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

NCT05467735 | Terminated

• 1 other identifier: 22-0058
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Heart failure with decompensation; Compression stockings; Lower extremity compression

Outcome Measures

Primary Outcomes (1)

• Length of stay in the hospital

  Calculated by subtracting the day of admission from day of discharge.

  up to 60 days

Secondary Outcomes (10)

• Incidence of 30-day rehospitalization

  The incidence of rehospitalization or readmission within the first 30 days after discharge

• Incidence of 90-day rehospitalization

  The incidence of rehospitalization or readmission within the first 90 days after discharge

• Death from all causes

  Death from all causes within the first 30 days as well as within the first 90 days after discharge from index hospitalization

• Cardiovascular deaths

  Cardiovascular deaths within the first 30 days as well as within the first 90 days after discharge from index hospitalization

• Major adverse cardiac event within 30 days of discharge from index hospitalization

  Major adverse cardiac event within the first 30 days as well as within the first 90 days after discharge from index hospitalization

Study Arms (2)

Interventional: Compression Arm

EXPERIMENTAL

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.

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

Control Arm

NO INTERVENTION

The inflatable sleeves of a sequential compression device would be placed in bilateral lower extremities of patients, but the device would not be turned on, thus no external pressure would be applied.

Interventions

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

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.

Interventional: Compression Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are admitted with heart failure exacerbation with clinical evidence of volume overload in the form of lower extremity pitting edema.
• Patients who are not yet recruited for other pharmacological or medical device clinical trials.

You may not qualify if:

• Age \<18 years.
• Patient on hemodialysis or peritoneal dialysis.
• Simultaneous participation in another interventional study.
• Impossibility to perform lower extremity compression, caused by pathology in either or both lower limbs (e.g. amputation, chronic wounds).
• No written informed consent.
• Patient who are on invasive or non-invasive positive pressure ventilation (including BiPAP) or who are requiring \>15L of oxygen.
• Cardiogenic shock requiring catecholamine infusion.
• Systolic blood pressure \<80 mmHg.
• Patients requiring mechanical circulatory support including intra-aortic balloon counter-pulsation or impella.
• Patients on VAD (Ventricular Assist Device).
• Severe peripheral artery disease
• Diagnosis of lower extremity deep venous thrombosis or pulmonary embolism in the last 3 months
• Expected impossibility to obtain follow-up data at 12-week follow-up.
• Pregnant women.

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

University of Texas Medical Branch (UTMB) Galveston

Galveston, Texas, 77555, United States

Location

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MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Wissam I Khalife, MD

  University of Texas Medical Branch, Galveston

  PRINCIPAL INVESTIGATOR

• Salman Salehin, MD

  University of Texas Medical Branch, Galveston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2022
• First Posted: July 20, 2022
• Study Start: April 30, 2022
• Primary Completion: September 10, 2024
• Study Completion: September 10, 2024
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)