RecruitingNot ApplicableNCT05223413

REmote iSchemic condItioning in Lymphoma PatIents REceiving ANthraCyclinEs


Sponsor

Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III

Enrollment

608 participants

Start Date

Jan 18, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether a technique called remote ischemic conditioning — briefly and repeatedly cutting off blood flow to an arm using a blood pressure cuff — can protect the heart from damage caused by anthracycline chemotherapy (a common type of chemo known to affect the heart). **You may be eligible if...** - You are 18 or older - You have been diagnosed with lymphoma (NHL, HL) or breast cancer - You are scheduled to receive at least 240 mg/m² total cumulative dose of anthracycline chemotherapy - Your heart function (ejection fraction) is above 40% at screening - You have at least one risk factor for developing heart damage from chemo (such as prior heart disease, high blood pressure, diabetes, or obesity) **You may NOT be eligible if...** - You have severe pre-existing heart disease that would prevent participation - You have conditions affecting your arms that would make the blood pressure cuff procedure unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICERIPC

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.

DEVICESimulated 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.


Locations(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

View Full Details on ClinicalTrials.gov

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NCT05223413


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