Index Microvascular Resistance (IMR) in Heart Transplant Patients

Status: Recruiting
Location: See all (2) locations...
Study Type: Observational
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
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: 100
Treatments
IMR≥15
Heart trasplant patient with an index of microvascular resistance ≥ 15 measured in the first three months in the physiological study.
IMR<15
Heart trasplant patient with an index of microvascular resistance\<15 measured in the first three 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