Above-Knee-High Application of Lower Limb Compression and Its Impact on Clinical Outcome in Patients Hospitalized With Heart Failure Exacerbation.

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.

Conditions

• Heart Failure; With Decompensation
• Lower Extremity Edema
• Heart Failure，Congestive

Interventions

OTHER

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

Patients in the Compression group would be subject to application of standardized lower extremity, thigh-high, elastic compression stockings within 24 hours of admission. Appropriate size of the stockings would be based on calf circumference, thigh circumference and leg length. The compression would be applied throughout the entire duration of hospitalization, provided the patient is able to tolerate it. Daily thorough skin checks for any cutaneous defects or lesions will be performed, and mobilization encouraged.

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston

  lead OTHER

Principal Investigators

• Wissam I Khalife, MD · University of Texas Medical Branch, Galveston

• Salman Salehin, MD · University of Texas Medical Branch, Galveston

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-04-30

Primary Completion

2024-09-10

Completion

2024-09-10

Countries

• United States

Study Locations