Compression Stockings for Congestive Heart Failure

(ROCK-HF Trial)

Recruiting at 1 trial location

Overseen By Rafael S Cires-Drouet, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Maryland, Baltimore

Disqualifiers: Peripheral arterial disease, Severe heart failure, Unstable coronary syndrome, others

Compensation: Varies

Number of Visits: 1

Duration: 3 months

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether tight or soft compression socks can aid people with congestive heart failure (CHF) by reducing leg swelling and preventing skin changes. CHF often causes fluid buildup, leading to swollen legs, and sometimes water pills are ineffective due to kidney issues. The study aims to determine if these socks are effective and safe without worsening CHF. Participants should have CHF and noticeable leg swelling. They will wear either tight or soft socks for most of the week and attend both virtual and in-person check-ups over three months. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance CHF management.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, your medications and doses will be reviewed during the study, so it's best to discuss this with the trial team.

What prior data suggests that compression stockings are safe for patients with congestive heart failure?

Research has shown that compression stockings can reduce leg swelling in people with heart failure. One study found that these stockings can lower certain heart stress markers and improve symptoms in patients with stable heart failure, indicating that the treatment is generally well-tolerated.

A theoretical concern exists that compression stockings might push fluid back to the heart and lungs, potentially worsening heart failure. However, evidence still supports the safety of compression stockings, especially for those with stable heart failure.

In summary, compression stockings are generally considered safe for people with heart failure, but individual experiences may vary. It's important to discuss any new treatment with a healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using compression stockings for congestive heart failure because they offer a non-invasive way to potentially manage symptoms. Unlike typical treatments for heart failure, which often involve medications like diuretics or beta-blockers, compression stockings aim to improve circulation and reduce swelling through mechanical support. The trial is investigating both high-grade and low-grade compression stockings, which differ in the level of pressure they apply. This approach could provide a simple, side-effect-free option that enhances quality of life for patients by reducing fluid retention and improving blood flow.

What evidence suggests that compression stockings are effective for congestive heart failure?

This trial will compare high-grade compression stockings with low-grade compression stockings for managing leg swelling in congestive heart failure. Studies have shown that compression stockings can reduce leg swelling in heart failure patients. Research indicates that strong compression stockings safely lessen symptoms and improve blood flow. They achieve this by lowering high blood pressure in the veins and enhancing the drainage of excess fluid, which reduces leg swelling. Evidence suggests that compression stockings can also lower BNP levels, a marker linked to heart failure severity, indicating symptom improvement. These findings support the potential effectiveness of compression stockings in managing leg swelling in congestive heart failure. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My heart failure is moderate to moderately severe.

I have swelling in my legs that leaves a dent when pressed.

Exclusion Criteria

I have severe leg artery disease with very low blood flow.

I have a serious heart valve problem.

My BMI is over 40, indicating morbid obesity.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to receive either high compression or low compression stockings and are asked to wear them for at least 8 hours a day, 5 days a week.

3 months

1 in-person visit, 3 virtual visits

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of heart failure symptoms, kidney function, and venous reflux.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• High Grade Compression Stockings
• Low Grade Compression Stockings

Trial Overview 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.

How Is the Trial Designed?

Group I: high grade compression stocking arm Experimental Treatment 1 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 arm Placebo Group 1 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.

High Grade Compression Stockings is already approved in United States, European Union, Japan for the following indications:

Approved in United States as Compression Stockings for:

• Venous Insufficiency
• Edema
• Varicose Veins
• Venous Ulcers

Approved in European Union as Compression Stockings for:

• Venous Insufficiency
• Edema
• Varicose Veins
• Venous Ulcers

Approved in Japan as Compression Stockings for:

• Venous Insufficiency
• Edema
• Varicose Veins
• Venous Ulcers

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

University of Texas Southwestern Medical Center

Collaborator

Trials

1,102

Recruited

1,077,000+

Published Research Related to This Trial

A study tested 15 types of below-knee compression stockings on 13 healthy volunteers to evaluate their pressure profiles, finding that only five types met the necessary standards for effective venous function.

In patients with venous abnormalities, the three satisfactory stockings improved venous refilling times to normal levels, while the unsatisfactory stockings did not, highlighting the importance of selecting the right compression stockings for effective treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Graduated compression and its relation to venous refilling time. Cornwall, JV., Doré, CJ., Lewis, JD.[2019]

Graduated compression stockings, commonly used to prevent deep venous thrombosis and treat venous insufficiency, can lead to ischaemic complications, as illustrated by two patient cases.

The pressure from these stockings can significantly reduce local blood flow, especially as leg girth increases, suggesting that their routine prescription should be reconsidered due to the potential risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ischaemic complications of graduated compression stockings in the treatment of deep venous thrombosis. Merrett, ND., Hanel, KC.[2019]

In a study involving 220 women, those using progressive medical compression stockings (MCSs) reported significantly better comfort and ease of use compared to conventional degressive MCSs.

The findings suggest that progressive MCSs may improve patient compliance in wearing stockings for chronic venous disease treatment, which is crucial for effective management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Difficulty associated with donning medical compression stockings: results from a survey comparing two different compression stockings. Benigni, JP., Branchoux, S., Bacle, I., et al.[2016]

In a survey of 117 physicians treating congestive heart failure, diuretics and sodium/water restrictions were overwhelmingly chosen as the first-line therapy for mild heart failure, with ACE-inhibitors and digitalis being rarely selected.

