The ROle of Compression StocKings in Heart Failure Patients

压力袜对心力衰竭患者的作用

• 批准号: 10574068
• 负责人: Rafael S. Cires-Drouet
• 金额: $ 17.3万
• 依托单位: UNIVERSITY OF MARYLAND BALTIMORE
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-01 至 2025-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10574068
• 关键词: Accident and Emergency department; Adverse event; Affect; Bilateral; Body Weight; Brain natriuretic peptide; Cardiomyopathies; Catheters; Cellulitis; Cessation of life; Chronic; Cities; Classification; Clinical; Compression Stocking; Creatinine; Deterioration; Disease; Diuretics; Documentation; Edema; Enrollment; Femur; Fluid overload; Guidelines; Heart; Heart Atrium; Heart failure; Hospitalization; Intervention; Kansas; Knee; Leg; Lower Extremity; Medical; New York; Obstruction; Pain; Patients; Peripheral; Physical Performance; Physicians; Pilot Projects; Prevention; Preventive measure; Pulmonary artery structure; Quality of life; Questionnaires; Randomized; Recommendation; Reflux; Renal function; Risk; Role; SF-36; Safety; Saphenous Vein; Serum; Shortness of Breath; Signs and Symptoms; Structure of popliteal vein; Symptoms; Telemedicine; Testing; Time; United States; Varicose Ulcer; Venous; Venous Insufficiency; Visit; compression therapy; cost; dosage; human old age (65+); improved; improved mobility; innovation; millisecond; pressure; prevent; ultrasound; wound

Project Summary: Heart failure (HF) affects 6.2 million patients in the United States and was responsible of 13.4% of deaths in 2018 costing about 30.7 billion USD in 2012, and about 80% of all the patients with HF are >65 years old. Clinical manifestations include shortness of breath and peripheral edema. Diuretics are indicated to treat edema in patients with HF, however, its use is limited in patients with compromised kidney function. Peripheral edema is associated with pain, heavy legs, limited mobility, and poor quality of life, increasing the risk of cellulitis, and wounds. Heart failure was identified in up to 44% of patients with venous ulcers. The chronic use of compression stockings in HF patients has potential benefits such as a better control of the edema, decreasing the need for diuretics, improving mobility, prevention of progression of venous disease, and prevention of venous ulcers. To date, no major HF guidelines recommend in favor or against compression stockings in HF patients. The objective of this R21 proposal is to study the role of the compression stockings in preventing edema and venous disease in heart failure patients. Our hypothesis We hypothesize that the use of compression stockings will prevent developing or worsening venous disease (venous reflux, and venous ulcers), improving the edema of the lower extremities, mobility, and quality of life in HF patients without increasing the risk of HF deterioration, hospitalization, or death In Aim 1 we are planning to randomize patients to high degree (20-30 mmHg) vs. low degree (10-15 mmHg) compression stockings for 3 months and evaluate for clinical sign and symptoms of deterioration of heart failure, as well as need to change in diuretic therapy at the end of the therapy. In Aim 2a we are planning to evaluate if high degree compression stockings are associated with a difference in time of valve closure (venous reflux) by venous duplex ultrasound at 3 months. In Aim 2b we are planning to evaluate if high degree compression stockings are associated with a difference in clinical signs of venous disease at 3 months. In Aim 3 we are planning to evaluate if high degree compression stockings are associated with improvement in mobility and quality of life at 3 months. The contribution with this project is significant as edema and venous disease are very morbid condition in patients with heart failure, and a simple and preventive measure such as compression stockings, could be safe and easily implemented. Our project is innovative as we are planning to use compression stockings in patients with heart failure, something that physicians are reluctant to use due to possible decompensation and fluid overload. On the other hand, we consider that it could be easily implemented and prevent advanced venous disease.

项目概要： 心力衰竭（HF）影响美国620万患者，占美国死亡人数的13.4%。 2018年的费用约为2012年的307亿美元，约80%的心力衰竭患者年龄超过65岁。临床 临床表现包括呼吸急促和周围水肿。利尿剂适用于治疗 然而，对于HF患者，其使用仅限于肾功能受损的患者。外周水肿是 与疼痛、腿部沉重、活动受限和生活质量差相关，增加了蜂窝织炎的风险，以及 伤口高达44%的静脉性溃疡患者出现心力衰竭。长期使用压迫 在HF患者中穿长统袜具有潜在的益处，例如更好地控制水肿，减少 利尿剂、改善活动性、预防静脉疾病进展和预防静脉溃疡。到 迄今为止，没有主要的HF指南推荐支持或反对HF患者使用加压袜。 这项R21提案的目的是研究弹力袜在预防水肿和 心力衰竭患者的静脉疾病。 我们的假设我们假设使用弹力袜将防止发展或恶化 静脉疾病（静脉回流和静脉溃疡），改善下肢水肿，活动能力， HF患者的生活质量，而不增加HF恶化、住院或死亡的风险 在目标1中，我们计划将患者随机分为高度（20-30 mmHg）和低度（10-15 mmHg） 压缩袜3个月，并评估心力衰竭恶化的临床体征和症状， 以及在治疗结束时需要改变利尿剂治疗。 在目标2a中，我们计划评估高度压缩袜是否与以下差异相关： 3个月时通过静脉双功超声确定的瓣膜关闭时间（静脉返流）。 在目标2b中，我们计划评估高度压缩袜是否与以下差异相关： 3个月时静脉疾病的临床体征。 在目标3中，我们计划评估高度压缩袜是否与改善 3个月时的活动性和生活质量。 该项目的贡献是显着的水肿和静脉疾病是非常病态的病人 心脏衰竭，和一个简单的预防措施，如压缩袜，可能是安全和容易 切实贯彻 我们的项目是创新的，因为我们计划在心力衰竭患者中使用压缩袜， 由于可能的失代偿和体液过多，医生不愿意使用。另 一方面，我们认为它可以很容易地实施和预防晚期静脉疾病。