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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02602691
Recruitment Status : Active, not recruiting
First Posted : November 11, 2015
Last Update Posted : October 26, 2020
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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.


Condition or disease Intervention/treatment Phase
Heart Transplantation Other: AlloMap® Procedure: Endomyocardial biopsies Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 188 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Cost-utility Analysis of the AlloMap® Test for the Monitoring of Patients After Heart Transplantation
Actual Study Start Date : April 2016
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Endomyocardial biopsy
Systematic endomyocardial biopsies performed according to a planned monitoring schedule in usual care for patients with a heart transplantation.
Procedure: Endomyocardial biopsies
Experimental: 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.
Other: AlloMap®



Primary Outcome Measures :
  1. 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 [ Time Frame: 36 months after heart transplantation ]
    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.


Secondary Outcome Measures :
  1. Budget Impact analysis: estimation of the cost difference of the care of heart transplant patients before and after the introduction of the AlloMap® test [ Time Frame: 36 months after heart transplantation ]

    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.

  2. Quality of life [ Time Frame: At inclusion visit (5 months after heart transplantation) ]
    Quality of life coefficient will be estimated with the EQ-5D questionnaire

  3. Quality of life [ Time Frame: At 12 months after heart transplantation ]
    Quality of life coefficient will be estimated with the EQ-5D questionnaire

  4. Quality of life [ Time Frame: At 18 months after heart transplantation ]
    Quality of life coefficient will be estimated with the EQ-5D questionnaire

  5. Quality of life [ Time Frame: At 24 months after heart transplantation ]
    Quality of life coefficient will be estimated with the EQ-5D questionnaire

  6. Quality of life [ Time Frame: At 30 months after heart transplantation ]
    Quality of life coefficient will be estimated with the EQ-5D questionnaire

  7. Quality of life [ Time Frame: At 36 months after heart transplantation ]
    Quality of life coefficient will be estimated with the EQ-5D questionnaire

  8. Number of endomyocardial biopsies between the sixth and the thirty-sixth months after heart transplantation [ Time Frame: 30 months ]
  9. Number and types of complications secondary to endomyocardial biopsies between the sixth and the thirty-sixth months after heart transplantation [ Time Frame: 30 months ]
  10. Number of treated cell transplant rejection between the sixth and the thirty-sixth months after heart transplantation [ Time Frame: 30 months ]
    Global number and number per ISHLT grade

  11. Number of treated humoral transplant rejection between the sixth and the thirty-sixth months after heart transplantation [ Time Frame: 30 months ]
  12. Number of transplant rejection with hemodynamic consequences between the sixth and the thirty-sixth months after heart transplantation [ Time Frame: 30 months ]
  13. Number of transplant rejection proven by endomycardial biopsy between the sixth and the thirty-sixth months after heart transplantation [ Time Frame: 30 months ]
  14. Global survival [ Time Frame: 36 months after heart transplantation ]
  15. Survival without transplant rejection [ Time Frame: 36 months after heart transplantation ]
  16. Survival without graft dysfunction [ Time Frame: 36 months after heart transplantation ]
    Dysfunction will be defined with ejection fraction ≤30% on echocardiogram



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02602691


Locations
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France
Hospices Civils de Lyon
Lyon, France
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Laurent SEBBAG, MD Hospices Civils de Lyon
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02602691    
Other Study ID Numbers: 69HCL14_0455
IDRCB ( Other Identifier: 2015-A00808-41 )
First Posted: November 11, 2015    Key Record Dates
Last Update Posted: October 26, 2020
Last Verified: October 2020
Keywords provided by Hospices Civils de Lyon:
Heart transplantation
AlloMap® gene expression profiling test
Medico-economic study