REmote iSchemic condItioning in Lymphoma PatIents REceiving ANthraCyclinEs

Launched by FUNDACIÓN CENTRO NACIONAL DE INVESTIGACIONES CARDIOVASCULARES CARLOS III · Feb 2, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at a method called Remote Ischaemic Preconditioning (RIPC) to see if it can help protect the hearts of lymphoma patients who are receiving a type of chemotherapy called anthracyclines. Anthracyclines can sometimes cause heart problems, and this study aims to determine if RIPC can reduce those risks. The trial is open to adults aged 18 and older who are starting their first treatment for lymphoma and are scheduled to receive at least five chemotherapy cycles that include anthracyclines. To be eligible, participants must have a healthy heart function at the start of the study and have certain risk factors for heart issues, such as being over 65 years old, having a history of high blood pressure, or being a smoker.

If you decide to participate, you can expect to be randomly assigned to either the RIPC treatment group or a control group that does not receive the active treatment. The study is designed to be double-blinded, meaning neither you nor the researchers will know which group you are in to ensure fair testing. Participants will also need to provide informed consent and attend regular follow-up appointments. It’s important to note that there are certain health conditions that may exclude someone from participating, such as severe heart disease or being involved in other clinical trials. This research could help improve care for lymphoma patients in the future by finding ways to protect their hearts during chemotherapy.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • ≥18 years old First Lymphoma 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 (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.