Actively Recruiting
The Role of Compression Stockings in Patients with Heart Failure Comparing High vs. Low Compression Knee-High Stockings to Prevent Leg Swelling
Led by University of Maryland, Baltimore · Updated on 2024-10-02
50
Participants Needed
1
Research Sites
30 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
Researchers are evaluating the use of knee-high compression stockings in patients with congestive heart failure (CHF) who experience leg swelling due to fluid overload. The study aims to compare tight compression stockings (20-30 mmHg) with soft compression stockings (10-15 mmHg) to see if they help prevent swelling, skin changes, and venous disease without worsening heart failure symptoms. This is important because some patients with CHF have limited diuretic effectiveness and risk complications from chronic leg swelling. Participants will be randomly assigned to wear either high compression or low compression stockings for at least eight hours a day, five days a week, over a three-month period. Initial and final in-person visits will include blood tests, vein ultrasounds, medication reviews, physical exams, and health questionnaires. Between these visits, participants will have three virtual check-ins at one week, one month, and two months to monitor symptoms, medications, and weight. During the study, researchers will assess heart failure symptoms, kidney function, venous reflux, leg swelling severity, mobility, and quality of life. They will use questionnaires such as the Kansas City Cardiomyopathy Questionnaire and physical performance tests. Safety will be monitored by tracking adverse events and hospitalizations. The total participation time is three months, with evaluations at baseline, during follow-up, and at the end of the study.
CONDITIONS
Brief Title
The ROle of Compression StocKings in Heart Failure Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years and older
- Diagnosis of heart failure NYHA class II-III, stages A, B, or C
- Presence of pitting edema (swelling) in the lower legs
You will not qualify if you...
- Peripheral arterial disease with ankle-brachial index (ABI) of 0.5 or less
- Severe decompensated heart failure NYHA class IV
- Unstable acute coronary syndrome
- Severe valvular heart disease
- Hypertrophic obstructive cardiomyopathy
- Unstable arrhythmia without a defibrillator
- Receiving renal replacement therapy such as dialysis
- Morbid obesity with body mass index (BMI) over 40
- Pregnancy
- Lymphedema or lipoedema
- Unable to put on compression stockings by self or with help
- Acute inflammation or infection of the legs
- Life expectancy less than 6 months
- Unable to read or understand English
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants wear compression stockings daily to manage leg swelling and improve mobility. They are assigned to wear either high grade (20-30 mmHg) or low grade (10-15 mmHg) compression stockings for at least 8 hours a day, 5 days a week.
1 baseline visit (in-person), 1 telemedicine visit at 1 week, and 1 follow-up visit at 3 months (in-person)
Trial Site Locations
Total: 1 location
1
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
Research Team
R
Rafael S Cires-Drouet, MD
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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