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Status:

RECRUITING

REmote iSchemic condItioning in Lymphoma PatIents REceiving ANthraCyclinEs

Lead Sponsor:

Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III

Collaborating Sponsors:

European Commission

Conditions:

Anthracycline-induced Cardiac Toxicity

Lymphoma

Eligibility:

All Genders

18-99 years

Phase:

NA

Brief 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) i...

Detailed Description

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) i...

Eligibility Criteria

Inclusion

  • ≥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

  • 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.

Key Trial Info

Start Date :

January 18 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2026

Estimated Enrollment :

608 Patients enrolled

Trial Details

Trial ID

NCT05223413

Start Date

January 18 2022

End Date

December 1 2026

Last Update

September 18 2025

Active Locations (24)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 6 (24 locations)

1

Aarhus University

Aarhus, Denmark

2

Hospital Jaques Monod, El Havre

Montivilliers, France

3

Henri Becquerel

Rouen, France

4

University Hospital Duesseldorf UDUS

Düsseldorf, Germany