Heart FailureUSA-HFNCT04376424
Ultra-sound Assisted Management of Heart Failure
A study testing Hand Held Ultrasound in people with Heart Failure, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the impact of using hand carried ultrasound measurements of volume status in directing treatment of heart failure patients admitted with acute exacerbation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- Hand Held Ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2021to 17 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- New admission from emergency department to heart failure ( red team) service for acute exacerbation of heart failure ( defined based on clinical and imaging characteristics , shortness of breath due to volume overload, CXR showing pulmonary vascular congestion/pulmonary edema, elevated NTproBNP, dyspnea Not secondary to infectious process (pneumonia).
- Heart failure NYHA class III, IV
- Age>=18 years old
Who cannot join
- End stage Renal disease on dialyses (ESRD on HD) or stage V CKD (defined as GFR<15)
- end stage Heart failure on chronic inotrope (example Milrinone)
- Renal failure that deemed to be secondary to other reason (dehydration, renal or post renal (obstructive)
- morbid obesity BMI > 40
- incarcerated patients (prison) TDC.
- pregnant patients
- Patients with dyspnea not mainly due to heart failure, ESRD patients, intubated patients
- Aged less than 18 years.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Medical Branch
Galveston, Texas, 77555
About this study
Official title: Hand Carried Ultra-Sound Assisted Medical Management of Acute Decompensated Heart Failure. A Randomized Controlled Trial (USA-HF)
The purpose of this study is to evaluate the impact of using hand carried ultrasound measurements of volume status in directing treatment of heart failure patients admitted with acute exacerbation.
Read the detailed description
The purpose of this study is to evaluate the impact of using hand carried ultrasound measurements of volume status in directing treatment of heart failure patients admitted with acute exacerbation. The use of hand carried ultrasound is expected to reduce hospital Length of stay, heart failure re-admission rates, emergency room visits and in hospital complications such as renal failure. The hypothesis tested is as follows:
Null: The use of hand carried ultrasound in the management of heart failure patients did not change outcome.
Alternative: The use of hand carried ultrasound in the management of heart failure patients did change outcome.
The study endpoints are as follows:
- A primary endpoint will be the impact of using hand carried ultrasound on length of hospital stay.
- The secondary endpoint will be 30 days re-admission following heart failure hospitalization, emergency room visits and in hospital complications such as renal failure.
This is a randomized controlled un-blinded study that poses very minimal risk because patients will only undergo an ultrasound measurement of Inferior vein cava (IVC) and internal jugular vein diameter and compressibility. Also, the society will benefit greatly with the prospect of reducing hospitalization and medical complications, optimizing healthcare delivery to heart failure patients, and reducing hospitalization cost. The results of this study/study procedure will only direct medical therapy that heart failure patients usually receive through routine care such as dose and frequency of diuresis.
- Conditions
- Heart Failure
- Being tested
- Hand Held Ultrasound
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand Held UltrasoundDiagnostic test
Guideline directed medical therapy for heart failure with the addition of hand held ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Ultra Sound Guided Therapy Group | Experimental | Hand carried ultrasound will be used in this group to measure IVCd, collapsibility along with internal jugular vein collapsibility. The results of the ultrasound will be unblinded to the treating team. Receives: Diagnostic Test: Hand Held Ultrasound |
| Conventional Therapy Group | No intervention | Conventional therapy will occur the use of hand carried ultrasound. The results will be blinded to the treating team. The managing team will analyze the data at the end of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
length of hospital stay (days)
number of days from admission to discharge
Measured: Immediately after discharge
Secondary outcomes (6)
Number of participants readmitted for heart failure with 30 days of discharge, and percentage of participant out of all participants in each group readmitted in each group within 30 days
Follow up telephone call after discharge
Measured: One month after discharge
number of participant readmitted for any reason within 30 days of discharge, and percentage of participant ( out of all participant in each group) readmitted in each group within 30 days of discharge.
