Compression Stockings for Congestive Heart Failure
(ROCK-HF Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Maryland, Baltimore
Disqualifiers: Peripheral arterial disease, Severe heart failure, Unstable coronary syndrome, others
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.
12345Are 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.
12467How 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.
89101112Eligibility 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.
+11 more
Trial 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
Participant Groups
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.
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.
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of MarylandBaltimore, MD
University of Texas Southwestern Medical CenterDallas, TX
Loading ...
Who Is Running the Clinical Trial?
University of Maryland, BaltimoreLead Sponsor
National Institute on Aging (NIA)Collaborator
University of Texas Southwestern Medical CenterCollaborator
References
Should knee-length replace thigh-length graduated compression stockings in the prevention of deep-vein thrombosis? [2006]To compare knee-length with thigh-length graduated compression stockings for correct application and rate of compliance when they are prescribed for the prevention of deep-vein thrombosis in surgical patients.
Graduated compression and its relation to venous refilling time. [2019]Graduated compression is important in improving venous function, but the pressure profiles of different brands of stockings in situ and effects on a direct measure of venous function have not been investigated. The pressure profiles of 15 different types of below knee compression stockings were established with a medical stocking tester in 13 healthy volunteers. Analysis of variance was performed for each stocking separately, considering the factors of size of stocking, site of measurement, and their interaction. The criteria used to define satisfactory function were that the stockings should have a significant linear trend with site--that is, graduation--and no other significant effects. Only five types of stockings met these standards. Venous function was then assessed by photoplethysmography in 19 patients with defined venous abnormalities. For each patient the effect on venous refilling time of three satisfactory and three unsatisfactory stockings was assessed. The three satisfactory stockings gave refilling times that were not significantly different from normal in patients with both superficial and deep vein incompetence, while refilling times with the three unsatisfactory stockings remained significantly below normal in all patients with deep vein incompetence; one stocking had no significant effect on refilling times in either group. Functional testing of compression hosiery should form part of future British Standards specifications.
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]We recruited 89 patients who had hip or knee replacements to assess the performance of below-knee graded compression stockings. The pressure gradients generated by the stockings were measured and all patients had venography of the ipsilateral leg. We found that 98% of stockings failed to produce the 'ideal' pressure gradient (+/- 20%) of 18, 14 and 8 mmHg from the ankle to the knee, while 54% produced a 'reversed gradient' on at least one occasion during the course of the study. The overall rate of deep-venous thrombosis was 16.7%. Stockings which produced reversed gradients were associated with a significantly higher incidence of deep-venous thrombosis (p = 0.026) than those with the correct gradient (25.6% v 6.1%). This suggests that the performance of graded compression stockings can be improved if reversed pressure gradients are detected and prevented.
Ischaemic complications of graduated compression stockings in the treatment of deep venous thrombosis. [2019]Graduated compression stockings are frequently used in the prevention of deep venous thrombosis and the treatment of venous insufficiency. Two patients are discussed who sustained ischaemic complications after application of graduated compression stockings. Review of the literature demonstrates that low cutaneous pressures significantly decrease local blood flow and that the amount of pressure exerted by graduated compression stockings increases significantly with increases in leg girth. Ischaemic complications associated with the use of these stockings also appears to be more common than previously thought and any policy of routine prescription to patients should be questioned.
Interface pressure and venous drainage of two compression stocking types in healthy volunteers and in patients with hemodynamic disturbances of the legs. [2018]Standard of care in the therapy of chronic venous insufficiency (CVI) is the use of graduated elastic stockings (GECS). This paper is based on a prospective, mono-centric, open randomised, controlled and cross over study and discusses the hemodynamic effects of GECS and inverse graduated compression stockings (PECS) in 32 healthy volunteers and 32 patients with CVI and the consecutive impact on comfort. The application of stockings was performed sequentially, the allocation of the first stocking was randomized and double blind, wearing period for each stocking type about 7 days with one week of break between wearing periods. Measurements of the interface pressure were carried out by Picopress®(Microlab Elettronica, Italy) and the venous drainage were registered by strain gauge plethysmography. Mean interface pressure: GECS (level B1): 27.3 mmHg; GECS (level C): 19,6 mmHg; PECS (level B1): 17,8 mmHg; PECS (level C): 24,7 mmHg. Significant increase of EF and decrease of VFI by wearing both types of compression stockings, comparatively GESC resulted in a significantly greater improvement of EF than the PECS. PECS were significantly easier to don and put on compared to the GECS, the PECS tended to slip towards the foot more often.
Difficulty associated with donning medical compression stockings: results from a survey comparing two different compression stockings. [2016]Although medical compression stockings (MCSs) represent the cornerstone of conservative treatment for patients with chronic venous disease, high rates of noncompliance exist. This study compared comfort levels and the difficulty associated with putting on/removing two different MCSs; a conventional degressive MCS (ankle pressure: 24-28 mmHg; calf pressure: 14-18 mmHg) and a progressive MCS (ankle pressure: 8-12 mmHg; calf pressure: 21-25 mmHg).
