RECRUITING

The ROle of Compression StocKings in Heart Failure Patients

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The ROle of Compression StocKings in Heart Failure Patients

Quick Facts

Study Start:2024-01-17
Study Completion:2026-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06350695

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18 years and older
  2. * Diagnosis of Heart failure NYHA II-III Class A, B, or C.
  3. * Pitting edema of the lower extremities
  1. * Peripheral arterial disease with ABI of 0.5 or less
  2. * Severe decompensated heart failure NYHA IV
  3. * Unstable acute coronary syndrome
  4. * Severe valvular stenosis or regurgitation
  5. * Hypertrophic obstructive cardiomyopathy
  6. * Unstable arrhythmia without a defibrillator
  7. * On renal replacement therapy, hemodialysis of peritoneal dialysis
  8. * Morbid obesity with a BMI \> 40
  9. * Pregnancy
  10. * Lymphedema or Lipoedema
  11. * Unable to put the compression stockings on by him/ herself or a person to do it for the patient
  12. * Septic phlebitis, acute bacterial, viral or allergic inflammation of the legs
  13. * Expectancy of life less than 6 months
  14. * Unable to read or understand English language

Contacts and Locations

Study Contact

Rafael S Cires-Drouet, MD
CONTACT
2146452174
rafael.cires-drouet@UTSouthwestern.edu

Study Locations (Sites)

University of Texas Southwestern Medical Center
Dallas, Texas, 75390
United States

Collaborators and Investigators

Sponsor: University of Maryland, Baltimore

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-17
Study Completion Date2026-01-01

Study Record Updates

Study Start Date2024-01-17
Study Completion Date2026-01-01

Terms related to this study

Keywords Provided by Researchers

  • compression stockings
  • congestive heart failure
  • venous insufficiency
  • edema of the legs
  • venous ulcers

Additional Relevant MeSH Terms

  • Heart Failure,Congestive
  • Leg Edema
  • Venous Insufficiency
  • Venous Ulcers