Trial Outcomes & Findings for Compression Wraps as Adjuvant Therapy in Management of Acute Systolic Heart Failure (NCT NCT04095416)

NCT ID: NCT04095416

Last Updated: 2022-03-29

Results Overview

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

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 32 participants
• Primary outcome timeframe: 30 days from hospital discharge
• Results posted on: 2022-03-29

Participant Flow

Enrollment terminated early due to COVID-19 pandemic

Participant milestones

Measure	Intervention Bilateral lower extremity compression wraps in addition to standard medical care Compression wrap: Bilateral lower extremity compression wraps applied by trained research team	Control Standard medical care
Overall Study STARTED	13	19
Overall Study COMPLETED	10	19
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Intervention n=10 Participants Adult patients age 18 years or older with a history of chronic heart failure (functional class II, III, or IV) with a left ventricular ejection fraction of 40% or less as determined by echocardiography within 6 months of evaluation, were eligible for enrollment in the trial. Final inclusion criteria required admission to the telemetry unit for intravenous (IV) diuretic therapy in the management of acute decompensated heart failure, and presence of lower extremity pitting edema on physical examination. Bilateral lower extremity compression wraps in addition to standard medical care Compression wrap: Bilateral lower extremity compression wraps applied by trained research team	Control n=19 Participants Adult patients age 18 years or older with a history of chronic heart failure (functional class II, III, or IV) with a left ventricular ejection fraction of 40% or less as determined by echocardiography within 6 months of evaluation, were eligible for enrollment in the trial. Final inclusion criteria required admission to the telemetry unit for intravenous (IV) diuretic therapy in the management of acute decompensated heart failure, and presence of lower extremity pitting edema on physical examination. Standard medical care	Total n=29 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=93 Participants	8 Participants n=4 Participants	12 Participants n=27 Participants
Age, Categorical >=65 years	6 Participants n=93 Participants	11 Participants n=4 Participants	17 Participants n=27 Participants
Age, Continuous	63 years STANDARD_DEVIATION 16 • n=93 Participants	64 years STANDARD_DEVIATION 12 • n=4 Participants	64 years STANDARD_DEVIATION 13 • n=27 Participants
Sex: Female, Male Female	3 Participants n=93 Participants	4 Participants n=4 Participants	7 Participants n=27 Participants
Sex: Female, Male Male	7 Participants n=93 Participants	15 Participants n=4 Participants	22 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	6 Participants n=93 Participants	12 Participants n=4 Participants	18 Participants n=27 Participants
Race (NIH/OMB) White	4 Participants n=93 Participants	7 Participants n=4 Participants	11 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Admission weight	98.3 kg STANDARD_DEVIATION 30.9 • n=93 Participants	91.2 kg STANDARD_DEVIATION 21.3 • n=4 Participants	93.7 kg STANDARD_DEVIATION 24.7 • n=27 Participants
Admission BNP	2279 pg/mL STANDARD_DEVIATION 1613 • n=93 Participants	1997 pg/mL STANDARD_DEVIATION 1296 • n=4 Participants	2095 pg/mL STANDARD_DEVIATION 1391 • n=27 Participants
Ejection fraction, baseline	32 % STANDARD_DEVIATION 10 • n=93 Participants	26 % STANDARD_DEVIATION 9 • n=4 Participants	28 % STANDARD_DEVIATION 10 • n=27 Participants

PRIMARY outcome

Timeframe: 30 days from hospital discharge

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

Outcome measures

Measure	Intervention n=10 Participants Adult patients age 18 years or older with a history of chronic heart failure (functional class II, III, or IV) with a left ventricular ejection fraction of 40% or less as determined by echocardiography within 6 months of evaluation, were eligible for enrollment in the trial. Final inclusion criteria required admission to the telemetry unit for intravenous (IV) diuretic therapy in the management of acute decompensated heart failure, and presence of lower extremity pitting edema on physical examination. Bilateral lower extremity compression wraps in addition to standard medical care Compression wrap: Bilateral lower extremity compression wraps applied by trained research team	Control n=19 Participants Adult patients age 18 years or older with a history of chronic heart failure (functional class II, III, or IV) with a left ventricular ejection fraction of 40% or less as determined by echocardiography within 6 months of evaluation, were eligible for enrollment in the trial. Final inclusion criteria required admission to the telemetry unit for intravenous (IV) diuretic therapy in the management of acute decompensated heart failure, and presence of lower extremity pitting edema on physical examination. Standard medical care
Number of Participants With Readmission Within 30-days	2 Participants	5 Participants

