Clinical trial NCT02602691: Cost-utility Analysis of the AlloMap® Test
Official title: Cost-utility Analysis of the AlloMap® Test for the Monitoring of Patients After Heart Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Transplantation
Keywords: Heart transplantation
AlloMap® gene expression profiling test
Medico-economic study
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2015-11-11
Enrollment: 197
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Incremental cost per quality-adjusted life-years (QALY) between systematic biopsies and use of the gene expression profiling blood test AlloMap® in monitoring of heart transplant patients for rejection
timeFrame: 36 months after heart transplantation
Secondary outcomes:
measure: Budget Impact analysis: estimation of the cost difference of the care of heart transplant patients before and after the introduction of the AlloMap® test
timeFrame: 36 months after heart transplantation
measure: Quality of life
timeFrame: At inclusion visit (5 months after heart transplantation)
measure: Quality of life
timeFrame: At 12 months after heart transplantation
measure: Quality of life
timeFrame: At 18 months after heart transplantation
measure: Quality of life
timeFrame: At 24 months after heart transplantation
measure: Quality of life
timeFrame: At 30 months after heart transplantation
measure: Quality of life
timeFrame: At 36 months after heart transplantation
measure: Number of endomyocardial biopsies between the sixth and the thirty-sixth months after heart transplantation
timeFrame: 30 months
measure: Number and types of complications secondary to endomyocardial biopsies between the sixth and the thirty-sixth months after heart transplantation
timeFrame: 30 months
measure: Number of treated cell transplant rejection between the sixth and the thirty-sixth months after heart transplantation
timeFrame: 30 months
measure: Number of treated humoral transplant rejection between the sixth and the thirty-sixth months after heart transplantation
timeFrame: 30 months
measure: Number of transplant rejection with hemodynamic consequences between the sixth and the thirty-sixth months after heart transplantation
timeFrame: 30 months
measure: Number of transplant rejection proven by endomycardial biopsy between the sixth and the thirty-sixth months after heart transplantation
timeFrame: 30 months
measure: Global survival
timeFrame: 36 months after heart transplantation
measure: Survival without transplant rejection
timeFrame: 36 months after heart transplantation
measure: Survival without graft dysfunction
timeFrame: 36 months after heart transplantation
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU, Hôpital du Haut Lévèque
city: La Tronche
country: France
facility: CHU, Hôpital Michallon
city: Lille
country: France
facility: CHRU de Lille
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Marseille
country: France
facility: CHU, Hôpital La Timone
city: Montpellier
country: France
facility: CHU A. de Villeneuve
city: Nantes
country: France
facility: CHU, Hôpital Nord Laennec
city: Paris
country: France
facility: AP-HP, Hôpital Bichat
city: Paris
country: France
facility: AP-HP, Hôpital La Pitié Salpêtrière
city: Rennes
country: France
facility: CHU de Rennes
city: Rouen
country: France
facility: CHU, Hôpital Charles Nicolle
city: Strasbourg
country: France
facility: CHRU de Strasbourg
city: Toulouse
country: France
facility: CHU, Hôpital Rangueil
Study officials:
affiliation: Hospices Civils de Lyon
name: Laurent SEBBAG, MD
role: PRINCIPAL_INVESTIGATOR
References: