The ROle of Compression StocKings in Heart Failure Patients
University of Maryland, Baltimore
Summary
Congestive heart failure (CHF) occurs when the heart is weak and not able to effectively pump blood to the body. One of the common manifestations of CHF is fluid overload and swelling of the legs. Diuretics or "water pills" are usually the treatment for fluid overload and leg swelling; however, in some patients' diuretics are no longer effective or the effectiveness is limited due to poor kidney function. The presence of chronic swelling of the legs could potentially damage the veins; additionally, it could lead to chronic skin changes in the legs and in the worst cases to a leg ulcer. Compression stockings are used in patients with venous diseases to reduce the swelling of the legs and improve mobility and quality of life. Although, there is a theoretical risk that compression stockings might push the fluid of the legs back to the heart and lungs worsening the CHF. The purpose of this study is to determine whether the use of knee-high tight socks (tight stockings with strong compression) vs. knee-high soft socks (soft stockings with minimum compression) are effective in preventing swelling and skin changes and safe in patients with CHF. During the first visit (in-person) a routine medical test will be performed including blood tests, review of the medication doses, current weight, an ultrasound images of the veins, (venous reflux ultrasound), questions about health status and a brief physical exam. The participants will be randomly assigned to receive tight compression vs. soft compression socks. Participants will be asked to wear the socks at least 8 hours a day for 5 days a week. There will be a total of 3 virtual visit (by video or telephone); the first one after one week, then after one month and two months. During the virtual visit participants will be asked about symptoms, current medications and doses, and current weight. The participants are expected to return to the clinic after 3 months for a second in-person visit. During this visit the investigators will ask questions about participant's health, they will perform a brief physical exam of their legs, and check participants weight and medicines; also, a venous ultrasound of the legs, questions about health status will be performed. The duration of the study is 3 months.
Description
Introduction 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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age 18 years and older * Diagnosis of Heart failure NYHA II-III Class A, B, or C. * Pitting edema of the lower extremities Exclusion Criteria: * Peripheral arterial disease with ABI of 0.5 or less * Severe decompensated heart failure NYHA IV * Unstable acute coronary syndrome * Severe valvular stenosis or regurgitation * Hypertrophic obstructive cardiomyopathy * Unstable arrhythmia without a defibrillator * On renal replacement therapy, hemodialysis of peritoneal dialysis * Morbid obesity with a BMI \> 40 * Pregnancy * Lymphedema or Lipoedema * Unable to put the com…
Interventions
- Devicelow grade compression stockings (10-15 mmHg)
Patient will wear low grade compression stockings (10-15 mmHg) at least 8 hours a day 5 days a week
- Devicehigh grade compression stockings (20-30 mmHg)
Patient will wear low grade compression stockings (20-30 mmHg) at least 8 hours a day 5 days a week
Location
- University of Texas Southwestern Medical CenterDallas, Texas