| NCT ID | NCT06656065 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital Miguel Servet |
| Condition | Heart Transplant Rejection |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-05-23 |
| Primary Completion | 2028-05-23 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2023-05-23 with a primary completion date of 2028-05-23.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Heart transplant patients \>18 years. * Patients who have received and signed informed consent. Exclusion Criteria: * 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. * Patients unlikely to cooperate or with inability or unwillingness to give informed consent.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06656065 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Transplant Rejection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06656065 currently recruiting?
Yes, NCT06656065 is actively recruiting participants. Contact the research team at georginaff@hotmail.com for enrollment information.
Where is the NCT06656065 trial being conducted?
This trial is being conducted at L'Hospitalet de Llobregat, Spain, Zaragoza, Spain.
Who is sponsoring the NCT06656065 clinical trial?
NCT06656065 is sponsored by Hospital Miguel Servet. The trial plans to enroll 100 participants.