REmote iSchemic condItioning in Lymphoma PatIents REceiving ANthraCyclinEs (RESILIENCE)

  • STATUS
    Recruiting
  • End date
    May 29, 2026
  • participants needed
    608
  • sponsor
    Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
Updated on 29 October 2022

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 Non-Hodgkin lymphoma (NHL) patients receiving anthracyclines.

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 Non-Hodgkin lymphoma (NHL) 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).

Details
Condition Anthracycline-induced Cardiac Toxicity, Non-Hodgkin Lymphoma
Treatment RIPC, Simulated RIPC (Sham)
Clinical Study IdentifierNCT05223413
SponsorFundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
Last Modified on29 October 2022

Eligibility

Yes No Not Sure

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
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
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 Signed Informed Consent Form (ICF)

Exclusion Criteria

History of any of the following diseases
Any cancer who received treatment
Previous clinical diagnosis of heart failure
Previous diagnosis of acute myocardial infarction
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
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
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