial groups

Sponsors and collaborators

Hospital Miguel Servet

Lead sponsor

Central University Hospital of Asturias

Collaborator

Hospital Universitario La Fe

Collaborator

University Hospital Virgen de la Arrixaca, Murcia

Collaborator

University Hospital 12 Octubre, Madrid

Collaborator

Hospital Universitario Reina Sofia de Cordoba

Collaborator

Bellvitge University Hospital

Collaborator

Hospitales Universitarios Virgen del Rocío

Collaborator