Compression Wraps as Adjuvant Therapy in Management of Acute Systolic Heart Failure (CATAS-HF)

Compression Wraps as Adjuvant Therapy in the Management of Acute Systolic Heart Failure (CATAS-HF)

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.

Study Overview

• Status: Terminated
• Conditions: Heart Failure; With Decompensation
• Intervention / Treatment: Device: ACE compression wrap

Detailed Description

There will be two populations in this study: control group, and intervention group. 120 patients will be enrolled, 60 to group, randomized in 1:1 fashion. 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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention; Bilateral lower extremity ACE compression wraps in addition to standard medical care	Device: ACE compression wrap; Bilateral lower extremity ACE compression wraps
NO_INTERVENTION: Control; Standard medical care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Percentage of BNP Change	Assess the average percent of BNP reduction of intervention vs control groups	From admission to hospital discharge, up to 30 days
Average Pre-discharge BNP	Assess the average pre-discharge BNP of intervention vs control groups	From admission to hospital discharge, up to 30 days
Net Intake/Output of Fluids During Hospitalization	Assess the net intake/output across the hospitalization of intervention vs control groups, obtained through nursing documentation of fluid intake and output recorded daily during the hospitalization	From admission to hospital discharge, up to 30 days
IV Diuretic Infusion Used	Assess the use of IV diuretic in intervention vs control groups	From admission to hospital discharge, up to 30 days
Average Percentage of Weight Change During Hospitalization	Assess the average percent of weight reduction of intervention vs control groups	From admission to hospital discharge, up to 30 days
AKI During Hospitalization	Development of acute kidney injury during hospitalization	From admission to hospital discharge, up to 30 days

Collaborators and Investigators

• Sponsor: Henry Ford Health System

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 15, 2019
• Primary Completion (ACTUAL): March 2, 2020
• Study Completion (ACTUAL): January 21, 2021

Study Registration Dates

• First Submitted: August 13, 2019
• First Submitted That Met QC Criteria: September 17, 2019
• First Posted (ACTUAL): September 19, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 29, 2022
• Last Update Submitted That Met QC Criteria: March 17, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: edema; heart failure; systolic; Compression wraps; wrap
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Murmurs; Heart Failure; Systolic Murmurs; Heart Failure, Systolic
• Other Study ID Numbers: CATASHFtrial2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes