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Compression Stockings
high grade compression stocking arm for Venous Insufficiency (ROCK-HF Trial)
N/A
Recruiting
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
ROCK-HF Trial Summary
"This trial is looking at whether tight compression socks or soft compression socks are more effective in preventing swelling and skin changes in patients with congestive heart failure. Participants will be randomly assigned to wear either type of
Who is the study for?
This trial is for heart failure patients experiencing leg swelling and potential skin changes due to fluid buildup. Participants must be able to wear compression stockings daily and attend both in-person and virtual check-ups. Those with poor kidney function affecting diuretic use may also join.Check my eligibility
What is being tested?
The study tests if knee-high tight socks (high-grade compression) versus soft socks (low-grade compression) can prevent leg swelling without worsening heart failure symptoms. It involves routine medical tests, wearing the assigned stockings, and follow-up visits over three months.See study design
What are the potential side effects?
Potential side effects include discomfort or skin irritation from the stockings. There's a small risk that increased pressure on the legs could push fluids back towards the heart, possibly exacerbating heart failure symptoms.
ROCK-HF Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in kidney function.
Change in symptoms of heart failure.
Incidence of adverse events.
Secondary outcome measures
Change in C Class from the CEAP classification for venous insufficiency.
Change in venous reflux.
Mobility of the patient
ROCK-HF Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: high grade compression stocking armExperimental Treatment1 Intervention
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.
Group II: low grade compression stocking armPlacebo Group1 Intervention
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.
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Who is running the clinical trial?
National Institute on Aging (NIA)NIH
1,675 Previous Clinical Trials
28,020,835 Total Patients Enrolled
University of Maryland, BaltimoreLead Sponsor
688 Previous Clinical Trials
374,606 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are potential participants currently being actively enrolled in this medical study?
"Information from clinicaltrials.gov confirms that this investigation is presently enrolling volunteers. The trial was initially listed on January 17th, 2024, and last revised on April 1st, 2024."
Answered by AI
What is the total number of participants being recruited for this research investigation?
"Indeed, the current details on clinicaltrials.gov indicate that patient recruitment is ongoing for this trial. The trial was originally listed on January 17th, 2024 and last revised on April 1st, 2024. It aims to enroll a total of 50 participants from one designated site."
Answered by AI
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