REmote iSchemic condItioning in Lymphoma PatIents REceiving ANthraCyclinEs
NCT ID: NCT05223413
Last Updated: 2025-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
608 participants
INTERVENTIONAL
2022-01-18
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Remote Ischemic Conditioning
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
RIPC
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.
simulated RIPC (Sham)
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.
Simulated RIPC (Sham)
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.
Interventions
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RIPC
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.
Simulated RIPC (Sham)
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
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Inclusion Criteria
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
* 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.
18 Years
99 Years
ALL
No
Sponsors
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European Commission
OTHER
Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
OTHER
Responsible Party
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Principal Investigators
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Borja Ibañez, MD PhD FESC
Role: PRINCIPAL_INVESTIGATOR
CNIC
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Francesco Damore
Role: primary
Pierre Lebreton
Role: primary
Vincent Camus
Role: primary
Florian Boenner
Role: primary
Marie Jose Kersten
Role: primary
Antonio Ferreira
Role: primary
Maria Gomes
Role: primary
Julio García Suarez
Role: primary
Antonio Berruezo
Role: primary
Eva Gonzalez
Role: primary
Jose Manuel Puerta
Role: primary
Borja Ibañez
Role: primary
Raul Córdoba
Role: primary
Mariana Bastos
Role: primary
Jose Angel Hernandez Rivas
Role: primary
Belen Navarro
Role: primary
Ana Jimenez
Role: primary
Celina Benavente
Role: primary
Miguel Canales
Role: primary
Javier Lopez
Role: primary
Aranzazu Alonso Alonso
Role: primary
Alejandro Martin
Role: primary
Guillermo Rodriguez
Role: primary
Maria Jesús Peñarrubia
Role: primary
Related Links
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web page
Other Identifiers
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RESILIENCE-H2020
Identifier Type: -
Identifier Source: org_study_id
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