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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after 48 hours but before 72 hours after application of compression stocking
Awards & highlights
A-KHALIFE Trial 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.Check my eligibility
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.See study design
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.
A-KHALIFE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I was admitted for worsening heart failure and have swelling in my legs.
A-KHALIFE Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Length of stay in the hospital
Secondary outcome measures
Cardiovascular deaths
Change in serum BNP level at discharge in comparison to admission
Death from all causes
+7 moreA-KHALIFE 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.
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Who is running the clinical trial?
The University of Texas Medical Branch, GalvestonLead Sponsor
243 Previous Clinical Trials
56,571 Total Patients Enrolled
Wissam I Khalife, MDPrincipal InvestigatorUniversity of Texas Medical Branch, Galveston
Salman Salehin, MDPrincipal InvestigatorUniversity of Texas Medical Branch, Galveston
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I was diagnosed with a blood clot in my leg or lung in the last 3 months.You need mechanical help for your heart, like a balloon pump or impella.I cannot use lower limb compression due to a condition like amputation or chronic wounds.It will be difficult for you to provide information about your health 12 weeks after the study starts.I have severe artery blockage in my legs.I need a lot of oxygen or use a machine to help me breathe.I need medication through an IV to help my heart pump blood.I was admitted for worsening heart failure and have swelling in my legs.I am under 18 years old.Your blood pressure is lower than 80 mmHg when your heart beats.I am currently on dialysis.You are currently using a ventricular assist device.
Research Study Groups:
This trial has the following groups:- Group 1: Control Arm
- Group 2: Interventional: Compression Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment still accessible for this trial?
"Affirmative. Clinicaltrials.gov details suggest that this clinical trial is still recruiting participants, with the first post being on April 30th 2022 and most recent update occurring on July 20th 2022. A total of 100 individuals are needed from a single location."
Answered by AI
How many individuals are being monitored as part of this inquiry?
"Affirmative. Details found on clinicaltrials.gov reveal that this investigation is actively looking for individuals to participate in its research activities, which were initially posted April 30th 2022 and last updated July 20th 2022. The study has the capacity to enrol 100 participants from a single site of operations."
Answered by AI
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