NL-OMON56231尚未招募2 期
REmote iSchemic condItioning in Lymphoma PatIents REceiving ANthraCyclinEs (RESILIENCE) - Resilience
Centro Nacional de Investigaciones Cardiovasculares Carlos III (CNIC)0 个研究点目标入组 70 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- >=18 years old
- •- First NHL diagnosis
- •- Scheduled to undergo >=5 chemotherapy cycles including anthracyclines
- •.Pre-chemo LVEF >40% on screening echocardiography.
- •- Presence of >=1 of the following risk factors for developing cardiotoxicity:
- •o Previous coronary artery disease without evidence of prior myocardial
- •infarction (any of the following):
- •* Previous coronary revascularisation (PCI or CABG)
- •* Medical history of previous significant non-revascularized coronary stenosis
- •o LVEF 41-54%
- •o Age >= 65 years old
- •o Previous diagnosis of arterial hypertension (with or without treatment)
- •o Chronic kidney disease (estimated glomerular filtration rate <
- •60ml/min/1.73m2)
- •o Current or former smoker.
- •o Obesity (BMI>=30 kg/m2)
- •o LVH on screening echocardiography (LV thickness >=12mm).
- •o High alcohol intake (>=21 alcoholic beverages per week)
- •- Sinus rhythm on screening ECG
排除标准
- •- History of any of the following diseases:
- •o Any cancer who received anthracyclines treatment before the index episode
- •o Previous clinical diagnosis of heart failure.
- •o Previous diagnosis of acute myocardial infarction.
- •o Permanent atrial fibrillation (AF).
- •o Severe valvular or sub-valvular heart disease, either as a previously
- •clinical diagnosis or as a finding on screening echocardiography.
- •o Severe peripheral arterial disease in the upper extremities or arteriovenous
- •(AV) shunt in the arm selected for RIC.
- •- Clinical diagnosis of diabetes, with or without treatment.
- •- Contraindication for contrast enhanced CMR
- •- Severe thrombocytopenia (platelet <50) on any blood test within the previous
- •- Patients participating in other randomized clinical trials.
- •- Impossibility to consent or undergo study follow-ups
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