1. Primary efficacy endpoint: (RIC vs Sham) Absolute change in LVEF (Time Frame - 9 weeks after the last chemotherapy cycle (anticipated to be between 150 and 200 days from enrollment)): change in LVEF between baseline and any follow-up CMRs, whichever shows worse LVEF
UNITS: LVEF is expressed as % LVEF= (LV end-diastolic volume - LV end-systolic volume) / LV end-systolic volume), %
Secondary outcome:
1. Rate of anthracycline-induced cardiotoxicity events (Time Frame - 9 weeks after the last chemotherapy cycle (anticipated to be between 150 and 200 days from enrollment)): Cardiotoxicity event is defined as one of the following:
Drop in LVEF between study CMRs of ≥10 absolute points regardless the absolute value of follow- up ejection fraction (EF).
Drop in LVEF between study CMRs of ≥5 to <10 absolute points with a follow-up EF value <50%
UNITS: absolute number of patients in each arm qualifying for cardiotoxicity event (i.e. each patient will be qualified at the end of the study as YES/NO).
2. Rate of tumor regression. (Time Frame - 9 weeks after the last chemotherapy cycle (anticipated to be between 150 and 200 days from enrollment)): Response to chemotherapy
UNITS: absolute number of patients in each arm qualifying as responder or no responder (i.e. each patient will be qualified at the end of the study as YES/NO).
3. Change in Quality of Life-Haematological Malignancy Patient-Reported Outcome Measure questionnaire (Time Frame - 9 weeks after the last chemotherapy cycle (anticipated to be between 150 and 200 days from enrollment)): Haematological Malignancy Patient-Reported Outcome Measure (HM-PRO) questionnaire
UNITS: absolute points in the questionnaire. minimum value 0 maximum value 84
the higher the total score, the better (greater the effect on a patient's QoL)
4. Change in Quality of Life-Euro Quality of Life-5 dimensions questionnaire (Time Frame - 9 weeks after the last chemotherapy cycle (anticipated to be between 150 and 200 days from enrollment)): Euro Quality of Life-5 dimensions (EuroQoL-5D) questionnaire:
UNITS: absolute points in the questionnaire. minimum value 0 maximum value 100
the higher the total score, the better (greater the effect on a patient's QoL)
5. Change in Quality of Life-Kansas City Cardiomyopathy Questionnaire (Time Frame - 9 weeks after the last chemotherapy cycle (anticipated to be between 150 and 200 days from enrollment)): Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
UNITS: absolute points in the questionnaire. minimum value 0 maximum value 65
the higher the total score, the better (greater the effect on a patient's QoL)
6. Rate of Heart Failure Hospitalization (Time Frame - 6-42 months): Rate of Heart Failure Hospitalization
UNITS: Absolute number of patients in each arm experiencing a heart failure hospitalization
Active Comparator: Remote Ischemic Conditioning Remote Ischemic Conditioning (RIC): Patients will undergo weekly RIC during the entire span of the chemotherapy period. Each RIC session will include four cycles of 5 min blood pressure cuff inflation followed by 5 min deflation
Sham Comparator: simulated RIPC (Sham) Control group (Sham): Patients will undergo weekly simulated RIC (sham) during the entire span of the chemotherapy period. Each sham session will include four cycles of 5 min blood pressure cuff inflation followed by 5 min deflation.
RIPC: The procedure will be performed by using an electric auto-control device (modified blood pressure monitor for remote ischemic conditioning, Seagull Healthcare Aps, Denmark) for Remote Ischemic Conditioning in the arm. During the inflation period, the blood pressure cuff is inflated to 200 mmHg to stop blood flow in the arm.
Simulated RIPC (Sham): The procedure will be performed by using an electric auto-control device (modified blood pressure monitor for remote ischemic conditioning, Seagull Healthcare Aps, Denmark) for Remote Ischemic Conditioning in the arm. During the inflation period, the blood pressure cuff is inflated to a low pressure not stopping blood flow in the arm.
Quelle: ClinicalTrials.gov
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