NCT05223413 REmote iSchemic condItioning in Lymphoma PatIents REceiving ANthraCyclinEs
| NCT ID | NCT05223413 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III |
| Condition | Anthracycline-induced Cardiac Toxicity |
| Study Type | INTERVENTIONAL |
| Enrollment | 608 participants |
| Start Date | 2022-01-18 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 608 participants in total. It began in 2022-01-18 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: ≥18 years old NHL, HL or breast cancer diagnosis Scheduled to undergo chemotherapy including ≥ 240 mg/k2 cumulative dose of 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.
Contact & Investigator
Borja Ibañez, MD PhD FESC
PRINCIPAL INVESTIGATOR
CNIC
Frequently Asked Questions
Who can join the NCT05223413 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Anthracycline-induced Cardiac Toxicity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05223413 currently recruiting?
Yes, NCT05223413 is actively recruiting participants. Contact the research team at bibanez@cnic.es for enrollment information.
Where is the NCT05223413 trial being conducted?
This trial is being conducted at Aarhus, Denmark, Montivilliers, France, Rouen, France, Düsseldorf, Germany and 11 additional locations.
Who is sponsoring the NCT05223413 clinical trial?
NCT05223413 is sponsored by Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III. The principal investigator is Borja Ibañez, MD PhD FESC at CNIC. The trial plans to enroll 608 participants.