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

Trial Summary

What is the purpose of this trial?

Congestive heart failure (CHF) occurs when the heart is weak and not able to effectively pump blood to the body. One of the common manifestations of CHF is fluid overload and swelling of the legs. Diuretics or "water pills" are usually the treatment for fluid overload and leg swelling; however, in some patients' diuretics are no longer effective or the effectiveness is limited due to poor kidney function. The presence of chronic swelling of the legs could potentially damage the veins; additionally, it could lead to chronic skin changes in the legs and in the worst cases to a leg ulcer. Compression stockings are used in patients with venous diseases to reduce the swelling of the legs and improve mobility and quality of life. Although, there is a theoretical risk that compression stockings might push the fluid of the legs back to the heart and lungs worsening the CHF. 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 stockings with minimum compression) are effective in preventing swelling and skin changes and safe in patients with CHF. During the first visit (in-person) a routine medical test will be performed including blood tests, review of the medication doses, current weight, an ultrasound images of the veins, (venous reflux ultrasound), questions about health status and a brief physical exam. The participants will be randomly assigned to receive tight compression vs. soft compression socks. Participants will be asked to wear the socks at least 8 hours a day for 5 days a week. There will be a total of 3 virtual visit (by video or telephone); the first one after one week, then after one month and two months. During the virtual visit participants will be asked about symptoms, current medications and doses, and current weight. The participants are expected to return to the clinic after 3 months for a second in-person visit. During this visit the investigators will ask questions about participant's health, they will perform a brief physical exam of their legs, and check participants weight and medicines; also, a venous ultrasound of the legs, questions about health status will be performed. The duration of the study is 3 months.

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 data supports the effectiveness of compression stockings as a treatment for congestive heart failure?

Research shows that graduated compression stockings can improve venous function by increasing venous refilling time, which may help with conditions involving poor blood circulation. However, the effectiveness of these stockings can vary based on their pressure gradient, and incorrect gradients may lead to complications. ^{1 2 3 4 5}

Are compression stockings generally safe for use in humans?

Compression stockings are generally safe, but there have been reports of ischaemic complications (reduced blood flow) in some cases, especially if the stockings are too tight or if the leg size is not properly considered. It's important to ensure the correct fit and pressure to avoid these issues. ^{1 2 4 6 7}

How do compression stockings differ from other treatments for congestive heart failure?

Compression stockings are unique because they are a non-drug treatment that helps improve blood flow in the legs by applying pressure, which can reduce swelling and improve circulation, unlike standard drug treatments like ACE inhibitors that work by affecting blood vessels and heart function. ^{8 9 10 11 12}

Eligibility Criteria

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.

I am 18 years old or older.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

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]

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]

References

1. South Africa pubmed.ncbi.nlm.nih.gov

Should knee-length replace thigh-length graduated compression stockings in the prevention of deep-vein thrombosis? [2006]

2. England pubmed.ncbi.nlm.nih.gov

Graduated compression and its relation to venous refilling time. [2019]

3. England 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. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Ischaemic complications of graduated compression stockings in the treatment of deep venous thrombosis. [2019]

5. Netherlands 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. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Difficulty associated with donning medical compression stockings: results from a survey comparing two different compression stockings. [2016]

7. United States pubmed.ncbi.nlm.nih.gov

Variability in leg compression provided by gradient commercial stockings. [2019]

8. Norway pubmed.ncbi.nlm.nih.gov

[Treatment of heart failure. A questionnaire among Norwegian hospital physicians]. [2015]

9. United States pubmed.ncbi.nlm.nih.gov

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

10. United States pubmed.ncbi.nlm.nih.gov

Treatment of chronic congestive heart failure with captopril, an oral inhibitor of angiotensin-converting enzyme. [2013]

11. United States pubmed.ncbi.nlm.nih.gov

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

12. Israel 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. [2008]