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Clinical Trials in Spain / NCT05223413
Recruiting Not applicable

REmote iSchemic condItioning in Lymphoma PatIents REceiving ANthraCyclinEs

NCT05223413 · tracked via the Priya Life Science Spain tracker
Phase
Not applicable
Started
2022-01-18
Last updated
2025-09-18

Condition(s) studied

Anthracycline-induced Cardiac ToxicityLymphoma

Investigational drug(s) / intervention(s)

RIPCSimulated RIPC (Sham)

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.

Study 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

Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (24)

FacilityCityRegionStatus
Aarhus University Aarhus Denmark Recruiting
Hospital Jaques Monod, El Havre Montivilliers France Not Yet Recruiting
Henri Becquerel Rouen France Recruiting
University Hospital Duesseldorf UDUS Düsseldorf Germany Recruiting
Amsterdam UMC Amsterdam Netherlands Not Yet Recruiting
Hospital da Luz Learning Health (GLSMED) Lisbon Portugal Recruiting
IPO Lisboa Lisbon Portugal Recruiting
Hospital Universitario Príncipe de Asturias Alcalá de Henares Spain Not Yet Recruiting
Centro Medico Teknon Barcelona Spain Recruiting
Instituto Catalán de Oncología Barcelona Spain Recruiting
Hospital Universitario Virgen de las Nieves Granada Spain Recruiting
Centro Nacional de Investigaciones Cardiovasculares (CNIC) Madrid Spain Recruiting
Fundacion Jimenez Diaz Madrid Spain Recruiting
Hospital General Universitario Gregorio Marañon Madrid Spain Recruiting
Hospital Infanta Leonor Madrid Spain Recruiting
Hospital Puerta de Hierro Madrid Spain Recruiting
Hospital Universitario 12 de Octubre Madrid Spain Recruiting
Hospital Universitario Clínico San Carlos Madrid Spain Recruiting
Hospital Universitario la Paz Madrid Spain Recruiting
Hospital Universitario Ramon y Cajal Madrid Spain Recruiting
Hospital Universitario Ruber Juan Bravo Madrid Spain Recruiting
Hospital Universitario de Salamanca Salamanca Spain Recruiting
Hospital Universitario Virgen del Rocío Seville Spain Recruiting
Hospital Clinico Universitario de Valladolid Valladolid Spain Recruiting

More Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III trials in Spain

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05223413 on ClinicalTrials.gov ↗ ← All trials in Spain