BridgeMD
New treatment option for Anthracycline-induced Cardiac Toxicity
Official title REmote iSchemic condItioning in Lymphoma PatIents REceiving ANthraCyclinEs
ClinicalTrials.gov ID: NCT05223413
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99
You may be able to join if
- ≥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...
You likely can't join if
- 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.
See the full eligibility 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Aarhus, Denmark
- Montivilliers, France
- Rouen, France
- Düsseldorf, Germany
- Amsterdam, Netherlands
- Lisbon, Portugal
- Alcalá de Henares, Spain
- Barcelona, Spain
- Granada, Spain
- Madrid, Spain
- Salamanca, Spain
- Seville, Spain
- Valladolid, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aarhus, Denmark; Montivilliers, France; Rouen, France; Düsseldorf, Germany; Amsterdam, Netherlands; Lisbon, Portugal and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.