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NCT04095416 · ClinicalTrials.gov registry record · NA
Compression Wraps as Adjuvant Therapy in Management of Acute Systolic Heart Failure
A NA study, sponsored by Henry Ford Health System.
- Terminated
- Registry status
- NA
- Development phase
- 32
- Enrollment target
NCT04095416: Clinical Trial NA study, sponsored by Henry Ford Health System.
NCT04095416 is a NA study that was terminated before completion, run by Henry Ford Health System. The registered enrollment target is 32 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04095416, a NA study, was terminated before completion, sponsored by Henry Ford Health System.
- TERMINATED
- Registry status
- NA
- Development phase
- 32 participants
- Enrollment target
Study Summary
There will be two populations in this study: control group, and intervention group. These groups will undergo propensity matching to account for confounders and minimize selection bias. 120 patients will be enrolled, 60 to each population. The objective of this study is: assess the utility of lower extremity compression wraps as adjuvant therapy in inpatient management of acute systolic heart failure The control group will consist of patients admitted to I5 Cardiology for management of acute systolic heart failure with intravenous diuresis and standard medical therapy, meeting inclusion criteria. Information will be gathered through observational prospective data analysis from Epic EMR, and will include daily diuretic type and dose required, daily urine output, daily creatinine, total days of admission, daily and pre-discharge weight, admission BNP, and pre-discharge BNP. The intervention group will consist of patients admitted to I5 Cardiology meeting inclusion criteria and being managed with standard medical therapy. This group will receive additional therapy using bilateral lower extremity compression wraps applied by nursing staff per pre-set protocol, and will receive education on the use of compression wraps. Patients will be instructed to wear the compression wraps for the entirety of the time they are undergoing intravenous diuresis, with pauses in care as needed for hygiene and symptom relief purposes. During the time of compression wrap application, the following data will be collected: urine output, daily weights, daily creatinine, daily and total dose and type of intravenous diuretic used. Prior to discharge, a BNP will be obtained. Endpoints (including percentage of weight reduction, total urine output achieved with diuresis, total dose requirement and type of intravenous diuresis, total days of intravenous diuresis, days to discharge, discharge BNP, and percent reduction from admission BNP) will then be compared to assess the utility of adding lower
Primary Outcome
Assess rate of 30-day readmission of patients enrolled in study
Interventions
- DEVICE ACE compression wrap
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2019-08-15 |
| Est. Completion | 2021-01-21 |
| Phase | NA |
Why NCT04095416 stopped before completion
NCT04095416 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which ACE compression wrap is the first listed.
NCT04095416 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04095416 about?
NCT04095416 is a clinical study titled "Compression Wraps as Adjuvant Therapy in Management of Acute Systolic Heart Failure". There will be two populations in this study: control group, and intervention group. These groups will undergo propensity matching to account for confounders and minimize selection bias. 120 patients will be enrolled, 60 to each population. The objective of this study is: assess the utility of lower ...
What is the current status of trial NCT04095416?
This trial is currently terminated. It is a NA study. The enrollment target is 32 participants. The study started on 2019-08-15. Estimated completion is 2021-01-21.
What interventions are being tested in trial NCT04095416?
The interventions under investigation include: ACE compression wrap (DEVICE).
Who is sponsoring clinical trial NCT04095416?
This trial is sponsored by Henry Ford Health System, which has 234 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04095416's enrollment target sits among peer trials
32 1578th of 2000 higher than 409 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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