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)
Rate of anthracycline-induced cardiotoxicity events — 9 weeks after the last chemotherapy cycle (anticipated to be between 150 and 200 days from enrollment) 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).
Trial sites (24)
Facility
City
Region
Status
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
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.
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