For moderate and severe heart failure, while diuretics remained popular, 20% of physicians preferred ACE-inhibitors as a first-line option, indicating a shift in treatment priorities as the severity of heart failure increases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment of heart failure. A questionnaire among Norwegian hospital physicians]. Mangschau, A., Klemsdal, TO.[2015]

Enalapril, an ACE inhibitor, has been shown to improve various health metrics in patients with congestive heart failure (CHF), including functional class, cardiac index, and exercise tolerance.

Recent trial data indicate that enalapril treatment in severe CHF patients led to a reduction in heart size, decreased reliance on additional heart-failure medications, and lower mortality rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enalapril in the treatment of congestive heart failure. Giles, T.[2019]

In a study of 72 surgical patients, knee-length graduated compression stockings were found to be applied correctly by 70% of users, compared to only 35.7% for thigh-length stockings, indicating a significant difference in compliance (P = 0.009).

The results suggest that knee-length stockings are more effective for preventing deep-vein thrombosis in surgical patients due to higher rates of correct application, leading to a recommendation to replace thigh-length stockings with knee-length ones.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Should knee-length replace thigh-length graduated compression stockings in the prevention of deep-vein thrombosis? Hameed, MF., Browse, DJ., Immelman, EJ., et al.[2006]

In a study of 89 patients with hip or knee replacements, 98% of below-knee graded compression stockings failed to provide the ideal pressure gradient, which is crucial for preventing blood clots.

Stockings that produced a reversed pressure gradient were linked to a significantly higher incidence of deep vein thrombosis (25.6% vs. 6.1%), indicating that proper gradient performance is essential for safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Graded compression stockings in elective orthopaedic surgery. An assessment of the in vivo performance of commercially available stockings in patients having hip and knee arthroplasty. Best, AJ., Williams, S., Crozier, A., et al.[2019]

Graduated elastic compression stockings (GECS) significantly improved venous function (EF) more than inverse graduated compression stockings (PECS) in patients with chronic venous insufficiency, based on a study involving 64 participants (32 healthy volunteers and 32 CVI patients).

While both types of stockings enhanced venous drainage, PECS were easier to wear but tended to slip more, indicating a trade-off between comfort and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interface pressure and venous drainage of two compression stocking types in healthy volunteers and in patients with hemodynamic disturbances of the legs. Riebe, H., Konschake, W., Haase, H., et al.[2018]

Captopril, an oral angiotensin-converting enzyme inhibitor, significantly improved heart function in 10 patients with stable congestive heart failure, increasing cardiac index and reducing pulmonary-wedge pressure and systemic vascular resistance.

The hemodynamic benefits of captopril were observed within 90 minutes of administration and lasted for three to four hours, suggesting it may be a valuable treatment option for chronic congestive heart failure despite the exact mechanism of action not being fully understood.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of chronic congestive heart failure with captopril, an oral inhibitor of angiotensin-converting enzyme. Davis, R., Ribner, HS., Keung, E., et al.[2013]

Fosinopril, a new angiotensin-converting enzyme (ACE) inhibitor, is as effective as enalapril in treating congestive heart failure (CHF) and is particularly beneficial for patients with kidney issues due to its unique excretion pathways.

In addition to treating existing CHF symptoms, fosinopril may help prevent the progression of the disease by improving cardiac function, potentially delaying the onset of severe heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of congestive heart failure: experience with fosinopril. Blumenthal, M.[2019]

In a study of 362 hospitalized patients with congestive heart failure (CHF), only 70% were prescribed ACE inhibitors or angiotensin receptor blockers (ARBs) at discharge, with a significant drop in usage over the following year.

Common reasons for not prescribing these medications included hyperkalemia and elevated serum creatinine levels at discharge, while hypotension and cough became more common reasons for non-treatment during follow-up, highlighting the need for better management strategies to improve treatment rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of angiotensin-converting enzyme inhibitors and angiotensin receptor blockers in patients with congestive heart failure: an observational study of treatment rates and clinical outcome. Gotsman, I., Rubonivich, S., Azaz-Livshits, T.[2008]

A study of 36 different brands of class 2 compression stockings revealed significant variability in compression pressures, with most stockings providing adequate pressure at the ankle but falling short at the calf, which is crucial for effective venous flow.

Cheaper generic stockings performed similarly to more expensive brands in terms of compression and pressure gradients, suggesting that consumers can find effective options without spending a lot, but there is a need for better manufacturing standards and labeling to ensure accurate pressure information.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Variability in leg compression provided by gradient commercial stockings. Ma, H., Blebea, J., Malgor, RD., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06350695

The ROle of Compression StocKings in Heart Failure Patients The purpose of this study is to determine whether the use of knee-high tight socks (tight stockings with strong compression) vs. knee-high soft socks (soft ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7524111/

Compression therapy for leg oedema in patients with heart ... Lower limb compression in heart failure‐related oedema treatment: evidence‐based data on safety and efficacy. Despite the common use of ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4081237/

Graduated compression stockings - PMC Graduation compression can reverse venous hypertension, augment skeletal-muscle pump, facilitate venous return and improve lymphatic drainage.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2352906724000095

The safety and efficacy of compression therapy in patients ... This study demonstrates that compression therapy is associated with decreased BNP levels and symptom improvement in patients with stable, chronic heart failure.

5. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/477436

The ROle of Compression StocKings in Heart Failure Patients The purpose of this study is to determine whether the use of knee-high tight socks (tight stockings with strong compression) vs. knee-high soft ...