Multinational, prospective, proof of concept phase II, double-blinded, sham-controlled, randomized clinical trial (RCT) to evaluate the efficacy and safety of Remote Ischaemic PreConditioning (RIPC) in Lymphoma patients receiving anthracyclines.
None
Any cancer who received anthracyclines treatment before the index episode.
Previous clinical diagnosis of heart failure.
Permanent atrial fibrillation (AF).
Severe valvular or sub-valvular heart disease.
Parallel
RIPC
DeviceThe 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)
DeviceThe 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.
Rate of anthracycline-induced cardiotoxicity events
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).
Primary efficacy endpoint: (RIC vs Sham) Absolute change in LVEF
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), %
Rate of tumor regression.
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).
Change in Quality of Life-Haematological Malignancy Patient-Reported Outcome Measure questionnaire
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)
Change in Quality of Life-Euro Quality of Life-5 dimensions questionnaire
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)
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Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
Lead sponsor
European Commission
Collaborator
