Cost-utility Analysis of the AlloMap® Test (CUPIDON)

Civil Hospices of Lyon

Status: Completed

Conditions: Heart Transplantation

Treatments: Other: AlloMap®; Procedure: Endomyocardial biopsies

Study type: Interventional

Funder types: Other

Identifiers

NCT02602691

69HCL14_0455

IDRCB (Other Identifier)

Details and patient eligibility

About

Transplant rejection is one of the most important complications of heart transplantation and requires a specific monitoring, including regular and invasive endomyocardial biopsies.

The average hospital cost of a biopsy has been estimated at 3 297 dollars in United States. In France, the reimbursement rates by the Health Insurance for the corresponding stays vary from 682 to 25 865 euros, according to the finding of a rejection and its severity.

AlloMap® is a non-invasive blood test that can identify patients with low probability of moderate to severe acute cell transplant rejection. The non-inferiority of the use of the AlloMap® test has been demonstrated in comparison of the usual care in terms of diagnosis of acute cellular rejection in a randomized study conducted in the United States. Following this study, the ISHLT (International Society of Heart and Lung Transplantation) made recommendations advocating its use for these patients between 6 months and 5 years after heart transplantation. This new test could be an alternative to systematic biopsies usually performed to patients whose allograft function is stable, but it is very expensive since the analysis of a blood sample cost 2 000 euros pre-tax in France. This cost has to be compared with the current patient care. By replacing biopsies performed systematically, the test should reduce the costs of full and day hospitalizations for the realization of biopsies but also the costs associated with their possible complications. In addition, it can be expected that its use provides a benefit to the patient in terms of quality of life. Indeed, the achievement of a biopsy may cause significant stress and anxiety for the patient, due to discomfort, pain and potential complications that may be severe.

To this day, no medico-economic assessment has been conducted to prove the interest of the use of AlloMap® compared to systematic realization of endomyocardial biopsies. The purpose of the CUPIDON study is to assess the effectiveness of the use of the AlloMap® test for monitoring heart transplant patients in the context of usual care and in accordance with international recommendations. AlloMap® will be used and compared to the current surveillance strategy by endomyocardial biopsies from 6 months to 36 months after heart transplantation. The investigators hypothesize that the use of this test for the diagnosis of acute cellular transplant rejection would avoid the costs of a large number of biopsies, while increasing the quality of life of patients related to their health.

Enrollment: 197 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years old

• Heart transplantation since 5 months (+/- 3 weeks)

• Stable allograft function :

  • Left ventricular ejection fraction ≥ 50% measured by echocardiography
  • No sign of the presence of humoral rejection or DSA (donor-specific antibodies)
  • Absence of biopsy-proven or treated acute cellular rejection in the previous 3 months

• Signed consent to participate in the study

• Patient affiliated to a social security scheme or similar

Exclusion criteria

• All symptoms or clinical signs of graft failure
• Treatment of a transplant rejection with ISHLT grade 2R or higher (proven by biopsy) during the previous 3 months
• Change of immunosuppressive molecule in the previous 30 days
• Treatment with hematopoietic growth factors in progress or during the previous 30 days
• Corticosteroid dose > 20 mg / day prednisone equivalent at the time of inclusion
• Transfusion during the previous 30 days
• End-stage renal failure requiring renal replacement therapy (hemodialysis or peritoneal dialysis)
• Pregnant woman at the time of inclusion
• Major patient protected by law

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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197 participants in 2 patient groups

Endomyocardial biopsy

Active Comparator group

Description:

Systematic endomyocardial biopsies performed according to a planned monitoring schedule in usual care for patients with a heart transplantation.

Treatment:

Procedure: Endomyocardial biopsies

AlloMap® test

Experimental group

Description:

Noninvasive gene expression profiling blood test (AlloMap®) performed instead of endomyocardial biopsies when planned in the monitoring schedule for patients with a heart transplantation.

Treatment:

Other: AlloMap®