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

This trial does not accept healthy volunteers

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 population

Heart trasplant patients that have signed informed consent and meet all inclusion and exclusion criteria for undergoing IMR assessment.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

100 Participants
are grouped into 2 trial groups
Group A: IMR≥15
Group B: IMR<15

Trial outcomes

Primary outcomes

1

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.

Time frame
One year

Secondary outcomes

1

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.

Time frame
One year
2

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.

Time frame
One year
3

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.

Time frame
Five years
4

Cardiovascular mortality

Caused by cardiovascular disease or unknown death

Time frame
Five years

Other outcomes

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