TERMINATED

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

Conditions

Heart Failure; With Decompensation Lower Extremity Edema Heart Failure，Congestive Heart failure with decompensation Compression stockings Lower extremity compression

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-04-30

Study Completion:2024-09-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:TERMINATED

Study ID

NCT05467735

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Patients who are admitted with heart failure exacerbation with clinical evidence of volume overload in the form of lower extremity pitting edema. 2. Patients who are not yet recruited for other pharmacological or medical device clinical trials.	1. Age \<18 years. 2. Patient on hemodialysis or peritoneal dialysis. 3. Simultaneous participation in another interventional study. 4. Impossibility to perform lower extremity compression, caused by pathology in either or both lower limbs (e.g. amputation, chronic wounds). 5. No written informed consent. 6. Patient who are on invasive or non-invasive positive pressure ventilation (including BiPAP) or who are requiring \>15L of oxygen. 7. Cardiogenic shock requiring catecholamine infusion. 8. Systolic blood pressure \<80 mmHg. 9. Patients requiring mechanical circulatory support including intra-aortic balloon counter-pulsation or impella. 10. Patients on VAD (Ventricular Assist Device). 11. Severe peripheral artery disease 12. Diagnosis of lower extremity deep venous thrombosis or pulmonary embolism in the last 3 months 13. Expected impossibility to obtain follow-up data at 12-week follow-up. 14. Pregnant women.

Inclusion Criteria

Exclusion Criteria

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

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

Contacts and Locations

Principal Investigator

Wissam I Khalife, MD

PRINCIPAL_INVESTIGATOR

University of Texas Medical Branch, Galveston

Salman Salehin, MD

PRINCIPAL_INVESTIGATOR

University of Texas Medical Branch, Galveston

Study Locations (Sites)

University of Texas Medical Branch (UTMB) Galveston

Galveston, Texas, 77555

United States

Collaborators and Investigators

Sponsor: The University of Texas Medical Branch, Galveston

Wissam I Khalife, MD, PRINCIPAL_INVESTIGATOR, University of Texas Medical Branch, Galveston
Salman Salehin, MD, PRINCIPAL_INVESTIGATOR, University of Texas Medical Branch, Galveston

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-30

Study Completion Date2024-09-10

Study Record Updates

Study Start Date2022-04-30

Study Completion Date2024-09-10

Terms related to this study

Keywords Provided by Researchers

Heart failure with decompensation
Compression stockings
Lower extremity compression

Additional Relevant MeSH Terms

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