Compression Stockings for Heart Failure and Leg Swelling

This study is looking at how compression stockings might help people with heart failure (when your heart can't pump enough blood) who also have leg swelling. Diuretics, or "water pills," are often used for swelling, but they don't always work well, especially if kidney function is poor. Swelling can also damage veins and lead to skin problems or ulcers. This study will compare two types of compression stockings: low-grade (10-15 mmHg) and high-grade (20-30 mmHg). You would wear them at least 8 hours a day, 5 days a week. The study wants to see if these stockings can reduce side effects, improve heart failure symptoms, and affect kidney function over 3 months. To join, you need to be 18 or older, have a heart failure diagnosis (NYHA Class II-III A, B, or C), and have pitting edema (swelling that leaves a dent when pressed) in your legs.

Study design
This is an interventional study with 50 planned participants. It compares two different types of compression stockings.
What's involved
You would wear either low-grade or high-grade compression stockings for at least 8 hours a day, 5 days a week.
Compensation
Not stated in the trial record.
Follow-up
Your progress will be measured at 3 months.

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NCT06350695

The ROle of Compression StocKings in Heart Failure Patients

Recruiting
NAAges 18+InterventionalTreatment
University of Maryland, Baltimore
~50 participants
Updated 2024-10-02 on ClinicalTrials.gov
What's tested:low grade compression stockings (10-15 mmHg)high grade compression stockings (20-30 mmHg)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events.
Measured over 3 months
+2 more outcomes measured
Heart Failure,Congestive
Leg Edema
Venous Insufficiency
Venous Ulcers
1 sites across 1 states
Texas1

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Eligibility criteria

Inclusion

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

Exclusion

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
  • Incidence of adverse events.3 months

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

  • Change in symptoms of heart failure.3 months

    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.

  • Change in kidney function.3 months

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