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Elastic Compression Stockings for Heart Failure (A-KHALIFE Trial)

N/A

Recruiting

Led By Wissam I Khalife, MD

Research Sponsored by The University of Texas Medical Branch, Galveston

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients who are admitted with heart failure exacerbation with clinical evidence of volume overload in the form of lower extremity pitting edema.

Be older than 18 years old

Must not have

Impossibility to perform lower extremity compression, caused by pathology in either or both lower limbs (e.g. amputation, chronic wounds).

Severe peripheral artery disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after 48 hours but before 72 hours after application of compression stocking

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether applying local leg compression to patients with congestive heart failure (CHF) in addition to standard care will reduce hospitalization time and the number of rehospitalizations for CHF.

Who is the study for?

This trial is for adults hospitalized with heart failure exacerbation and swelling in the lower legs. It's not for those under 18, on dialysis, using certain breathing aids or high oxygen levels, in cardiogenic shock, with very low blood pressure, on a Ventricular Assist Device (VAD), recent deep vein thrombosis or pulmonary embolism patients, pregnant women, or those with severe artery disease.

What is being tested?

The study tests if applying compression stockings to both lower legs of heart failure patients can reduce hospital stay duration and rehospitalization rates while preventing complications from prolonged leg swelling. This will be added to standard treatment guidelines for heart failure.

What are the potential side effects?

While the trial description does not specify side effects of leg compression stockings directly, potential risks may include discomfort, skin irritation or breakdown especially if improperly fitted or used inappropriately.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I was admitted for worsening heart failure and have swelling in my legs.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot use lower limb compression due to a condition like amputation or chronic wounds.

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I have severe artery blockage in my legs.

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I need a lot of oxygen or use a machine to help me breathe.

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I need medication through an IV to help my heart pump blood.

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I am under 18 years old.

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I am currently on dialysis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ after 48 hours but before 72 hours after application of compression stocking

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~after 48 hours but before 72 hours after application of compression stocking

This trial's timeline: 3 weeks for screening, Varies for treatment, and after 48 hours but before 72 hours after application of compression stocking for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Length of stay in the hospital

Secondary study objectives

Cardiovascular deaths

Change in serum BNP level at discharge in comparison to admission

Death from all causes

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Interventional: Compression ArmExperimental Treatment1 Intervention

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.

Group II: Control ArmActive Control1 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.

0 / 7Eligibility criteria met