Heart FailureNCT04322851
B-line by Lung US in Patients With Acute Decompensated Heart Failure
An observational study of Heart Failure, run by Asan Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate that B-line detected by lung ultrasound before extubation in patients with acute decompensated heart failure can predict future risk of reintubation and clinical outcomes during admission in Korea. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure
- What is being tested?
- Lung ultrasound
- How many people
- 300 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Mar 2020to 1 Mar 2024
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects who are on mechanical ventilation due to acute heart failure
Who may be able to join
- mechanical ventilation due to acute heart failure
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul, 05505
Min Seok Kim, PhD, 02-3010-3948, guess124@gmail.com
Junho Hyun, MD, 02-3010-0055, jhhyun0609@gmail.com
About this study
Official title: Implication of B-line Estimated by Lung Ultrasound on Risk of Reintubation in Mechanically Ventilated Patients With Acute Decompensated Heart Failure
The purpose of this study is to evaluate that B-line detected by lung ultrasound before extubation in patients with acute decompensated heart failure can predict future risk of reintubation and clinical outcomes during admission in Korea.
- Conditions
- Heart Failure
- Being tested
- Lung 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.
Lung ultrasoundDiagnostic test
Lung ultrasound performed at the time of extubation to evaluate B-line in patients with mechanical ventilation due to acute decompensated heart failure
| Study group | Role | What they receive |
|---|---|---|
| B-line positive | Not described Receives: Diagnostic Test: Lung ultrasound | |
| B-line negative | Not described Receives: Diagnostic Test: Lung ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Re-intubation rate
Measured: within 72 hours from initial extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2020
- Study start1 Mar 2020
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Mar 2024 (estimated)
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 Asan Medical CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Min-Seok Kim, Asan Medical Center
- Investigators
- Minseok Kim, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04322851
- Sponsor's protocol ID
- AMC_2020_0164
- Status last verified
- Feb 2023
- First submitted
- 26 Feb 2020
- Last updated
- 2 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implication of B-line Estimated by Lung Ultrasound on Risk of Reintubation in Mechanically Ventilated Patients With Acute Decompensated Heart Failure
- ClinicalTrials.gov ID
- NCT04322851
- Acronym / sponsor ID
- AMC_2020_0164
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 26 Mar 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 that B-line detected by lung ultrasound before extubation in patients with acute decompensated heart failure can predict future risk of reintubation and clinical outcomes during admission in Korea.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B-line positive | – | Diagnostic Test: Lung ultrasound |
| B-line negative | – | Diagnostic Test: Lung ultrasound |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects who are on mechanical ventilation due to acute heart failure
Key inclusion criteria (1 listed)
- mechanical ventilation due to acute heart failure
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Lung ultrasoundLung ultrasound performed at the time of extubation to evaluate B-line in patients with mechanical ventilation due to acute decompensated heart failure | Diagnostic test | B-line negative, B-line positive |
Primary outcome
Re-intubation rate
Time frame: within 72 hours from initial extubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
- Individual participant dataSharing planned: Undecided
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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.
Minseok Kim principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Asan Medical Center at 1 site in South Korea.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 2 Feb 2023. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Minseok Kim ((82-2)-3010-3948, msk@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Re-intubation rate (time frame: within 72 hours from initial extubation). 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 2 Feb 2023.