Evaluating microvascular resistance in heart transplant patients
Official title: Index Microvascular Resistance (IMR) in Heart Transplant Patients
Run by Hospital Miguel Servet · NCT06656065 · Data updated 2026-11-12
This study tests if measuring blood flow in the small vessels of heart transplant patients can help reduce the need for repeated heart tissue tests.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Hospital Miguel Servet Academic / other |
| Locations | 2 sites (L'Hospitalet de Llobregat, Barcelona and 1 other locations) |
| Status | Recruiting |
| Started | May 23, 2023 |
| Main results expected | May 23, 2028 |
| Study ends | October 14, 2028 |
| Registry record updated | November 21, 2025 |
| Trial ID | NCT06656065 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are heart transplant patients over 18 years old who are stable and can provide informed consent.
✕Probably not a fit
Patients with hemodynamic instability, acute cellular rejection, or certain contraindications will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to assess the index of microvascular resistance (IMR) in heart transplant patients to determine its effectiveness in reducing the need for endomyocardial biopsies (EMB). By measuring IMR, coronary flow reserve (CFR), and fractional flow reserve (FFR) within the first two months and one year post-transplant, the study seeks to improve patient care and minimize complications associated with repeated EMBs. The study will involve multiple centers and will include stable heart transplant patients who provide informed consent.
Why it matters
Potential benefit: If successful, this approach could lead to fewer invasive procedures and better management of heart transplant patients.
How similar studies have gone: While non-invasive techniques have been explored, this specific approach using IMR has not been previously evaluated in this context.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Hospital Miguel Servet
Zaragoza, Zaragoza, Spain Recruiting -
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain Active not recruiting
Study contacts
- Study coordinator: Georgina Fuertes, MD PHD
- Email: georginaff@hotmail.com
- Phone: 0034 976765500
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Nationwide Swedish program testing donor-derived cell-free DNA to monitor rejection after heart transplant
This project tests whether a blood test measuring donor-derived cell-free DNA can help monitor rejection in adults who have had a heart transplant.
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Using mobile video to help young heart transplant patients take their medications
This study tests whether using mobile videos can help young heart transplant patients remember to take their medications regularly.
-
Evaluating donor-derived DNA levels in heart transplant rejection
This study is testing whether measuring donor DNA in the blood can help doctors better understand and detect heart transplant rejection in patients who are already having biopsies.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.