Phase II Study of Remote Ischemic Conditioning to Prevent Heart Damage in Lymphoma Patients Receiving Anthracycline Chemotherapy

What this Trial Is About

Researchers are evaluating the safety and effectiveness of Remote Ischemic PreConditioning RIPC in lymphoma patients receiving anthracycline chemotherapy. This multinational, phase II, randomized clinical trial compares RIPC to a sham procedure to understand its impact on preventing heart damage caused by anthracyclines. The study includes patients scheduled for at least five chemotherapy cycles and uses heart imaging and blood tests to monitor heart function. Participants will be randomly assigned to either the RIPC group or the sham control group. The RIPC group will undergo weekly sessions of blood pressure cuff inflation on the arm, with four cycles of 5 minutes inflation at 200 mmHg followed by 5 minutes deflation during the entire chemotherapy period. The sham group will receive similar weekly sessions but with low pressure that does not stop blood flow. The study includes baseline heart MRI and biomarker tests before chemotherapy, repeated after the third chemotherapy cycle, at the last chemotherapy cycle, and nine weeks post-chemotherapy. Throughout the study, participants will have heart function evaluated using cardiac magnetic resonance imaging and blood tests for heart injury markers. Follow-up visits will occur to monitor clinical events for up to 42 months after treatment ends, with a median follow-up of 36 months. The main outcome measured is the rate of heart damage events related to anthracycline use, assessed nine weeks after finishing chemotherapy.

REmote iSchemic condItioning in Lymphoma PatIents REceiving ANthraCyclinEs