protocolSection identificationModule nctId: NCT06350695, orgStudyIdInfo id: HP-00103478, secondaryIdInfos 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, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-17, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2026-01-01, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: University of Maryland, Baltimore, class: OTHER, collaborators name: National Institute on Aging (NIA), descriptionModule 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., conditionsModule conditions: Heart Failure，Congestive, conditions: Leg Edema, conditions: Venous Insufficiency, conditions: Venous Ulcers, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a prospective randomized-control 1:1 single blind study, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: low grade compression stockings (10-15 mmHg), interventions name: high grade compression stockings (20-30 mmHg), outcomesModule primaryOutcomes measure: Incidence of adverse events., primaryOutcomes measure: Change in symptoms of heart failure., primaryOutcomes measure: Change in kidney function., secondaryOutcomes measure: Change in venous reflux., secondaryOutcomes measure: Change in C Class from the CEAP classification for venous insufficiency., secondaryOutcomes measure: Mobility of the patient, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Maryland, status: RECRUITING, city: Baltimore, state: Maryland, zip: 21201, country: United States, contacts name: Rydica Newton, Research Coordinator, role: CONTACT, phone: 410-706-3941, email: RNewton@som.umaryland.edu, contacts name: Kim Nordstrom, role: CONTACT, email: knordstrom@som.umaryland.edu, contacts name: Rafael S Cires-Drouet, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.29038, lon: -76.61219, hasResults: False