assessment of readmission to hospital
Measured: One month after original discharge
percent change in GFR
amount of change in GFR
Measured: One month after original discharge
hospitalization Cost
hospitalization cost measured for all hospitalization stay from admission to discharge for each participant
Measured: immediately after discharge of hospitalization
Time to readmission
time between original hospitalization and readmission
Measured: assessed within 4 weeks from index admission (i.e. thirty days readmission)
Number of right heart catheterization in each group and percentage of right heart catheterization in each group
document what procedures were done
Measured: One month after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study startNov 2021 (estimated)
- Primary completionNov 2021 (estimated)
- Study completion17 Nov 2021
Why it stopped: No data has been collected, no subjects enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe 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
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wissam Khalife, MD, Principal investigator, University of Texas Medical Branch Galveston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04376424
- Sponsor's protocol ID
- 19-0276
- Acronym
- USA-HF
- Status last verified
- Jul 2021
- First submitted
- 14 Apr 2020
- Last updated
- 30 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hand Carried Ultra-Sound Assisted Medical Management of Acute Decompensated Heart Failure. A Randomized Controlled Trial (USA-HF)
- ClinicalTrials.gov ID
- NCT04376424
- Acronym / sponsor ID
- USA-HF / 19-0276
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No data has been collected, no subjects enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- Nov 2021 (estimated)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- 17 Nov 2021 (actual)
- First posted
- 6 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the impact of using hand carried ultrasound measurements of volume status in directing treatment of heart failure patients admitted with acute exacerbation.
Detailed description
The purpose of this study is to evaluate the impact of using hand carried ultrasound measurements of volume status in directing treatment of heart failure patients admitted with acute exacerbation. The use of hand carried ultrasound is expected to reduce hospital Length of stay, heart failure re-admission rates, emergency room visits and in hospital complications such as renal failure. The hypothesis tested is as follows:
Null: The use of hand carried ultrasound in the management of heart failure patients did not change outcome.
Alternative: The use of hand carried ultrasound in the management of heart failure patients did change outcome.
The study endpoints are as follows:
- A primary endpoint will be the impact of using hand carried ultrasound on length of hospital stay.
- The secondary endpoint will be 30 days re-admission following heart failure hospitalization, emergency room visits and in hospital complications such as renal failure.
This is a randomized controlled un-blinded study that poses very minimal risk because patients will only undergo an ultrasound measurement of Inferior vein cava (IVC) and internal jugular vein diameter and compressibility. Also, the society will benefit greatly with the prospect of reducing hospitalization and medical complications, optimizing healthcare delivery to heart failure patients, and reducing hospitalization cost. The results of this study/study procedure will only direct medical therapy that heart failure patients usually receive through routine care such as dose and frequency of diuresis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultra Sound Guided Therapy Group | Experimental | Diagnostic Test: Hand Held UltrasoundHand carried ultrasound will be used in this group to measure IVCd, collapsibility along with internal jugular vein collapsibility. The results of the ultrasound will be unblinded to the treating team. |
| Conventional Therapy Group | No intervention | –Conventional therapy will occur the use of hand carried ultrasound. The results will be blinded to the treating team. The managing team will analyze the data at the end of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- New admission from emergency department to heart failure ( red team) service for acute exacerbation of heart failure ( defined based on clinical and imaging characteristics , shortness of breath due to volume overload, CXR showing pulmonary vascular congestion/pulmonary edema, elevated NTproBNP, dyspnea Not secondary to infectious process (pneumonia).
- Heart failure NYHA class III, IV
- Age>=18 years old
Key exclusion criteria (8 listed)
- End stage Renal disease on dialyses (ESRD on HD) or stage V CKD (defined as GFR<15)
- end stage Heart failure on chronic inotrope (example Milrinone)
- Renal failure that deemed to be secondary to other reason (dehydration, renal or post renal (obstructive)
- morbid obesity BMI > 40
- incarcerated patients (prison) TDC.
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 |
|---|---|---|
| Hand Held UltrasoundGuideline directed medical therapy for heart failure with the addition of hand held ultrasound | Diagnostic test | Ultra Sound Guided Therapy Group |
Primary outcome
length of hospital stay (days)
Time frame: Immediately after discharge
number of days from admission to discharge
6 secondary outcomes
Number of participants readmitted for heart failure with 30 days of discharge, and percentage of participant out of all participants in each group readmitted in each group within 30 days
Time frame: One month after discharge
number of participant readmitted for any reason within 30 days of discharge, and percentage of participant ( out of all participant in each group) readmitted in each group within 30 days of discharge.
Time frame: One month after original discharge
percent change in GFR
Time frame: One month after original discharge
hospitalization Cost
Time frame: immediately after discharge of hospitalization
Time to readmission
Time frame: assessed within 4 weeks from index admission (i.e. thirty days readmission)
Number of right heart catheterization in each group and percentage of right heart catheterization in each group
Time frame: One month after admission
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2021.
- 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.
Wissam Khalife, MD principal investigator
University of Texas Medical Branch Galveston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hand Held Ultrasound in people with Heart Failure, run by The University of Texas Medical Branch, Galveston 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 3 inclusion and 8 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: withdrawn, as of the sponsor's last update on 30 Nov 2021. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
length of hospital stay (days) (time frame: Immediately after discharge). 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 30 Nov 2021.