Index Microvascular Resistance (IMR)-guided Management of Heart Transplantation (IMR-Heart Transplant Study)

Status: Recruiting
Location: See all (2) locations...
Study Type: Observational
SUMMARY

Endomyocardial biopsy (EMB) is the gold standard method to guide post-heart trasplant (HT) patients, as it represents the best tool to identify rejection in orthotopic HT. However, it is frequently repeated during the first year, with some variations depending on each center protocol and it is potentially associated with serious complications.Several studies have presented the association between acute allograft rejection, micro-vasculopathy and cardiac allograft epicardial vasculopathy (CAV). Index of microvascular resistance (IMR) measured early after HT has been significantly associated with the risk of acute cellular rejection (ACR). The aim of this study will be to evaluate if the use of IMR early after HT may improve the patients care after HT, by reducing the number of EMB.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Heart transplant patients \>18 years.

• Patients who have received and signed informed consent.

Locations
Other Locations
Spain
Hospital Universitario de Bellvitge
ACTIVE_NOT_RECRUITING
L'hospitalet De Llobregat
Hospital Miguel Servet
RECRUITING
Zaragoza
Contact Information
Primary
Georgina Fuertes, MD PHD
georginaff@hotmail.com
0034 976765500
Backup
Ainhoa Perez Guerrero, MD
ainhoaperezguerrero@gmail.com
Time Frame
Start Date: 2023-05-23
Estimated Completion Date: 2028-10-14
Participants
Target number of participants: 48
Treatments
IMR≥15
Heart trasplant patient with an index of microvascular resistance ≥ 15 measured in the first two months in the physiological study.
IMR<15
Heart trasplant patient with an index of microvascular resistance\<15 measured in the first two months in the physiological study.
Related Therapeutic Areas
Sponsors
Collaborators: University Hospital Reina Sofia, Cordoba, Bellvitge University Hospital, University Hospital 12 Octubre, Madrid, University Hospital Virgen del Rocio, Sevilla, University Hospital La Fe, Valencia, Central University Hospital of Asturias, University Hospital Virgen de la Arrixaca, Murcia
Leads: Hospital Miguel Servet

This content was sourced from clinicaltrials.gov