Heart DecompensationNCT04853563
Comparison of PEEP in Acute Decompensated Heart Failure
A study testing PEEP in people with Heart Decompensation and Mechanical Ventilation Pressure High, run by Asan Medical Center at 1 site in South Korea.
Trial summary
Little is known about optimal level of positive end-expiratory pressure (PEEP) in patiens who recieved invasive mechanical ventilation for acute decompensated heart failure. We therefore sought to compare clinical outcome according to low versus high PEEP. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Heart Decompensation, Mechanical Ventilation Pressure High
- What is being tested?
- PEEP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Apr 2021to 30 Apr 2024
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject who was diagnosed with congestive heart failure and objective evidence of pulmonary congestion (pulmonary edema on simple chest radiography or positive B-line on lung ultrasonography AND elevated B-type natriuretic peptide or N-terminal pro-brain natriuretic peptide level) as a reason for invasive mechanical ventilation
- Age over 19 years old
- Subject who agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the clinical site.
Who cannot join
- Subject who are on mechanical circulatory support (ECMO, intra-aortic balloon pump, VAD) at the time of randomization
- Subject who has cardiac abnormality that requires emergent or urgent percutaneous or surgical valvular procedure
- Subject who are on vasoactive or inotropic agents at least moderate dose defined as vasoactive-inotropic score >10
- Isolated preload-dependent cardiac dysfunction (isolated right ventricular failure, right ventricular infarction, constrictive pericarditis, cardiac tamponade, severe pulmonary hypertension without LV dysfunction)
- Predominant right ventricular failure defined as following; clinical evidence of right ventricular failure by attending physician's discretion including hepatojugular reflux, Kussmaul sign, cardiac liver cirrhosis, hepato/splenomegaly, acites, thronmbocytopenia, etc.
- Subject who are not on mechanical ventilation before open heart surgery
Show all 16Show fewer
- Subject who received unwitness cardiopulmonary rescucitation (CPR) or witness CPR lasting more than 30 minutes
- Subject who was already diagnosed or is suspected to have hypertophic cardiomyopathy with significant left ventricular outflow tract (LVOT) obstruction
- Subject with intracranial hemorrahge or ischemic stroke at the time of randomization
- Subject with irreversible neurologic damage or irreversible hepatic failure
- Invasive mechanical ventilation lasting more than 24 hours preceding endotracheal intubation
- Subject with underlying chronic obstructive pulmonary disease (GOLD classification III or IV) or restrictive pulmonary disease (e.g. interstitial lung disease)
- Subject with impaired consciousness that can not perform self coughing and need suction to maintain adequate airway patency
- Pregnant and/or lactating women
- Subject with life expectancy less than a year
- Subject who is not suitable to enrollment by investigator's discretion
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
About this study
Official title: Comparison of High VErsus Low Positive End-Expiratory Pressure in Mechanically Ventilated Patients With Acute Heart Failure (HELP-AFH) : Open-label Randomized Controlled Multi-center Pilot Study
Little is known about optimal level of positive end-expiratory pressure (PEEP) in patiens who recieved invasive mechanical ventilation for acute decompensated heart failure. We therefore sought to compare clinical outcome according to low versus high PEEP.
- Being tested
- PEEP
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEPOther
High PEEP targeted to 10 cmH2O to be maintained during the period of mechanical ventilation compared with low PEEP maintaining 3-5 cmH2O
| Study group | Role | What they receive |
|---|---|---|
| High PEEP | Experimental | Immediate after initiation of invasive mechanical ventilation and randomization, the PEEP level is set to be at 8 centimetre of water with an inspired oxygen fraction (FiO2) between 0.21 and 0.6. Thereafter, the PEEP level is adjusted to 1 centimetre of water higher to a minimum PEEP level of 10 with every 30 minutes. Receives: Other: PEEP |
| Low PEEP | Active comparator | Immediate after initiation of invasive mechanical ventilation and randomization, the PEEP level is set to be at 5 centimetre of water with an inspired oxygen fraction (FiO2) between 0.21 and 0.6. In this arm, the PEEP level is adjusted to 1 centimetre of water lower to a minimum PEEP level of 3 with every 30 minutes while maintaining a partial pressure of arterial blood oxygen above 65 millimeter of mercury or oxygen saturation >92% with pulse oxymetry. Receives: Other: PEEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilator-free day at 28-day
Starting at the day of randomization, and the days on non-invasive ventilation do not count. Successful extubation is defined as at least 24 hours wihtout reintubation independent of invasive assisted ventilation in survivor. Non-survivor within 28 days: ventilator-free day counted as 0, ventilator-free day among only survivor at 28-day will be counted for primary endpoint.
