REmote iSchemic condItioning in Lymphoma PatIents REceiving ANthraCyclinEs — RESILIENCE  

Lymphoma Clinical Trial

Official title: REmote iSchemic condItioning in Lymphoma PatIents REceiving ANthraCyclinEs

Status Recruiting

Clinical Trial Summary

Multinational, prospective, proof of concept phase II, double-blinded, sham-controlled, randomized clinical trial (RCT) to evaluate the efficacy and safety of Remote Ischaemic PreConditioning (RIPC) in Lymphoma patients receiving anthracyclines.

Clinical Trial Description

Multinational, prospective, proof of concept phase II, double-blinded, sham-controlled, randomized clinical trial (RCT) to evaluate the efficacy and safety of Remote Ischaemic PreConditioning (RIPC) in lymphoma patients receiving anthracyclines. Patients scheduled to undergo ≥5 chemotherapy cycles will be eligible. Patients fulfilling all inclusion and no exclusion criteria will be enrolled and undergo baseline Cardiac Magnetic Baseline (CMR), and high sensitivity troponin (hsTn) and NT-proBNP blood test. Patients with confirmed LVEF >40% by CMR will be randomized 1:1 to RIPC vs simulated RIPC (Sham). After the third chemotherapy cycle, a second CMR+ hsTn/ NT-proBNP will be performed for the validation of the early marker of cardiotoxicity. A third hsTn/ NT-proBNP blood test will be performed in the last chemotherapy cycle. Nine weeks after finishing chemotherapy, a last CMR+ hsTn/ NT-proBNP will be performed. Patients will be followed-up for clinical events at 6, 12, 18, 30 and 42 months until the last patient undergoes the final CMR. When the last patient undergoes the third CMR, the follow-up will be closed. The median follow-up estimation for clinical endpoints is 24 months (range: 6 to 42 months). ;

Related Conditions & MeSH terms

• Cardiotoxicity
• Lymphoma

• NCT number: NCT05223413
• Study type: Interventional
• Source: Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
• Contact: Borja Ibañez, MD PhD FESC
• Phone: 914501200
• Email: bibanez@cnic.es
• Status: Recruiting
• Phase: N/A
• Start date: January 18, 2022
• Completion date: May 2026