REmote iSchemic condItioning in Lymphoma PatIents REceiving ANthraCyclinEs (RESILIENCE)
Anthracycline-induced Cardiac Toxicity, Lymphoma
About this trial
This is an interventional prevention trial for Anthracycline-induced Cardiac Toxicity
Eligibility Criteria
Inclusion Criteria:
≥18 years old First NHL diagnosis Scheduled to undergo ≥5 chemotherapy cycles including anthracyclines. Pre-chemo LVEF >40% on screening echocardiography.
Presence of ≥1 of the following risk factors for developing cardiotoxicity:
- Previous coronary artery disease without evidence of prior myocardial infarction (any of the following):
- Previous coronary revascularisation (PCI or CABG)
- Medical history of previous significant non-revascularized coronary stenosis
- 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 Signed Informed Consent Form (ICF)
Exclusion Criteria:
History of any of the following diseases:
- Any cancer who received treatment
- Previous clinical diagnosis of heart failure.
- Previous diagnosis of acute myocardial infarction.
- 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
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.
Sites / Locations
- Aarhus UniversityRecruiting
- Henri BecquerelRecruiting
- University Hospital Duesseldorf UDUSRecruiting
- Amsterdam UMC
- Hospital da Luz Learning Health (GLSMED)Recruiting
- IPO LisboaRecruiting
- Instituto Catalán de OncologíaRecruiting
- Hospital Universitario Virgen de las NievesRecruiting
- Centro Nacional de Investigaciones Cardiovasculares (CNIC)Recruiting
- Fundacion Jimenez DiazRecruiting
- Hospital General Universitario Gregorio MarañonRecruiting
- Hospital Puerta de Hierro
- Hospital Universitario 12 de OctubreRecruiting
- Hospital Universitario Clínico San CarlosRecruiting
- Hospital Universitario la PazRecruiting
- Hospital Universitario Ramon y CajalRecruiting
- Hospital Universitario de SalamancaRecruiting
- Hospital Universitario Virgen del RocíoRecruiting
- Hospital Clinico Universitario de ValladolidRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Sham Comparator
Remote Ischemic Conditioning
simulated RIPC (Sham)
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
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.