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Anthracycline-induced Cardiac ToxicityRESILIENCENCT05223413

REmote iSchemic condItioning in Lymphoma PatIents REceiving ANthraCyclinEs

A study testing RIPC in people with Anthracycline-induced Cardiac Toxicity and Lymphoma, run by Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III at 24 sites in 6 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 99 years
What is being tested?
RIPC
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
608 participants
Where
24 sitesin 6 countries
Study dates
18 Jan 2022to Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥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)

Who cannot join

  • 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.
Show all 14Show fewer
  • 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.

Trial locations and contacts

24 sites in 6 countries. Contact the study team or a site near you to ask about taking part.

Borja Ibañez, MD PhD FESC contact

914501200 ext. 4302

bibanez@cnic.es

Noemi Escalera contact

914501200 ext. 5401

nescalera@cnic.es

24 sites in 6 countries

Spain17 sites, 17 recruiting

  • Hospital Universitario Príncipe de Asturias

    Alcalá de Henares

    Julio García Suarez

    Not yet recruiting

  • Centro Medico Teknon

    Barcelona

    Antonio Berruezo

    Recruiting

  • Instituto Catalán de Oncología

    Barcelona

    Eva Gonzalez

    Recruiting

  • Hospital Universitario Virgen de las Nieves

    Granada

    Jose Manuel Puerta

    Recruiting

  • Centro Nacional de Investigaciones Cardiovasculares (CNIC)

    Madrid

    Borja Ibañez

    Recruiting

  • Fundacion Jimenez Diaz

    Madrid

    Raul Córdoba

    Recruiting

  • Hospital General Universitario Gregorio Marañon

    Madrid

    Mariana Bastos

    Recruiting

  • Hospital Infanta Leonor

    Madrid

    Jose Angel Hernandez Rivas

    Recruiting

  • Hospital Puerta de Hierro

    Madrid

    Belen Navarro

    Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid

    Ana Jimenez

    Recruiting

  • Hospital Universitario Clínico San Carlos

    Madrid

    Celina Benavente

    Recruiting

  • Hospital Universitario la Paz

    Madrid

    Miguel Canales

    Recruiting

  • Hospital Universitario Ramon y Cajal

    Madrid

    Javier Lopez

    Recruiting

  • Hospital Universitario Ruber Juan Bravo

    Madrid

    Aranzazu Alonso Alonso

    Recruiting

  • Hospital Universitario de Salamanca

    Salamanca

    Alejandro Martin

    Recruiting

  • Hospital Universitario Virgen del Rocío

    Seville

    Guillermo Rodriguez

    Recruiting

  • Hospital Clinico Universitario de Valladolid

    Valladolid

    Maria Jesús Peñarrubia

    Recruiting

Other trials in Spain

France2 sites, 2 recruiting

  • Hospital Jaques Monod, El Havre

    Montivilliers

    Pierre Lebreton

    Not yet recruiting

  • Henri Becquerel

    Rouen

    Vincent Camus

    Recruiting

Other trials in France

Portugal2 sites, 2 recruiting

  • Hospital da Luz Learning Health (GLSMED)

    Lisbon

    Antonio Ferreira

    Recruiting

  • IPO Lisboa

    Lisbon

    Maria Gomes

    Recruiting

Other trials in Portugal

Denmark1 site, 1 recruiting

  • Aarhus University

    Aarhus

    Francesco Damore

    Recruiting

Other trials in Denmark

Germany1 site, 1 recruiting

  • University Hospital Duesseldorf UDUS

    Düsseldorf

    Florian Boenner

    Malte Kelm

    Recruiting

Other trials in Germany

Netherlands1 site, 1 recruiting

  • Amsterdam UMC

    Amsterdam

    Marie Jose Kersten

    Not yet recruiting

Other trials in Netherlands

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.

