Using compression stockings to help heart failure patients
The ROle of Compression StocKings in Heart Failure Patients
NA · University of Maryland, Baltimore · NCT06350695
This study tests if wearing compression stockings can help people with heart failure and leg swelling feel better and move easier.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Maryland, Baltimore (other) |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT06350695 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of compression stockings on patients with congestive heart failure (CHF) who experience leg swelling. It aims to determine whether these stockings can reduce edema, improve mobility, and enhance quality of life without worsening heart failure symptoms. The study will involve patients aged 18 and older with specific heart failure classifications and pitting edema in the lower extremities. Participants will be treated with either low-grade or high-grade compression stockings to assess their effectiveness.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with NYHA Class II-III heart failure and experiencing pitting edema in their lower extremities.
Not a fit: Patients with severe decompensated heart failure, unstable coronary conditions, or those unable to use compression stockings independently may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive treatment option to improve the quality of life for heart failure patients suffering from leg swelling.
How similar studies have performed: Previous studies have shown that compression therapy in heart failure patients does not lead to increased mortality or hospitalizations, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 years and older * Diagnosis of Heart failure NYHA II-III Class A, B, or C. * Pitting edema of the lower extremities Exclusion Criteria: * 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
Where this trial is running
Dallas, Texas
- University of Texas Southwestern Medical Center — Dallas, Texas, United States (RECRUITING)
Study contacts
- Study coordinator: Rafael S Cires-Drouet, MD
- Email: rafael.cires-drouet@UTSouthwestern.edu
- Phone: 2146452174
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Heart Failure，Congestive, Leg Edema, Venous Insufficiency, Venous Ulcers, compression stockings, congestive heart failure, venous insufficiency, edema of the legs