Heart Failure; With DecompensationCATAS-HFNCT04095416
Compression Wraps as Adjuvant Therapy in Management of Acute Systolic Heart Failure
A study testing ACE compression wrap in people with Heart Failure; With Decompensation, run by Henry Ford Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Heart Failure; With Decompensation
- What is being tested?
- ACE compression wrap
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2019to 21 Jan 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Heart Failure; With Decompensation
- Being tested
- ACE compression wrap
- Keywords
- Compression wraps, heart failure, systolic, edema, wrap
- Medical subject headings
- Heart Failure, Systolic Murmurs, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACE compression wrapDevice
Bilateral lower extremity ACE compression wraps
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Bilateral lower extremity ACE compression wraps in addition to standard medical care Receives: Device: ACE compression wrap |
| Control | No intervention | Standard medical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Readmission Within 30-days
Assess rate of 30-day readmission of patients enrolled in study
Measured: 30 days from hospital discharge
Total Length of Hospital Stay
Assess the length of hospitalization, controlling for variables
Measured: 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
Measured: From admission to hospital discharge, up to 30 days
Secondary outcomes (6)
Average Percentage of BNP Change
Assess the average percent of BNP reduction of intervention vs control groups
Measured: From admission to hospital discharge, up to 30 days
Average Pre-discharge BNP
Assess the average pre-discharge BNP of intervention vs control groups
Measured: 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
Measured: From admission to hospital discharge, up to 30 days
IV Diuretic Infusion Used
Assess the use of IV diuretic in intervention vs control groups
Measured: 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
Measured: From admission to hospital discharge, up to 30 days
AKI During Hospitalization
Development of acute kidney injury during hospitalization
Measured: From admission to hospital discharge, up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start15 Aug 2019
- Primary completion2 Mar 2020
- Study completion21 Jan 2021
Why it stopped: challenges in recruitment due to covid-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart Failure; With DecompensationStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two arms, one interventional group and one control. Interventional group receives compression wraps and standard medical care, control group only receives standard medical care
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Miller, MD, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04095416
- Sponsor's protocol ID
- CATASHFtrial2019
- Acronym
- CATAS-HF
- Status last verified
- Mar 2022
- First submitted
- 13 Aug 2019
- Last updated
- 29 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compression Wraps as Adjuvant Therapy in the Management of Acute Systolic Heart Failure (CATAS-HF)
- ClinicalTrials.gov ID
- NCT04095416
- Acronym / sponsor ID
- CATAS-HF / CATASHFtrial2019
- Conditions
- Heart Failure; With Decompensation
- Keywords
- Compression wraps, heart failure, systolic, edema, wrap
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: challenges in recruitment due to covid-19
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 15 Aug 2019 (actual)
- Primary completion
- 2 Mar 2020 (actual)
- Study completion
- 21 Jan 2021 (actual)
- First posted
- 19 Sep 2019 (actual)
- Results
- Posted 24 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two arms, one interventional group and one control. Interventional group receives compression wraps and standard medical care, control group only receives standard medical care
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: ACE compression wrapBilateral lower extremity ACE compression wraps in addition to standard medical care |
| Control | No intervention | –Standard medical care |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACE compression wrapBilateral lower extremity ACE compression wraps | Device | Intervention |
Primary outcome
Number of Participants With Readmission Within 30-days
Time frame: 30 days from hospital discharge
Assess rate of 30-day readmission of patients enrolled in study
Total Length of Hospital Stay
Time frame: From admission to hospital discharge, up to 30 days
Assess the length of hospitalization, controlling for variables
Days on IV Diuretic Therapy
Time frame: From admission to hospital discharge, up to 30 days
Assess the number of days from start of IV diuresis to transition to PO diuresis
6 secondary outcomes
Average Percentage of BNP Change
Time frame: From admission to hospital discharge, up to 30 days
Average Pre-discharge BNP
Time frame: From admission to hospital discharge, up to 30 days
Net Intake/Output of Fluids During Hospitalization
Time frame: From admission to hospital discharge, up to 30 days
IV Diuretic Infusion Used
Time frame: From admission to hospital discharge, up to 30 days
Average Percentage of Weight Change During Hospitalization
Time frame: From admission to hospital discharge, up to 30 days
AKI During Hospitalization
Time frame: From admission to hospital discharge, up to 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACE compression wrap in people with Heart Failure; With Decompensation, run by Henry Ford Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Readmission Within 30-days (time frame: 30 days from hospital discharge). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2022.