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
This trial does not accept healthy volunteersQualifiers
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 population
Heart trasplant patients that have signed informed consent and meet all inclusion and exclusion criteria for undergoing IMR assessment.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
IMR values in the first three months and one year after heart transplant
IMR measured by the invasive thermodilution technique. IMR is defined as the distal coronary pressure divided by the inverse of the hyperemic mean transit time and is expressed in units of mmHg.s.
Secondary outcomes
IMR variation between first three months after HT and one year
Comparison between the values of index of microvascular resistance (IMR) measured by bolus thermodilution technique between the first and 3rd month after HT and one year in the invasive physiological study. IMR may be expressed as mmHg·s.
Acute cellular rejection
A ≥2R degree according to the 2010 ISHLT system. Two or more focal infiltration points associated with myocyte injury in EMB. Diffuse infiltration with multi-focal myocyte injury with/without oedema, hemorrhage or vasculitis.
Cardiac allograft vasculopathy
Accelerated fibroproliferative process characterized by diffuse, concentric and longitudinal thickening of the intima of the vascular tree of the graft, affecting everything from the major epicardial arteries to the coronary microvasculature.
Cardiovascular mortality
Caused by cardiovascular disease or unknown death
Sponsors and contacts
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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