Compression Stockings for Congestive Heart Failure (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

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in kidney function.

Change in symptoms of heart failure.

Incidence of adverse events.

Secondary study objectives

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

Change in venous reflux.

Mobility of the patient

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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