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REmote iSchemic condItioning in Lymphoma PatIents REceiving ANthraCyclinEs

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About this study

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.

Condition
Anthracycline-induced Cardiac Toxicity, Lymphoma
Tested
RIPC, Simulated RIPC (Sham)
Sponsor
Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III

Who can join

Age
18 to 99 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 10

  • Minimum age: 18 years
  • Maximum age: 99 years
  • Study condition: Anthracycline-induced Cardiac Toxicity, Lymphoma
  • ≥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 14

  • 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

24 sites, 24 recruiting

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

and 18 more sites on ClinicalTrials.gov

Contact

Potential match only. Final eligibility is determined by the study team.