Variability in leg compression provided by gradient commercial stockings. [2019]Compression stockings are commonly prescribed by physicians for lower extremity edema and venous insufficiency. However, no data are available for clinicians to assess the relative quality of various brands, particularly low-cost generics now available directly to consumers through the Internet. We examined the actual compression provided by gradient stockings from multiple manufacturers.
[Treatment of heart failure. A questionnaire among Norwegian hospital physicians]. [2015]A questionnaire on the treatment of congestive heart failure was distributed to physicians in the medical departments of five hospitals in the Oslo area. The 117 (81%) respondents selected first, second and third line therapy in the treatment of mild, moderate and severe heart failure. Diuretics and restrictions on sodium/water dominated as first line therapy for mild heart failure; less than 5% suggested ACE-inhibitors or digitalis. Some differences in priorities were revealed for moderate and severe heart failure. The majority again suggested diuretics and restrictions on sodium/water, but 20% preferred ACE-inhibitors, which were also stated as second or third line therapy by 60% of the physicians. Less than 50% chose digitalis or nitrates as one of the three first therapies.
Enalapril in the treatment of congestive heart failure. [2019]Congestive heart failure (CHF) is a complex clinical syndrome affecting 1% of the U.S. population. The basic dysfunction, a lack of sufficient blood flow to the periphery, triggers reflex neurohumoral mechanisms that cause systemic vasoconstriction and sodium and water retention as the body attempts to protect vital organs. This, in turn, results in additional work for the failing heart and further deterioration. Vasodilators, in general, and angiotensin converting enzyme (ACE) inhibitors, in particular, interrupt this pathophysiology and improve hemodynamics. Enalapril, a long-acting ACE inhibitor, has been demonstrated to improve New York Heart Association (NYHA) functional class, pulmonary capillary wedge pressure, cardiac index, maximum oxygen uptake, and exercise tolerance in CHF patients. Data from a recent trial provide evidence that a group of patients with severe CHF who were treated with enalapril showed reduced heart size, reduced need for other heart-failure medication, and reduced mortality.
Treatment of chronic congestive heart failure with captopril, an oral inhibitor of angiotensin-converting enzyme. [2013]The renin-angiotensin system is thought to maintain elevated systemic vascular resistance in heart failure. The hemodynamic effects of captopril (SQ 14225), an oral inhibitor of angiotensin-converting enzyme, were measured in 10 patients with stable congestive heart failure poorly controlled by digitalis and diuretics. At single daily doses of 25 to 150 mg, the cardiac index rose from 1.75 +/- 0.18 to 2.27 +/- 0.39 (mean +/- S.D.) liters per minute per square meter (P less than 0.001), and pulmonary-wedge pressure fell from 26.5 +/- 7.5 to 17.3 +/- 6.1 mm Hg (P less than 0.01). Systemic vascular resistance decreased from 2006 +/- 300 to 1393 +/- 238 dyne seconds per centimeter (P less than 0.001), and mean arterial pressure fell from 83.7 +/- 7.0 to 70.3 +/- 9.9 mm Hg (P less than 0.001) (mean +/- S.D.). Heart rate did not change appreciably. Hemodynamic alterations peaked at 90 minutes and persisted for three to four hours. Control plasma renin activity ranged from 1.1 to 7.3 ng per milliliter per hour and did not correlate with changes in hemodynamic values. Three patients on long-term treatment maintained clinical improvement. Although its mechanism of action has not been completely elucidated, captopril may prove useful in the treatment of chronic congestive heart failure.
Treatment of congestive heart failure: experience with fosinopril. [2019]The prevalence of congestive heart failure (CHF), a debilitating condition associated with impaired quality of life and markedly shortened life expectancy, is increasing. The goals of therapy for CHF are reducing symptoms, improving functional capacity, and slowing the progression of the condition. In most cases, this is best achieved with a combination of diuretic and vasodilator therapy. Angiotensin-converting enzyme (ACE) inhibitors have several advantages over other vasodilatory agents and are becoming widely used for treating CHF. The most recently introduced ACE inhibitor, fosinopril, is at least as effective as enalapril, and its dual and compensatory route of excretion is particularly advantageous in patients with renal insufficiency. Fosinopril may also have particular benefits in the prevention of CHF, as it has beneficial effects on cardiac function that may help delay the onset of overt cardiac failure.
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]Angiotensin-converting enzyme inhibitors and angiotensin receptor blockers improve prognosis in congestive heart failure and are the treatment of choice in these patients. Despite this, the rates of ACE-I usage in heart failure patients remain low in clinical practice.