The ROle of Compression StocKings in Heart Failure Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Maryland, Baltimore

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Age 18 years and older

Diagnosis of Heart failure NYHA II-III Class A, B, or C.

Pitting edema of the lower extremities

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • low grade compression stockings (10-15 mmHg)

    Device

    Patient will wear low grade compression stockings (10-15 mmHg) at least 8 hours a day 5 days a week

  • high grade compression stockings (20-30 mmHg)

    Device

    Patient will wear low grade compression stockings (20-30 mmHg) at least 8 hours a day 5 days a week

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: low grade compression stocking armPlacebo comparator 1 intervention
Group B: high grade compression stocking armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of adverse events.

The number of adverse events (deaths and hospitalizations) will be recorded and compared between each group.

Time frame
3 months
2

Change in symptoms of heart failure.

This outcome measures the changes in the Kansas City Cardiomyopathy Questionnaire (KCCQ) scores from each group. KCCQ scores are from 0-100. The higher the score the better the patient is.

Time frame
3 months
3

Change in kidney function.

This outcome measures the change in BUN and creatinine from each group. BUN and creatinine will be measured in mg/dl.

Time frame
3 months

Secondary outcomes

1

Change in venous reflux.

This outcome measures the change in valve closure time (VCT) in milliseconds between the two groups.

Time frame
3 months
2

Change in C Class from the CEAP classification for venous insufficiency.

C class range from C0 to C6 and describe the clinical signs of venous insufficiency. This outcome will measure the difference of C class between both groups.

Time frame
3 months
3

Mobility of the patient

To measure mobility the Short Physical Performance Battery (SPPB) test is used. The test scores from 0-12. This outcome compares change in SPPB scores between both groups.

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Maryland, Baltimore

Lead sponsor

National Institute on Aging (NIA)

Collaborator

University of Texas Southwestern Medical Center

Collaborator