REmote iSchemic condItioning in Lymphoma PatIents REceiving ANthraCyclinEs
RESILIENCE
1 other identifier
interventional
608
6 countries
24
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2022
Longer than P75 for not_applicable
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 20, 2021
CompletedStudy Start
First participant enrolled
January 18, 2022
CompletedFirst Posted
Study publicly available on registry
February 4, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
September 18, 2025
May 1, 2025
4.4 years
December 20, 2021
September 12, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Rate of anthracycline-induced cardiotoxicity events
Cardiotoxicity event is defined as one of the following: * Drop in LVEF between study CMRs of ≥10 absolute points regardless the absolute value of follow- up ejection fraction (EF). * Drop in LVEF between study CMRs of ≥5 to \<10 absolute points with a follow-up EF value \<50% UNITS: absolute number of patients in each arm qualifying for cardiotoxicity event (i.e. each patient will be qualified at the end of the study as YES/NO).
9 weeks after the last chemotherapy cycle (anticipated to be between 150 and 200 days from enrollment)
Secondary Outcomes (6)
Primary efficacy endpoint: (RIC vs Sham) Absolute change in LVEF
9 weeks after the last chemotherapy cycle (anticipated to be between 150 and 200 days from enrollment)
Rate of tumor regression.
9 weeks after the last chemotherapy cycle (anticipated to be between 150 and 200 days from enrollment)
Change in Quality of Life-Haematological Malignancy Patient-Reported Outcome Measure questionnaire
9 weeks after the last chemotherapy cycle (anticipated to be between 150 and 200 days from enrollment)
Change in Quality of Life-Euro Quality of Life-5 dimensions questionnaire
9 weeks after the last chemotherapy cycle (anticipated to be between 150 and 200 days from enrollment)
Change in Quality of Life-Kansas City Cardiomyopathy Questionnaire
9 weeks after the last chemotherapy cycle (anticipated to be between 150 and 200 days from enrollment)
- +1 more secondary outcomes
Study Arms (2)
Remote Ischemic Conditioning
ACTIVE COMPARATORRemote 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
simulated RIPC (Sham)
SHAM COMPARATORControl 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.
Interventions
The procedure will be performed by using an electric auto-control device (modified blood pressure monitor for remote ischemic conditioning, Seagull Healthcare Aps, Denmark) for Remote Ischemic Conditioning in the arm. During the inflation period, the blood pressure cuff is inflated to 200 mmHg to stop blood flow in the arm.
The procedure will be performed by using an electric auto-control device (modified blood pressure monitor for remote ischemic conditioning, Seagull Healthcare Aps, Denmark) for Remote Ischemic Conditioning in the arm. During the inflation period, the blood pressure cuff is inflated to a low pressure not stopping blood flow in the arm.
Eligibility Criteria
You may qualify if:
- ≥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)
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Aarhus University
Aarhus, Denmark
Hospital Jaques Monod, El Havre
Montivilliers, France
Henri Becquerel
Rouen, France
University Hospital Duesseldorf UDUS
Düsseldorf, Germany
Amsterdam UMC
Amsterdam, Netherlands
Hospital da Luz Learning Health (GLSMED)
Lisbon, Portugal
IPO Lisboa
Lisbon, Portugal
Hospital Universitario Príncipe de Asturias
Alcalá de Henares, Spain
Centro Medico Teknon
Barcelona, Spain
Instituto Catalán de Oncología
Barcelona, Spain
Hospital Universitario Virgen de las Nieves
Granada, Spain
Centro Nacional de Investigaciones Cardiovasculares (CNIC)
Madrid, Spain
Fundacion Jimenez Diaz
Madrid, Spain
Hospital General Universitario Gregorio Marañon
Madrid, Spain
Hospital Infanta Leonor
Madrid, Spain
Hospital Puerta de Hierro
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario Clínico San Carlos
Madrid, Spain
Hospital Universitario la Paz
Madrid, Spain
Hospital Universitario Ramon y Cajal
Madrid, Spain
Hospital Universitario Ruber Juan Bravo
Madrid, Spain
Hospital Universitario de Salamanca
Salamanca, Spain
Hospital Universitario Virgen del Rocío
Seville, Spain
Hospital Clinico Universitario de Valladolid
Valladolid, Spain
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Borja Ibañez, MD PhD FESC
CNIC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 20, 2021
First Posted
February 4, 2022
Study Start
January 18, 2022
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
September 18, 2025
Record last verified: 2025-05