Cost-utility Analysis of the AlloMap® Test

Heart Transplantation Clinical Trial

— CUPIDON  

Official title:

Cost-utility Analysis of the AlloMap® Test for the Monitoring of Patients After Heart Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02602691
• Other study ID #: 69HCL14_0455
• Secondary ID: IDRCB
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: October 28, 2022

Study information

• Verified date: August 2023
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 197
• Est. completion date: October 28, 2022
• Est. primary completion date: October 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Transplantation

Intervention

Other:
• AlloMap®

Procedure:
• Endomyocardial biopsies

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	QALY will be measured using the EQ-5D quality of life questionnaire. The cost analysis will be conducted from the viewpoints of the French Health Insurance and the hospital, considering only hospital direct costs. All resource consumption, outside the AlloMap® test, will be commonly valued by standard costs.	36 months after heart transplantation
Secondary	Budget Impact analysis: estimation of the cost difference of the care of heart transplant patients before and after the introduction of the AlloMap® test	Estimation of the cost difference of the care of heart transplant patients from the viewpoint of the French Health Insurance between two situations: The current situation before the introduction of the innovative strategy: to estimate the overall cost in monitoring of heart transplant patients in France.; A hypothetical situation after the introduction of the innovative strategy: the impact of the introduction of the innovative strategy in the care of heart transplant patients must be simulated and the cost for this new situation must be estimated.	36 months after heart transplantation
Secondary	Quality of life	Quality of life coefficient will be estimated with the EQ-5D questionnaire	At inclusion visit (5 months after heart transplantation)
Secondary	Quality of life	Quality of life coefficient will be estimated with the EQ-5D questionnaire	At 12 months after heart transplantation
Secondary	Quality of life	Quality of life coefficient will be estimated with the EQ-5D questionnaire	At 18 months after heart transplantation
Secondary	Quality of life	Quality of life coefficient will be estimated with the EQ-5D questionnaire	At 24 months after heart transplantation
Secondary	Quality of life	Quality of life coefficient will be estimated with the EQ-5D questionnaire	At 30 months after heart transplantation
Secondary	Quality of life	Quality of life coefficient will be estimated with the EQ-5D questionnaire	At 36 months after heart transplantation
Secondary	Number of endomyocardial biopsies between the sixth and the thirty-sixth months after heart transplantation		30 months
Secondary	Number and types of complications secondary to endomyocardial biopsies between the sixth and the thirty-sixth months after heart transplantation		30 months
Secondary	Number of treated cell transplant rejection between the sixth and the thirty-sixth months after heart transplantation	Global number and number per ISHLT grade	30 months
Secondary	Number of treated humoral transplant rejection between the sixth and the thirty-sixth months after heart transplantation		30 months
Secondary	Number of transplant rejection with hemodynamic consequences between the sixth and the thirty-sixth months after heart transplantation		30 months
Secondary	Number of transplant rejection proven by endomycardial biopsy between the sixth and the thirty-sixth months after heart transplantation		30 months
Secondary	Global survival		36 months after heart transplantation
Secondary	Survival without transplant rejection		36 months after heart transplantation
Secondary	Survival without graft dysfunction	Dysfunction will be defined with ejection fraction =30% on echocardiogram	36 months after heart transplantation