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Simple cuff trick may shield hearts from chemo damage

NCT ID NCT05223413

Disease control Sponsor: Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests whether temporarily stopping blood flow in the arm with a blood pressure cuff can protect the hearts of lymphoma patients receiving chemotherapy. The procedure, called remote ischemic preconditioning, is done before each chemo session. Researchers will compare heart function in 608 patients who receive either the real procedure or a sham version to see if it reduces heart damage.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Remote Ischemic PreConditioning (RIPC) using a modified blood pressure cuff
What this could lead to
If it works, this could offer a simple, low-cost way to protect the heart during chemotherapy, reducing the risk of long-term heart damage.
What could go wrong
This is a proof-of-concept phase II trial, so results are still early. The procedure may not provide significant heart protection, and individual responses could vary.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 608 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2022

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

breast cancer lymphoma cardiomyopathy due to anthracyclines prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anthracycline-induced cardiac toxicity Lymphoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    24 sites in 6 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Aarhus University

    RECRUITING

    Aarhus, Denmark

  • Amsterdam UMC

    NOT_YET_RECRUITING

    Amsterdam, Netherlands

  • Centro Medico Teknon

    RECRUITING

    Barcelona, Spain

  • Centro Nacional de Investigaciones Cardiovasculares (CNIC)

    RECRUITING

    Madrid, Spain

  • Fundacion Jimenez Diaz

    RECRUITING

    Madrid, Spain

  • Henri Becquerel

    RECRUITING

    Rouen, France

  • Hospital Clinico Universitario de Valladolid

    RECRUITING

    Valladolid, Spain

  • Hospital General Universitario Gregorio Marañon

    RECRUITING

    Madrid, Spain

  • Hospital Infanta Leonor

    RECRUITING

    Madrid, Spain

  • Hospital Jaques Monod, El Havre

    NOT_YET_RECRUITING

    Montivilliers, France

  • Hospital Puerta de Hierro

    RECRUITING

    Madrid, Spain

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, Spain

  • Hospital Universitario Clínico San Carlos

    RECRUITING

    Madrid, Spain

  • Hospital Universitario Príncipe de Asturias

    NOT_YET_RECRUITING

    Alcalá de Henares, Spain

  • Hospital Universitario Ramon y Cajal

    RECRUITING

    Madrid, Spain

  • Hospital Universitario Ruber Juan Bravo

    RECRUITING

    Madrid, Spain

  • Hospital Universitario Virgen de las Nieves

    RECRUITING

    Granada, Spain

  • Hospital Universitario Virgen del Rocío

    RECRUITING

    Seville, Spain

  • Hospital Universitario de Salamanca

    RECRUITING

    Salamanca, Spain

  • Hospital Universitario la Paz

    RECRUITING

    Madrid, Spain

  • Hospital da Luz Learning Health (GLSMED)

    RECRUITING

    Lisbon, Portugal

  • IPO Lisboa

    RECRUITING

    Lisbon, Portugal

  • Instituto Catalán de Oncología

    RECRUITING

    Barcelona, Spain

  • University Hospital Duesseldorf UDUS

    RECRUITING

    Düsseldorf, Germany

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