Remote Ischemic Conditioning for Lymphoma Patients Receiving Chemotherapy

REmote iSchemic condItioning in Lymphoma PatIents REceiving ANthraCyclinEs

This study is testing if a special treatment called Remote Ischemic Preconditioning can help protect the hearts of lymphoma patients from damage while they receive chemotherapy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 608 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 24 sites (Aarhus and 23 other locations)
• Trial ID: NCT05223413 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of Remote Ischemic Preconditioning (RIPC) in lymphoma patients undergoing treatment with anthracyclines. It is a multinational, double-blinded, sham-controlled, randomized trial involving patients who are scheduled to receive at least five chemotherapy cycles. Participants will undergo cardiac assessments, including Cardiac Magnetic Resonance imaging and blood tests for cardiac biomarkers, at various points during and after chemotherapy to monitor for signs of cardiac toxicity. The study aims to determine if RIPC can mitigate the risk of anthracycline-induced cardiac damage.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a first diagnosis of lymphoma who are scheduled for at least five cycles of anthracycline chemotherapy and have a left ventricular ejection fraction greater than 40%.

Not a fit: Patients who do not have a first lymphoma diagnosis or those with a left ventricular ejection fraction below 40% will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risk of cardiac toxicity in lymphoma patients receiving anthracycline chemotherapy.

How similar studies have performed: While the concept of Remote Ischemic Preconditioning has been explored in other contexts, this specific application in lymphoma patients receiving anthracyclines is novel and has not been extensively tested.

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.

Where this trial is running

Aarhus and 23 other locations

• Aarhus University — Aarhus, Denmark (Recruiting)
• Hospital Jaques Monod, El Havre — Montivilliers, France (Not_yet_recruiting)
• Henri Becquerel — Rouen, France (Recruiting)
• University Hospital Duesseldorf UDUS — Düsseldorf, Germany (Recruiting)
• Amsterdam UMC — Amsterdam, Netherlands (Not_yet_recruiting)
• Hospital da Luz Learning Health (GLSMED) — Lisbon, Portugal (Recruiting)
• IPO Lisboa — Lisbon, Portugal (Recruiting)
• Hospital Universitario Príncipe de Asturias — Alcalá de Henares, Spain (Not_yet_recruiting)
• Centro Medico Teknon — Barcelona, Spain (Recruiting)
• Instituto Catalán de Oncología — Barcelona, Spain (Recruiting)
• Hospital Universitario Virgen de las Nieves — Granada, Spain (Recruiting)
• Centro Nacional de Investigaciones Cardiovasculares (CNIC) — Madrid, Spain (Recruiting)
• Fundacion Jimenez Diaz — Madrid, Spain (Recruiting)
• Hospital General Universitario Gregorio Marañon — Madrid, Spain (Recruiting)
• Hospital Infanta Leonor — Madrid, Spain (Recruiting)
• Hospital Puerta de Hierro — Madrid, Spain (Recruiting)
• Hospital Universitario 12 de Octubre — Madrid, Spain (Recruiting)
• Hospital Universitario Clínico San Carlos — Madrid, Spain (Recruiting)
• Hospital Universitario la Paz — Madrid, Spain (Recruiting)
• Hospital Universitario Ramon y Cajal — Madrid, Spain (Recruiting)
• Hospital Universitario Ruber Juan Bravo — Madrid, Spain (Recruiting)
• Hospital Universitario de Salamanca — Salamanca, Spain (Recruiting)
• Hospital Universitario Virgen del Rocío — Seville, Spain (Recruiting)
• Hospital Clinico Universitario de Valladolid — Valladolid, Spain (Recruiting)

Study contacts

• Principal investigator: Borja Ibañez, MD PhD FESC — Cnic
• Study coordinator: Borja Ibañez, MD PhD FESC

Conditions Anthracycline-induced Cardiac Toxicity; Lymphoma