The ROle of Compression StocKings in Heart Failure Patients

NCT06350695 | Recruiting DMC FDA Device

• 2 other identifiers: HP-001034781R21AG080424-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Incidence of adverse events.

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

  3 months

• 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.

  3 months

• 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.

  3 months

Secondary Outcomes (3)

• Change in venous reflux.

  3 months

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

  3 months

• Mobility of the patient

  3 months

Study Arms (2)

low grade compression stocking arm

PLACEBO COMPARATOR

Patients will be assigned to receive 2 pairs of low grade compression stockings (10-15 mmHg), that they will be wearing at least 8 hours a day 5 days a week.

Device: low grade compression stockings (10-15 mmHg)

high grade compression stocking arm

EXPERIMENTAL

Patients will be assigned to receive 2 pairs of high grade compression stockings (20-30 mmHg), that they will be wearing at least 8 hours a day 5 days a week.

Device: high grade compression stockings (20-30 mmHg)

Interventions

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

low grade compression stocking arm

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

high grade compression stocking arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years and older
• Diagnosis of Heart failure NYHA II-III Class A, B, or C.
• Pitting edema of the lower extremities

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• National Institute on Aging (NIA): collaborator
• University of Texas Southwestern Medical Center: collaborator

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

MeSH Terms

Conditions

Heart Failure; Venous Insufficiency; Varicose Ulcer

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Varicose Veins; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Rafael S Cires-Drouet, MD

CONTACT

2146452174; rafael.cires-drouet@UTSouthwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective randomized-control 1:1 single blind study

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: April 5, 2024
• Study Start: January 17, 2024
• Primary Completion: June 1, 2025
• Study Completion: January 1, 2026
• Last Updated: October 2, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

US (1)