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NCT05467735 · ClinicalTrials.gov registry record · NA
Above-Knee-High Application of Lower Limb Compression and Its Impact on Clinical Outcome in Patients Hospitalized With Heart Failure Exacerbation.
A NA study, sponsored by The University of Texas Medical Branch, Galveston.
- Terminated
- Registry status
- NA
- Development phase
- 20
- Enrollment target
NCT05467735 is a NA study that was terminated before completion, run by The University of Texas Medical Branch, Galveston. The registered enrollment target is 20 participants.
The verdict
NCT05467735, a NA study, was terminated before completion, sponsored by The University of Texas Medical Branch, Galveston.
- TERMINATED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
Study 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 pat
Interventions
- OTHER Application of compression to bilateral lower extremities of patients using appropriately-sized elastic compression stockings.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2022-04-30 |
| Est. Completion | 2024-09-10 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05467735
The ClinicalTrials.gov registry entry for NCT05467735 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The University of Texas Medical Branch, Galveston, which has 203 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Application of compression to bilateral lower extremities of patients using appropriately-sized elastic compression stockings. is the first listed.
NCT05467735 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05467735 about?
NCT05467735 is a clinical study titled "Above-Knee-High Application of Lower Limb Compression and Its Impact on Clinical Outcome in Patients Hospitalized With Heart Failure Exacerbation.". 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. Th...
What is the current status of trial NCT05467735?
This trial is currently terminated. It is a NA study. The enrollment target is 20 participants. The study started on 2022-04-30. Estimated completion is 2024-09-10.
What interventions are being tested in trial NCT05467735?
The interventions under investigation include: Application of compression to bilateral lower extremities of patients using appropriately-sized elastic compression stockings. (OTHER).
Who is sponsoring clinical trial NCT05467735?
This trial is sponsored by The University of Texas Medical Branch, Galveston, which has 203 total clinical trials registered on ClinicalTrials.gov.
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