Read the detailed description

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. Patients scheduled to undergo ≥5 chemotherapy cycles will be eligible. Patients fulfilling all inclusion and no exclusion criteria will be enrolled and undergo baseline Cardiac Magnetic Baseline (CMR), and high sensitivity troponin (hsTn) and NT-proBNP blood test. Patients with confirmed LVEF >40% by CMR will be randomized 1:1 to RIPC vs simulated RIPC (Sham). After the third chemotherapy cycle, a second CMR+ hsTn/ NT-proBNP will be performed for the validation of the early marker of cardiotoxicity. A third hsTn/ NT-proBNP blood test will be performed in the last chemotherapy cycle. Nine weeks after finishing chemotherapy, a last CMR+ hsTn/ NT-proBNP will be performed. Patients will be followed-up for clinical events at 6, 12, 18, 30 and 42 months until the last patient undergoes the final CMR. When the last patient undergoes the third CMR, the follow-up will be closed. The median follow-up estimation for clinical endpoints is 36 months (range: 6 to 60 months).

Being tested
RIPC, Simulated RIPC (Sham)
Medical subject headings
Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RIPCDevice

    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)Device

    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.

Study groups in NCT05223413
Study groupRoleWhat they receive
Remote Ischemic ConditioningActive 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
Receives: Device: RIPC
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.
Receives: Device: Simulated RIPC (Sham)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 9 weeks after the last chemotherapy cycle (anticipated to be between 150 and 200 days from enrollment)

Secondary outcomes (6)

  1. Primary efficacy endpoint: (RIC vs Sham) Absolute change in LVEF

    change in LVEF between baseline and any follow-up CMRs, whichever shows worse LVEF

    UNITS: LVEF is expressed as % LVEF= (LV end-diastolic volume - LV end-systolic volume) / LV end-systolic volume), %

    Measured: 9 weeks after the last chemotherapy cycle (anticipated to be between 150 and 200 days from enrollment)

  2. Rate of tumor regression.

    Response to chemotherapy

    UNITS: absolute number of patients in each arm qualifying as responder or no responder (i.e. each patient will be qualified at the end of the study as YES/NO).

    Measured: 9 weeks after the last chemotherapy cycle (anticipated to be between 150 and 200 days from enrollment)

  3. Change in Quality of Life-Haematological Malignancy Patient-Reported Outcome Measure questionnaire

    Haematological Malignancy Patient-Reported Outcome Measure (HM-PRO) questionnaire

    UNITS: absolute points in the questionnaire. minimum value 0 maximum value 84

    the higher the total score, the better (greater the effect on a patient's QoL)

    Measured: 9 weeks after the last chemotherapy cycle (anticipated to be between 150 and 200 days from enrollment)

  4. Change in Quality of Life-Euro Quality of Life-5 dimensions questionnaire

    Euro Quality of Life-5 dimensions (EuroQoL-5D) questionnaire:

    UNITS: absolute points in the questionnaire. minimum value 0 maximum value 100

    the higher the total score, the better (greater the effect on a patient's QoL)

    Measured: 9 weeks after the last chemotherapy cycle (anticipated to be between 150 and 200 days from enrollment)

  5. Change in Quality of Life-Kansas City Cardiomyopathy Questionnaire

    Kansas City Cardiomyopathy Questionnaire (KCCQ-12)

    UNITS: absolute points in the questionnaire. minimum value 0 maximum value 65

    the higher the total score, the better (greater the effect on a patient's QoL)

    Measured: 9 weeks after the last chemotherapy cycle (anticipated to be between 150 and 200 days from enrollment)

  6. Rate of Heart Failure Hospitalization

    Rate of Heart Failure Hospitalization

    UNITS: Absolute number of patients in each arm experiencing a heart failure hospitalization

    Measured: 4-60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2022
  2. Study start18 Jan 2022
  3. Primary completionJun 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomization (1:1) will be stratified by LVEF on baseline CMR (as quantified by CMR core lab /CNIC), by research Centre and by patient's gender.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
608 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05223413
Sponsor's protocol ID
RESILIENCE-H2020
Acronym
RESILIENCE
Status last verified
Oct 2026
First submitted
20 Dec 2021
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing RIPC in people with Anthracycline-induced Cardiac Toxicity and Lymphoma, run by Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III at 24 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in Spain, France, Portugal, Denmark, Germany and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Borja Ibañez, MD PhD FESC (914501200 ext. 4302, bibanez@cnic.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of anthracycline-induced cardiotoxicity events (time frame: 9 weeks after the last chemotherapy cycle (anticipated to be between 150 and 200 days from enrollment)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05223413.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.

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