REmote iSchemic condItioning in Lymphoma PatIents REceiving ANthraCyclinEs (RESILIENCE)

Phase 2

Conditions: lymphoma
Non Hodgkin Lymphoma
10025322

Registration Number: NL-OMON56231

Lead Sponsor: Centro Nacional de Investigaciones Cardiovasculares Carlos III (CNIC)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 70

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

- 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