Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06350695

The ROle of Compression StocKings in Heart Failure Patients

Led by University of Maryland, Baltimore · Updated on 2024-10-02

50

Participants Needed

1

Research Sites

102 weeks

Total Duration

On this page

Sponsors

U

University of Maryland, Baltimore

Lead Sponsor

N

National Institute on Aging (NIA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

The ROle of Compression StocKings in Heart Failure Patients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years and older
  • Diagnosis of Heart failure NYHA II-III Class A, B, or C
  • Pitting edema of the lower extremities
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Texas Southwestern Medical Center

Dallas, Texas, United States, 75390

Actively Recruiting

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Research Team

R

Rafael S Cires-Drouet, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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