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 万名患者，导致 13.4% 的死亡 2018年的费用比2012年约307亿美元，所有心力衰竭患者中约80%年龄>65岁。临床 表现包括呼吸急促和外周水肿。利尿剂用于治疗水肿 然而，心力衰竭患者的使用仅限于肾功能受损的患者。周围水肿是 与疼痛、腿部沉重、活动受限和生活质量差相关，增加蜂窝织炎的风险，以及 伤口。高达 44% 的静脉性溃疡患者出现心力衰竭。长期使用压力 心力衰竭患者穿长袜具有潜在的好处，例如更好地控制水肿、减少对 利尿剂，改善活动能力，预防静脉疾病的进展，以及预防静脉溃疡。到 迄今为止，没有主要的心力衰竭指南建议赞成或反对心力衰竭患者使用压力袜。 该 R21 提案的目的是研究压力袜在预防水肿和预防水肿方面的作用。 心力衰竭患者的静脉疾病。 我们的假设 我们假设使用压力袜可以防止病情发展或恶化 静脉疾病（静脉反流、静脉性溃疡），改善下肢水肿、活动能力等 心力衰竭患者的生活质量不会增加心力衰竭恶化、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程度 (20-30 mmHg) 与低程度 (10-15 mmHg) 穿着压力袜 3 个月，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治疗。 在目标 2a 中，我们计划评估高度压力袜是否与以下差异相关： 3 个月时通过静脉双功能超声检查瓣膜关闭（静脉回流）的时间。 在目标 2b 中，我们计划评估高度压力袜是否与以下差异相关： 3个月时出现静脉疾病的临床症状。 在目标 3 中，我们计划评估高度压力袜是否与改善 3个月后的活动能力和生活质量。 该项目的贡献是显着的，因为水肿和静脉疾病是患者的非常病态的疾病 患有心力衰竭，采取简单的预防措施（例如压力袜）可能是安全且容易的 实施的。 我们的项目是创新的，因为我们计划对心力衰竭患者使用压力袜， 由于可能出现代偿失调和液体超负荷，医生不愿意使用这种药物。另一方面 另一方面，我们认为它可以很容易地实施并预防晚期静脉疾病。