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NCT06350695 · ClinicalTrials.gov registry record · NA
The ROle of Compression StocKings in Heart Failure Patients
A NA study of Heart Failure, Congestive and Venous Insufficiency, sponsored by University of Maryland, Baltimore.
- Recruiting
- Registry status
- NA
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT06350695: Recruiting NA study of Heart Failure, Congestive and Venous Insufficiency, sponsored by University of Maryland, Baltimore.
NCT06350695 is a NA study of Heart Failure, Congestive and Venous Insufficiency that is actively recruiting participants, run by University of Maryland, Baltimore. The registered enrollment target is 50 participants, below the 674-participant average among 39 other Heart Failure, Congestive trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06350695, a NA study of Heart Failure, Congestive and Venous Insufficiency, is actively recruiting participants, sponsored by University of Maryland, Baltimore.
- RECRUITING
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
Congestive heart failure (CHF) occurs when the heart is weak and not able to effectively pump blood to the body. One of the common manifestations of CHF is fluid overload and swelling of the legs. Diuretics or "water pills" are usually the treatment for fluid overload and leg swelling; however, in some patients' diuretics are no longer effective or the effectiveness is limited due to poor kidney function. The presence of chronic swelling of the legs could potentially damage the veins; additionally, it could lead to chronic skin changes in the legs and in the worst cases to a leg ulcer. Compression stockings are used in patients with venous diseases to reduce the swelling of the legs and improve mobility and quality of life. Although, there is a theoretical risk that compression stockings might push the fluid of the legs back to the heart and lungs worsening the CHF. The purpose of this study is to determine whether the use of knee-high tight socks (tight stockings with strong compression) vs. knee-high soft socks (soft stockings with minimum compression) are effective in preventing swelling and skin changes and safe in patients with CHF. During the first visit (in-person) a routine medical test will be performed including blood tests, review of the medication doses, current weight, an ultrasound images of the veins, (venous reflux ultrasound), questions about health status and a brief physical exam. The participants will be randomly assigned to receive tight compression vs. soft compression socks. Participants will be asked to wear the socks at least 8 hours a day for 5 days a week. There will be a total of 3 virtual visit (by video or telephone); the first one after one week, then after one month and two months. During the virtual visit participants will be asked about symptoms, current medications and doses, and current weight. The participants are expected to return to the clinic after 3 months for a second in-person visit. During this visit the investigators wil
Primary Outcome
The number of adverse events (deaths and hospitalizations) will be recorded and compared between each group.
Conditions Studied
Interventions
- DEVICE low grade compression stockings (10-15 mmHg)
- DEVICE high grade compression stockings (20-30 mmHg)
Study Locations (1)
Texas
- University of Texas Southwestern Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2024-01-17 |
| Est. Completion | 2026-01-01 |
| Phase | NA |
What NCT06350695 shows while recruiting
NCT06350695 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 674-participant average among 39 other Heart Failure, Congestive trials with a reported enrollment target (93% lower).
The record links to 4 conditions, with Heart Failure, Congestive appearing as the primary indexed condition, and to 2 interventions - of which low grade compression stockings (10-15 mmHg) is the first listed.
NCT06350695 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT06350695 about?
NCT06350695 is a clinical study titled "The ROle of Compression StocKings in Heart Failure Patients". Congestive heart failure (CHF) occurs when the heart is weak and not able to effectively pump blood to the body. One of the common manifestations of CHF is fluid overload and swelling of the legs. Diuretics or "water pills" are usually the treatment for fluid overload and leg swelling; however, in s...
What is the current status of trial NCT06350695?
This trial is currently recruiting. It is a NA study. The enrollment target is 50 participants. The study started on 2024-01-17. Estimated completion is 2026-01-01.
What conditions does trial NCT06350695 study?
This clinical trial studies the following conditions: Heart Failure, Congestive, Venous Insufficiency, Venous Ulcers, Leg Edema.
What interventions are being tested in trial NCT06350695?
The interventions under investigation include: low grade compression stockings (10-15 mmHg) (DEVICE), high grade compression stockings (20-30 mmHg) (DEVICE).
Who is sponsoring clinical trial NCT06350695?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06350695 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Heart Failure, Congestive
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06350695's enrollment target sits among peer trials
50 30th of 39 higher than 10 of 39 other Heart Failure, Congestive trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Heart Failure, Congestive trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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