PRIMARY outcome

Timeframe: From admission to hospital discharge, up to 30 days

Assess the length of hospitalization, controlling for variables

Outcome measures

Measure	Intervention n=10 Participants Adult patients age 18 years or older with a history of chronic heart failure (functional class II, III, or IV) with a left ventricular ejection fraction of 40% or less as determined by echocardiography within 6 months of evaluation, were eligible for enrollment in the trial. Final inclusion criteria required admission to the telemetry unit for intravenous (IV) diuretic therapy in the management of acute decompensated heart failure, and presence of lower extremity pitting edema on physical examination. Bilateral lower extremity compression wraps in addition to standard medical care Compression wrap: Bilateral lower extremity compression wraps applied by trained research team	Control n=19 Participants Adult patients age 18 years or older with a history of chronic heart failure (functional class II, III, or IV) with a left ventricular ejection fraction of 40% or less as determined by echocardiography within 6 months of evaluation, were eligible for enrollment in the trial. Final inclusion criteria required admission to the telemetry unit for intravenous (IV) diuretic therapy in the management of acute decompensated heart failure, and presence of lower extremity pitting edema on physical examination. Standard medical care
Total Length of Hospital Stay	4.6 days Standard Deviation 2.6	7.4 days Standard Deviation 3.9

PRIMARY outcome

Timeframe: From admission to hospital discharge, up to 30 days

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

Outcome measures

Measure	Intervention n=10 Participants Adult patients age 18 years or older with a history of chronic heart failure (functional class II, III, or IV) with a left ventricular ejection fraction of 40% or less as determined by echocardiography within 6 months of evaluation, were eligible for enrollment in the trial. Final inclusion criteria required admission to the telemetry unit for intravenous (IV) diuretic therapy in the management of acute decompensated heart failure, and presence of lower extremity pitting edema on physical examination. Bilateral lower extremity compression wraps in addition to standard medical care Compression wrap: Bilateral lower extremity compression wraps applied by trained research team	Control n=19 Participants Adult patients age 18 years or older with a history of chronic heart failure (functional class II, III, or IV) with a left ventricular ejection fraction of 40% or less as determined by echocardiography within 6 months of evaluation, were eligible for enrollment in the trial. Final inclusion criteria required admission to the telemetry unit for intravenous (IV) diuretic therapy in the management of acute decompensated heart failure, and presence of lower extremity pitting edema on physical examination. Standard medical care
Days on IV Diuretic Therapy	4.2 days Standard Deviation 3.1	5.0 days Standard Deviation 1.8

SECONDARY outcome

Timeframe: From admission to hospital discharge, up to 30 days

Assess the average percent of BNP reduction of intervention vs control groups

Outcome measures

Measure	Intervention n=10 Participants Adult patients age 18 years or older with a history of chronic heart failure (functional class II, III, or IV) with a left ventricular ejection fraction of 40% or less as determined by echocardiography within 6 months of evaluation, were eligible for enrollment in the trial. Final inclusion criteria required admission to the telemetry unit for intravenous (IV) diuretic therapy in the management of acute decompensated heart failure, and presence of lower extremity pitting edema on physical examination. Bilateral lower extremity compression wraps in addition to standard medical care Compression wrap: Bilateral lower extremity compression wraps applied by trained research team	Control n=19 Participants Adult patients age 18 years or older with a history of chronic heart failure (functional class II, III, or IV) with a left ventricular ejection fraction of 40% or less as determined by echocardiography within 6 months of evaluation, were eligible for enrollment in the trial. Final inclusion criteria required admission to the telemetry unit for intravenous (IV) diuretic therapy in the management of acute decompensated heart failure, and presence of lower extremity pitting edema on physical examination. Standard medical care
Average Percentage of BNP Change	-38.5 % change Standard Deviation 22.8	-38.2 % change Standard Deviation 57.6

SECONDARY outcome

Timeframe: From admission to hospital discharge, up to 30 days

Assess the average pre-discharge BNP of intervention vs control groups

Outcome measures

Measure	Intervention n=10 Participants Adult patients age 18 years or older with a history of chronic heart failure (functional class II, III, or IV) with a left ventricular ejection fraction of 40% or less as determined by echocardiography within 6 months of evaluation, were eligible for enrollment in the trial. Final inclusion criteria required admission to the telemetry unit for intravenous (IV) diuretic therapy in the management of acute decompensated heart failure, and presence of lower extremity pitting edema on physical examination. Bilateral lower extremity compression wraps in addition to standard medical care Compression wrap: Bilateral lower extremity compression wraps applied by trained research team	Control n=19 Participants Adult patients age 18 years or older with a history of chronic heart failure (functional class II, III, or IV) with a left ventricular ejection fraction of 40% or less as determined by echocardiography within 6 months of evaluation, were eligible for enrollment in the trial. Final inclusion criteria required admission to the telemetry unit for intravenous (IV) diuretic therapy in the management of acute decompensated heart failure, and presence of lower extremity pitting edema on physical examination. Standard medical care
Average Pre-discharge BNP	1404 pg/mL Standard Deviation 1441	1238 pg/mL Standard Deviation 896

