Actively Recruiting

Age: 18Years +
All Genders
NCT06656065

IMR-Heart Trasplant Study

Led by Hospital Miguel Servet · Updated on 2025-11-21

100

Participants Needed

2

Research Sites

281 weeks

Total Duration

On this page

Sponsors

H

Hospital Miguel Servet

Lead Sponsor

C

Central University Hospital of Asturias

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

IMR-Heart Trasplant Study

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Heart transplant patients over 18 years old
  • Patients who have received and signed informed consent
Not Eligible

You will not qualify if you...

  • Patients with hemodynamic instability after heart transplant, including cardiogenic shock or severe coagulopathy
  • Patients with acute cellular rejection before coronary physiological assessment
  • Patients with bronchial asthma or bronchopathy with a positive bronchodilation test that prevents use of adenosine
  • Patients with epicardial coronary artery lesions causing low resting or hyperemic blood flow index
  • Patients unlikely to cooperate or unable or unwilling to give informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain, 08907

Active, Not Recruiting

2

Hospital Miguel Servet

Zaragoza, Zaragoza, Spain, 50009

Actively Recruiting

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Research Team

G

Georgina Fuertes, MD PHD

CONTACT

A

Ainhoa Perez Guerrero, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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