Clinical trial · Interventional
REmote iSchemic condItioning in Lymphoma PatIents REceiving ANthraCyclinEs
NCT05223413CI-TRIAL-00095396RESILIENCErecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anthracycline-induced Cardiac Toxicity | — | UNRESOLVED | — |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RIPC | Device | — | UNRESOLVED |
| Simulated RIPC (Sham) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Remote Ischemic Conditioning
- description
- Remote Ischemic Conditioning (RIC): Patients will undergo weekly RIC during the entire span of the chemotherapy period. Each RIC session will include four cycles of 5 min blood pressure cuff inflation followed by 5 min deflation
- interventionNames
- Device: RIPC
- type
- SHAM_COMPARATOR
- label
- simulated RIPC (Sham)
- description
- Control group (Sham): Patients will undergo weekly simulated RIC (sham) during the entire span of the chemotherapy period. Each sham session will include four cycles of 5 min blood pressure cuff inflation followed by 5 min deflation.
- interventionNames
- Device: Simulated RIPC (Sham)
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.