Non Hodgkin Lymphoma
Conditions
Interventions
Intervention is RIC vs simulated RIC (Sham)
The procedure will be performed by using an electric auto-control device for remote ischemic conditioning (RIC) or simulated RIC (Sham) in the upper limb.
Sponsors
Centro Nacional de Investigaciones Cardiovasculares Carlos III (CNIC)
Eligibility
Age
18 Years to 99 Years
Inclusion 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: o 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 o LVEF 41-54% o Age >= 65 years old o Previous diagnosis of arterial hypertension (with or without treatment) o Chronic kidney disease (estimated glomerular filtration rate < 60ml/min/1.73m2) o Current or former smoker. o Obesity (BMI>=30 kg/m2) o LVH on screening echocardiography (LV thickness >=12mm). o High alcohol intake (>=21 alcoholic beverages per week) - Sinus rhythm on screening ECG
Exclusion criteria
Exclusion criteria: - History of any of the following diseases: o Any cancer who received anthracyclines treatment before the index episode o Previous clinical diagnosis of heart failure. o Previous diagnosis of acute myocardial infarction. o Permanent atrial fibrillation (AF). o Severe valvular or sub-valvular heart disease, either as a previously clinical diagnosis or as a finding on screening echocardiography. o Severe peripheral arterial disease in the upper extremities or arteriovenous (AV) shunt in the arm selected for RIC. - Clinical diagnosis of diabetes, with or without treatment. - Contraindication for contrast enhanced CMR - Severe thrombocytopenia (platelet <50) on any blood test within the previous 3 months. - Patients participating in other randomized clinical trials. - Impossibility to consent or undergo study follow-ups
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of Anthracycline-induced cardiotoxicity events (based on drop in LVEF between baseline and any CMR of the 2 follow-up CMRs, whichever shows lower LVEF). 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 EF.? Drop in LVEF between study CMRs of =5 to <10 absolute points with a followup EF value <50% | — |
Secondary
| Measure | Time frame |
|---|---|
| Absolute change in LVEF (between baseline and any follow up CMRs, whichever shows worse LVEF. Rate of atrial fibrillation. Rate of hospital admission for sustained ventricular tachycardia, ventricular fibrillation (VT/VF) or resuscitated cardiac arrest. Time to all cause death Time to HF hospitalization Rate of tumour regression. Change in Quality of Life (QOL, scores in questionnaires) between baseline and 2 time-points (after 3rd chemotherapy cycle, and 9 weeks after the last chemotherapy cycle). | — |
Countries
Denmark, France, Germany, Netherlands, Portugal, Spain
Contacts
Public ContactK. Heer
Amsterdam UMC
Outcome results
None listed