SECONDARY outcome

Timeframe: From admission to hospital discharge, up to 30 days

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

Outcome measures

Measure	Intervention n=10 Participants Adult patients age 18 years or older with a history of chronic heart failure (functional class II, III, or IV) with a left ventricular ejection fraction of 40% or less as determined by echocardiography within 6 months of evaluation, were eligible for enrollment in the trial. Final inclusion criteria required admission to the telemetry unit for intravenous (IV) diuretic therapy in the management of acute decompensated heart failure, and presence of lower extremity pitting edema on physical examination. Bilateral lower extremity compression wraps in addition to standard medical care Compression wrap: Bilateral lower extremity compression wraps applied by trained research team	Control n=19 Participants Adult patients age 18 years or older with a history of chronic heart failure (functional class II, III, or IV) with a left ventricular ejection fraction of 40% or less as determined by echocardiography within 6 months of evaluation, were eligible for enrollment in the trial. Final inclusion criteria required admission to the telemetry unit for intravenous (IV) diuretic therapy in the management of acute decompensated heart failure, and presence of lower extremity pitting edema on physical examination. Standard medical care
Net Intake/Output of Fluids During Hospitalization	-8.13 L Standard Deviation 8.05	-7.08 L Standard Deviation 6.21

SECONDARY outcome

Timeframe: From admission to hospital discharge, up to 30 days

Assess the use of IV diuretic in intervention vs control groups

Outcome measures

Measure	Intervention n=10 Participants Adult patients age 18 years or older with a history of chronic heart failure (functional class II, III, or IV) with a left ventricular ejection fraction of 40% or less as determined by echocardiography within 6 months of evaluation, were eligible for enrollment in the trial. Final inclusion criteria required admission to the telemetry unit for intravenous (IV) diuretic therapy in the management of acute decompensated heart failure, and presence of lower extremity pitting edema on physical examination. Bilateral lower extremity compression wraps in addition to standard medical care Compression wrap: Bilateral lower extremity compression wraps applied by trained research team	Control n=19 Participants Adult patients age 18 years or older with a history of chronic heart failure (functional class II, III, or IV) with a left ventricular ejection fraction of 40% or less as determined by echocardiography within 6 months of evaluation, were eligible for enrollment in the trial. Final inclusion criteria required admission to the telemetry unit for intravenous (IV) diuretic therapy in the management of acute decompensated heart failure, and presence of lower extremity pitting edema on physical examination. Standard medical care
IV Diuretic Infusion Used	0 Participants	7 Participants

SECONDARY outcome

Timeframe: From admission to hospital discharge, up to 30 days

Assess the average percent of weight reduction of intervention vs control groups

Outcome measures

Measure	Intervention n=10 Participants Adult patients age 18 years or older with a history of chronic heart failure (functional class II, III, or IV) with a left ventricular ejection fraction of 40% or less as determined by echocardiography within 6 months of evaluation, were eligible for enrollment in the trial. Final inclusion criteria required admission to the telemetry unit for intravenous (IV) diuretic therapy in the management of acute decompensated heart failure, and presence of lower extremity pitting edema on physical examination. Bilateral lower extremity compression wraps in addition to standard medical care Compression wrap: Bilateral lower extremity compression wraps applied by trained research team	Control n=19 Participants Adult patients age 18 years or older with a history of chronic heart failure (functional class II, III, or IV) with a left ventricular ejection fraction of 40% or less as determined by echocardiography within 6 months of evaluation, were eligible for enrollment in the trial. Final inclusion criteria required admission to the telemetry unit for intravenous (IV) diuretic therapy in the management of acute decompensated heart failure, and presence of lower extremity pitting edema on physical examination. Standard medical care
Average Percentage of Weight Change During Hospitalization	-7.2 % change Standard Deviation 6.1	-5.7 % change Standard Deviation 5.2

SECONDARY outcome

Timeframe: From admission to hospital discharge, up to 30 days

Development of acute kidney injury during hospitalization

Outcome measures

Measure	Intervention n=10 Participants Adult patients age 18 years or older with a history of chronic heart failure (functional class II, III, or IV) with a left ventricular ejection fraction of 40% or less as determined by echocardiography within 6 months of evaluation, were eligible for enrollment in the trial. Final inclusion criteria required admission to the telemetry unit for intravenous (IV) diuretic therapy in the management of acute decompensated heart failure, and presence of lower extremity pitting edema on physical examination. Bilateral lower extremity compression wraps in addition to standard medical care Compression wrap: Bilateral lower extremity compression wraps applied by trained research team	Control n=19 Participants Adult patients age 18 years or older with a history of chronic heart failure (functional class II, III, or IV) with a left ventricular ejection fraction of 40% or less as determined by echocardiography within 6 months of evaluation, were eligible for enrollment in the trial. Final inclusion criteria required admission to the telemetry unit for intravenous (IV) diuretic therapy in the management of acute decompensated heart failure, and presence of lower extremity pitting edema on physical examination. Standard medical care
AKI During Hospitalization	1 Participants	13 Participants

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Raef Ali Fadel

Henry Ford Hospital

Phone: 3139321347

Email: rfadel2@hfhs.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place