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.
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Eligibility Criteria
Inclusion Criteria:
≥18 years old NHL, HL or breast cancer diagnosis Scheduled to undergo chemotherapy including ≥ 240 mg/k2 cumulative dose of anthracyclines.
Pre-chemo LVEF \>40% on screening echocardiography.
Presence of ≥1 of the following risk factors for developing cardiotoxicity:
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Inclusion Criteria:
≥18 years old NHL, HL or breast cancer diagnosis Scheduled to undergo chemotherapy including ≥ 240 mg/k2 cumulative dose of anthracyclines.
Pre-chemo LVEF \>40% on screening echocardiography.
Presence of ≥1 of the following risk factors for developing cardiotoxicity:
Previous coronary artery disease (any of the following):
Previous coronary revascularisation (PCI or CABG) or Medical history of previous significant nonrevascularized coronary stenosis Previous Acute Coronary Syndrome / Acute Myocardial Infarction with a LVEF \> 40 LVEF 41-54% Age ≥ 65 years old Previous diagnosis of arterial hypertension (with or without treatment) Chronic kidney disease (estimated glomerular filtration rate \<60ml/min/1.73m2) Current or former smoker. Obesity (BMI≥30 kg/m2) LVH on screening echocardiography (LV thickness ≥12mm). High alcohol intake (≥21 alcoholic beverages per week) Sinus rhythm on screening ECG Previous diagnosis of diabetes (except those treated with sulfonylureas or those with neuropathy) Previous non-anthracycline-based chemotherapy Signed Informed Consent Form (ICF)
Exclusion Criteria:
* History of any of the following diseases:
* 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.
* Severe peripheral arterial disease in the upper extremities or arteriovenous (AV) shunt in the arm selected for RIPC.
* Clinical diagnosis of diabetes neuropathy
* Contraindication for CMR:
* Severe claustrophobia.
* Any device which is known to threaten or pose hazard in all MR environments (http://www.mrisafety.com/).
* Patients with implanted biomedical cardiac devices: pacemakers, ICDs or CRT.
* Severe thrombocytopenia (platelets \<50,000/µL) on any blood test within the previous 3 months.
* Patients participating in other clinical trials.
* Impossibility to consent or undergo study follow-ups.
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