Remote Ischemic Conditioning for Lymphoma Patients Receiving Chemotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Aarhus University
  Aarhus, Denmark Recruiting
• Henri Becquerel
  Rouen, France Recruiting
• University Hospital Duesseldorf UDUS
  Düsseldorf, Germany Recruiting
• Hospital da Luz Learning Health (GLSMED)
  Lisbon, Portugal Recruiting
• IPO Lisboa
  Lisbon, Portugal Recruiting
• Centro Medico Teknon
  Barcelona, Spain Recruiting

Study contacts

• Principal investigator: Borja Ibañez, MD PhD FESC — Cnic
• Study coordinator: Borja Ibañez, MD PhD FESC
• Email: bibanez@cnic.es
• Phone: 914501200

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.