Cost-utility Analysis of the AlloMap® Test

NCT ID: NCT02602691

Last Updated: 2023-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 197 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2022-10-28

Brief Summary

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.

Conditions

Heart Transplantation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Endomyocardial biopsy

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

Group Type: ACTIVE_COMPARATOR

Endomyocardial biopsies

Intervention Type: PROCEDURE

AlloMap® test

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

Group Type: EXPERIMENTAL

AlloMap®

Intervention Type: OTHER

Interventions

AlloMap®

Intervention Type: OTHER

Endomyocardial biopsies

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laurent SEBBAG, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

CHU, Hôpital du Haut Lévèque

Bordeaux, , France

CHU, Hôpital Michallon

La Tronche, , France

CHRU de Lille

Lille, , France

Hospices Civils de Lyon

Lyon, , France

CHU, Hôpital La Timone

Marseille, , France

CHU A. de Villeneuve

Montpellier, , France

CHU, Hôpital Nord Laennec

Nantes, , France

AP-HP, Hôpital Bichat

Paris, , France

AP-HP, Hôpital La Pitié Salpêtrière

Paris, , France

CHU de Rennes

Rennes, , France

CHU, Hôpital Charles Nicolle

Rouen, , France

CHRU de Strasbourg

Strasbourg, , France

CHU, Hôpital Rangueil

Toulouse, , France

Countries

France

Other Identifiers

IDRCB

Identifier Type: OTHER

Identifier Source: secondary_id

69HCL14_0455

Identifier Type: -

Identifier Source: org_study_id