IMR-Heart Trasplant Study

NCT06656065 | Recruiting

• 1 other identifier: C.I. PI23/242
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Heart Transplant Rejection; Microvascular Resistance

Keywords

Heart Trasplant; Acute cellular rejection; IMR; Endomyocardial biopsy

Outcome Measures

Primary Outcomes (1)

• IMR values in the first three months and one year after heart transplant

  IMR measured by the invasive thermodilution technique. IMR is defined as the distal coronary pressure divided by the inverse of the hyperemic mean transit time and is expressed in units of mmHg.s.

  One year

Secondary Outcomes (7)

• IMR variation between first three months after HT and one year

  One year

• Acute cellular rejection

  One year

• Cardiac allograft vasculopathy

  Five years

• Cardiovascular mortality

  Five years

• Heart failure

  Five years

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Heart trasplant patients that have signed informed consent and meet all inclusion and exclusion criteria for undergoing IMR assessment.

You may qualify if:

• Heart transplant patients \>18 years.
• Patients who have received and signed informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Miguel Servet: lead
• Central University Hospital of Asturias: collaborator
• University Hospital La Fe, Valencia: collaborator
• University Hospital Virgen de la Arrixaca, Murcia: collaborator
• University Hospital 12 Octubre, Madrid: collaborator
• University Hospital Reina Sofia, Cordoba: collaborator
• Bellvitge University Hospital: collaborator
• University Hospital Virgen del Rocio, Sevilla: collaborator

Study Sites (2)

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

ACTIVE NOT RECRUITING

Hospital Miguel Servet

Zaragoza, Zaragoza, 50009, Spain

RECRUITING

Related Publications (8)

• Lee JM, Choi KH, Choi JO, Shin D, Park Y, Kim J, Lee SH, Kim D, Yang JH, Cho YH, Sung K, Choi JY, Park M, Kim JS, Park TK, Song YB, Hahn JY, Choi SH, Gwon HC, Oh JK, Jeon ES. Coronary Microcirculatory Dysfunction and Acute Cellular Rejection After Heart Transplantation. Circulation. 2021 Nov 2;144(18):1459-1472. doi: 10.1161/CIRCULATIONAHA.121.056158. Epub 2021 Sep 3.

  PMID: 34474597 BACKGROUND

• Okada K, Honda Y, Luikart H, Yock PG, Fitzgerald PJ, Yeung AC, Valantine HA, Khush KK, Fearon WF. Early invasive assessment of the coronary microcirculation predicts subsequent acute rejection after heart transplantation. Int J Cardiol. 2019 Sep 1;290:27-32. doi: 10.1016/j.ijcard.2019.04.018. Epub 2019 Apr 8.

  PMID: 30987835 BACKGROUND

• Ahn JM, Zimmermann FM, Gullestad L, Angeras O, Karason K, Russell K, Lunde K, Okada K, Luikart H, Khush KK, Honda Y, Pijls NHJ, Lee SE, Kim JJ, Park SJ, Solberg OG, Fearon WF. Microcirculatory Resistance Predicts Allograft Rejection and Cardiac Events After Heart Transplantation. J Am Coll Cardiol. 2021 Dec 14;78(24):2425-2435. doi: 10.1016/j.jacc.2021.10.009.

  PMID: 34886963 BACKGROUND

• Hiemann NE, Wellnhofer E, Knosalla C, Lehmkuhl HB, Stein J, Hetzer R, Meyer R. Prognostic impact of microvasculopathy on survival after heart transplantation: evidence from 9713 endomyocardial biopsies. Circulation. 2007 Sep 11;116(11):1274-82. doi: 10.1161/CIRCULATIONAHA.106.647149. Epub 2007 Aug 20.

  PMID: 17709643 BACKGROUND

• Saraiva F, Matos V, Goncalves L, Antunes M, Providencia LA. Complications of endomyocardial biopsy in heart transplant patients: a retrospective study of 2117 consecutive procedures. Transplant Proc. 2011 Jun;43(5):1908-12. doi: 10.1016/j.transproceed.2011.03.010.

  PMID: 21693299 BACKGROUND

• Khush KK, Cherikh WS, Chambers DC, Harhay MO, Hayes D Jr, Hsich E, Meiser B, Potena L, Robinson A, Rossano JW, Sadavarte A, Singh TP, Zuckermann A, Stehlik J; International Society for Heart and Lung Transplantation. The International Thoracic Organ Transplant Registry of the International Society for Heart and Lung Transplantation: Thirty-sixth adult heart transplantation report - 2019; focus theme: Donor and recipient size match. J Heart Lung Transplant. 2019 Oct;38(10):1056-1066. doi: 10.1016/j.healun.2019.08.004. Epub 2019 Aug 10. No abstract available.

  PMID: 31548031 BACKGROUND

• Costanzo MR, Dipchand A, Starling R, Anderson A, Chan M, Desai S, Fedson S, Fisher P, Gonzales-Stawinski G, Martinelli L, McGiffin D, Smith J, Taylor D, Meiser B, Webber S, Baran D, Carboni M, Dengler T, Feldman D, Frigerio M, Kfoury A, Kim D, Kobashigawa J, Shullo M, Stehlik J, Teuteberg J, Uber P, Zuckermann A, Hunt S, Burch M, Bhat G, Canter C, Chinnock R, Crespo-Leiro M, Delgado R, Dobbels F, Grady K, Kao W, Lamour J, Parry G, Patel J, Pini D, Towbin J, Wolfel G, Delgado D, Eisen H, Goldberg L, Hosenpud J, Johnson M, Keogh A, Lewis C, O'Connell J, Rogers J, Ross H, Russell S, Vanhaecke J; International Society of Heart and Lung Transplantation Guidelines. The International Society of Heart and Lung Transplantation Guidelines for the care of heart transplant recipients. J Heart Lung Transplant. 2010 Aug;29(8):914-56. doi: 10.1016/j.healun.2010.05.034. No abstract available.

  PMID: 20643330 BACKGROUND

• Lund LH, Edwards LB, Kucheryavaya AY, Benden C, Dipchand AI, Goldfarb S, Levvey BJ, Meiser B, Rossano JW, Yusen RD, Stehlik J. The Registry of the International Society for Heart and Lung Transplantation: Thirty-second Official Adult Heart Transplantation Report--2015; Focus Theme: Early Graft Failure. J Heart Lung Transplant. 2015 Oct;34(10):1244-54. doi: 10.1016/j.healun.2015.08.003. Epub 2015 Aug 28. No abstract available.

  PMID: 26454738 BACKGROUND

Central Study Contacts

Georgina Fuertes, MD PHD

CONTACT

0034 976765500; georginaff@hotmail.com

Ainhoa Perez Guerrero, MD

CONTACT

ainhoaperezguerrero@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Fuertes

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: October 24, 2024
• Study Start: May 23, 2023
• Primary Completion (Estimated): May 23, 2028
• Study Completion (Estimated): October 14, 2028
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: October 2024
• Access Criteria: All researches/physicians involved in this investigational field

Locations

ES (2)