Compression Wraps as Adjuvant Therapy in Management of Acute Systolic Heart Failure

NCT04095416 | Terminated Results DMC FDA Device

• 1 other identifier: CATASHFtrial2019
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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 extremity compression wraps to inpatient management of acute systolic heart failure.

Conditions

Heart Failure; With Decompensation

Keywords

Compression wraps; heart failure; systolic; edema; wrap

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Readmission Within 30-days

  Assess rate of 30-day readmission of patients enrolled in study

  30 days from hospital discharge

• Total Length of Hospital Stay

  Assess the length of hospitalization, controlling for variables

  From admission to hospital discharge, up to 30 days

• Days on IV Diuretic Therapy

  Assess the number of days from start of IV diuresis to transition to PO diuresis

  From admission to hospital discharge, up to 30 days

Secondary Outcomes (6)

• Average Percentage of BNP Change

  From admission to hospital discharge, up to 30 days

• Average Pre-discharge BNP

  From admission to hospital discharge, up to 30 days

• Net Intake/Output of Fluids During Hospitalization

  From admission to hospital discharge, up to 30 days

• IV Diuretic Infusion Used

  From admission to hospital discharge, up to 30 days

• Average Percentage of Weight Change During Hospitalization

  From admission to hospital discharge, up to 30 days

Study Arms (2)

Intervention

EXPERIMENTAL

Bilateral lower extremity ACE compression wraps in addition to standard medical care

Device: ACE compression wrap

Control

NO INTERVENTION

Standard medical care

Interventions

ACE compression wrap DEVICE

Bilateral lower extremity ACE compression wraps

Intervention

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age greater than 18 and less than 85 years of age
• admitted to I5 with Acute Systolic Heart Failure with an ejection fraction of less than 50% as determined by echocardiogram within 6 months
• requiring inpatient management with intravenous diuresis.
• diagnosis of acute systolic heart failure, of any underlying etiology
• at least 2+ pitting edema (or documented lower extremity pitting edema of at least moderate or significant severity) on primary assessment.

You may not qualify if:

• cannot tolerate IV diuresis
• who cannot wear or tolerate lower extremity compression stockings or wraps
• ESRD
• peripheral neuropathy
• ejection fraction greater than 50% as evaluated by echocardiogram within 6 months

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Heart Failure; Systolic Murmurs; Edema

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Heart Murmurs; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Raef Ali Fadel
• Organization: Henry Ford Hospital

rfadel2@hfhs.org

3139321347

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Emergency Medicine, Internal Medicine Physician

Model Details: Two arms, one interventional group and one control. Interventional group receives compression wraps and standard medical care, control group only receives standard medical care

Study Record Dates

• First Submitted: August 13, 2019
• First Posted: September 19, 2019
• Study Start: August 15, 2019
• Primary Completion: March 2, 2020
• Study Completion: January 21, 2021
• Last Updated: March 29, 2022
• Results First Posted: February 24, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)