Application of compression to bilateral lower extremities of patients using appropriately-sized elastic compression stockings. for Heart failure

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Texas Medical Branch (UTMB) Galveston, Galveston, TX
Heart failure+3 More
Application of compression to bilateral lower extremities of patients using appropriately-sized elastic compression stockings. - Other
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

Heart failure (HF) remains one of the most common causes of hospitalization with high morbidity and mortality, and its worldwide prevalence is increasing. Despite notable progress in outcomes for HF the rate of early rehospitalization for HF (re-HHF) remains high, especially in the first 30 days. The rate of 30-day HF rehospitalization in the claims databases of the USA and in worldwide randomized clinical trials is 20-25% and 5-10% respectively. In patients with bilateral leg edema, the presence of CHF (congestive heart failure) as the factor causing or worsening local leg swelling should be evaluated. Application of local leg compression can be considered in stable CHF patients without decompensated heart function (NYHA Class I and II) for both CHF-related edema treatment and for treatment of concomitant diseases leading to leg swelling occurrence. Current literature does not have recommendations on the routine use of lower limb compression in leg swelling related to end stage heart disease and advanced, decompensated heart failure. Potential benefits of applying medical compression in more severe classes of CHF (NYHA Class III and IV) would need to be evaluated by further randomized clinical studies to determine which cohort of patients would benefit most from lower limb compression, as well as to choose the safest and most efficient compression protocol for these patients. The AIM of this study is to improve the clinical outcome of patients admitted with exacerbation of heart failure with associated volume overload. The primary objectives are: 1) diminish the duration of hospitalization of CHF patients; 2) decrease the incidence of rehospitalization from CHF exacerbation and 3) prevent local complications associated with prolonged lower extremity edema. The investigators hypothesize that the application of local compression to bilateral lower extremities, when added to guideline-based therapy for CHF exacerbation, will improve overall clinical outcome in patients at the University of Texas Medical Branch (UTMB). If our intervention is proven to be beneficial, it could lead to a significant reduction in nationwide hospitalization costs associated with heart failure.

Eligible Conditions

  • Heart failure
  • Edema

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Heart failure

Study Objectives

1 Primary · 10 Secondary · Reporting Duration: after 48 hours but before 72 hours after application of compression stocking

Day 90
Cardiovascular deaths
Day 90
Death from all causes
Day 90
Major adverse cardiac event within 30 days of discharge from index hospitalization
Day 30
Incidence of 30-day rehospitalization
Day 90
Incidence of 90-day rehospitalization
Up to 60 days
Incidence of AKI
Hour 72
Incidence of orthostatic hypotension
up to 30 days
Duration of IV diuretics therapy
up to 60 days
Change in serum BNP level at discharge in comparison to admission
Incidence of cutaneous lesions following application of compression stockings.
Length of stay in the hospital

Trial Safety

Safety Progress

1 of 3

Other trials for Heart failure

Trial Design

2 Treatment Groups

Control Arm
1 of 2
Interventional: Compression Arm
1 of 2
Active Control
Experimental Treatment

100 Total Participants · 2 Treatment Groups

Primary Treatment: Application of compression to bilateral lower extremities of patients using appropriately-sized elastic compression stockings. · No Placebo Group · N/A

Interventional: Compression Arm
Other
Experimental Group · 1 Intervention: Application of compression to bilateral lower extremities of patients using appropriately-sized elastic compression stockings. · Intervention Types: Other
Control ArmNoIntervention Group · 1 Intervention: Control Arm · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: after 48 hours but before 72 hours after application of compression stocking
Closest Location: University of Texas Medical Branch (UTMB) Galveston · Galveston, TX
Photo of texas 1Photo of texas 2Photo of texas 3
N/AFirst Recorded Clinical Trial
0 TrialsResearching Heart failure
0 CompletedClinical Trials

Who is running the clinical trial?

The University of Texas Medical Branch, GalvestonLead Sponsor
220 Previous Clinical Trials
55,013 Total Patients Enrolled
Salman Salehin, MDPrincipal InvestigatorUniversity of Texas Medical Branch, Galveston
Wissam I Khalife, MDPrincipal InvestigatorUniversity of Texas Medical Branch, Galveston

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References