REmote iSchemic condItioning in Lymphoma PatIents REceiving ANthraCyclinEs
Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
608 participants
Jan 18, 2022
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
Inclusion Criteria5
- ≥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 Criteria14
- 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.
Interventions
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.
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)
View Full Details on ClinicalTrials.gov
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NCT05223413