RecruitingNot ApplicableNCT06350695

The ROle of Compression StocKings in Heart Failure Patients


Sponsor

University of Maryland, Baltimore

Enrollment

50 participants

Start Date

Jan 17, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study looks at whether wearing compression stockings helps reduce leg swelling and improve symptoms in patients with heart failure who have fluid build-up in their lower legs. **You may be eligible if...** - You are 18 or older - You have been diagnosed with heart failure (NYHA class II or III) - You have visible pitting edema (swelling that leaves an indent when pressed) in your lower legs **You may NOT be eligible if...** - You have peripheral artery disease (poor blood flow to the legs) - You are in severe, decompensated heart failure (NYHA class IV) - You have an unstable heart condition (such as unstable angina or serious arrhythmia) - You are on dialysis or kidney replacement therapy - You have a BMI over 40 - You are pregnant - You have lymphedema or certain leg conditions (such as active leg infection or blood clots) - You are unable to put on compression stockings yourself or with help Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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


Locations(1)

University of Texas Southwestern Medical Center

Dallas, Texas, United States

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NCT06350695


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