nctId: NCT06350695 id: HP-00103478 id: 1R21AG080424-01 type: NIH link: https://reporter.nih.gov/quickSearch/1R21AG080424-01 briefTitle: The ROle of Compression StocKings in Heart Failure Patients acronym: ROCK-HF overallStatus: RECRUITING date: 2024-01-17 date: 2025-06-01 date: 2026-01-01 date: 2024-04-05 date: 2024-04-05 name: University of Maryland, Baltimore class: OTHER name: National Institute on Aging (NIA) briefSummary: 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. conditions: Heart Failure，Congestive conditions: Leg Edema conditions: Venous Insufficiency conditions: Venous Ulcers studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a prospective randomized-control 1:1 single blind study primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 50 type: ESTIMATED name: low grade compression stockings (10-15 mmHg) name: high grade compression stockings (20-30 mmHg) measure: Incidence of adverse events. measure: Change in symptoms of heart failure. measure: Change in kidney function. measure: Change in venous reflux. measure: Change in C Class from the CEAP classification for venous insufficiency. measure: Mobility of the patient sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Maryland status: RECRUITING city: Baltimore state: Maryland zip: 21201 country: United States name: Rydica Newton, Research Coordinator role: CONTACT phone: 410-706-3941 email: RNewton@som.umaryland.edu name: Kim Nordstrom role: CONTACT email: knordstrom@som.umaryland.edu name: Rafael S Cires-Drouet, MD role: PRINCIPAL_INVESTIGATOR lat: 39.29038 lon: -76.61219 hasResults: False