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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 is a NA study that was terminated before completion, run by Henry Ford Health System. The registered enrollment target is 32 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04095416
The ClinicalTrials.gov registry entry for NCT04095416 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Henry Ford Health System, which has 234 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which ACE compression wrap is the first listed.
NCT04095416 reports 0 study locations.
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.
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