NCT06350695 The ROle of Compression StocKings in Heart Failure Patients
| NCT ID | NCT06350695 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Maryland, Baltimore |
| Condition | Heart Failure，Congestive |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-01-17 |
| Primary Completion | 2025-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2024-01-17 with a primary completion date of 2025-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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 compression stockings on by him/ herself or a person to do it for the patient * Septic phlebitis, acute bacterial, viral or allergic inflammation of the legs * Expectancy of life less than 6 months * Unable to read or understand English language
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06350695 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Failure，Congestive. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06350695 currently recruiting?
Yes, NCT06350695 is actively recruiting participants. Contact the research team at rafael.cires-drouet@UTSouthwestern.edu for enrollment information.
Where is the NCT06350695 trial being conducted?
This trial is being conducted at Dallas, United States.
Who is sponsoring the NCT06350695 clinical trial?
NCT06350695 is sponsored by University of Maryland, Baltimore. The trial plans to enroll 50 participants.
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.