Measured: up to 28-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start20 Apr 2021
- Primary completion30 Jul 2023 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart DecompensationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Min-Seok Kim, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04853563
- Sponsor's protocol ID
- AMC_2021_0433
- Status last verified
- Feb 2022
- First submitted
- 20 Apr 2021
- Last updated
- 23 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hyun J, Kim IC, Kim AR, Lee HJ, Lee SE, Yun SC, Kim MS. Comparison of High Versus Low Positive End-Expiratory Pressure in Mechanically Ventilated Patients With Acute Heart Failure: Rationale and Design of the HELP-AHF Trial. Int J Heart Fail. 2025 Apr 23;7(2):79-84. doi: 10.36628/ijhf.2025.0014. eCollection 2025 Apr.
PubMed 40519712
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of High VErsus Low Positive End-Expiratory Pressure in Mechanically Ventilated Patients With Acute Heart Failure (HELP-AFH) : Open-label Randomized Controlled Multi-center Pilot Study
- ClinicalTrials.gov ID
- NCT04853563
- Acronym / sponsor ID
- AMC_2021_0433
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 30 Jul 2023 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 21 Apr 2021 (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.
Little is known about optimal level of positive end-expiratory pressure (PEEP) in patiens who recieved invasive mechanical ventilation for acute decompensated heart failure. We therefore sought to compare clinical outcome according to low versus high PEEP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High PEEP | Experimental | Other: PEEPImmediate after initiation of invasive mechanical ventilation and randomization, the PEEP level is set to be at 8 centimetre of water with an inspired oxygen fraction (FiO2) between 0.21 and 0.6. Thereafter, the PEEP level is adjusted to 1 centimetre of water higher to a minimum PEEP level of 10 with every 30 minutes. |
| Low PEEP | Active comparator | Other: PEEPImmediate after initiation of invasive mechanical ventilation and randomization, the PEEP level is set to be at 5 centimetre of water with an inspired oxygen fraction (FiO2) between 0.21 and 0.6. In this arm, the PEEP level is adjusted to 1 centimetre of water lower to a minimum PEEP level of 3 with every 30 minutes while maintaining a partial pressure of arterial blood oxygen above 65 millimeter of mercury or oxygen saturation >92% with pulse oxymetry. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject who was diagnosed with congestive heart failure and objective evidence of pulmonary congestion (pulmonary edema on simple chest radiography or positive B-line on lung ultrasonography AND elevated B-type natriuretic peptide or N-terminal pro-brain natriuretic peptide level) as a reason for invasive mechanical ventilation
- Age over 19 years old
- Subject who agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the clinical site.
Key exclusion criteria (16 listed)
- Subject who are on mechanical circulatory support (ECMO, intra-aortic balloon pump, VAD) at the time of randomization
- Subject who has cardiac abnormality that requires emergent or urgent percutaneous or surgical valvular procedure
- Subject who are on vasoactive or inotropic agents at least moderate dose defined as vasoactive-inotropic score >10
- Isolated preload-dependent cardiac dysfunction (isolated right ventricular failure, right ventricular infarction, constrictive pericarditis, cardiac tamponade, severe pulmonary hypertension without LV dysfunction)
- Predominant right ventricular failure defined as following; clinical evidence of right ventricular failure by attending physician's discretion including hepatojugular reflux, Kussmaul sign, cardiac liver cirrhosis, hepato/splenomegaly, acites, thronmbocytopenia, etc.
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 |
|---|---|---|
| PEEPHigh PEEP targeted to 10 cmH2O to be maintained during the period of mechanical ventilation compared with low PEEP maintaining 3-5 cmH2O | Other | High PEEP, Low PEEP |
Primary outcome
Ventilator-free day at 28-day
Time frame: up to 28-day
Starting at the day of randomization, and the days on non-invasive ventilation do not count. Successful extubation is defined as at least 24 hours wihtout reintubation independent of invasive assisted ventilation in survivor. Non-survivor within 28 days: ventilator-free day counted as 0, ventilator-free day among only survivor at 28-day will be counted for primary endpoint.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2022.
- Derived from this study: PubMed 40519712Hyun J, Kim IC, Kim AR, Lee HJ, Lee SE, Yun SC, Kim MS. Comparison of High Versus Low Positive End-Expiratory Pressure in Mechanically Ventilated Patients With Acute Heart Failure: Rationale and Design of the HELP-AHF Trial. Int J Heart Fail. 2025 Apr 23;7(2):79-84. doi: 10.36628/ijhf.2025.0014. eCollection 2025 Apr.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEEP in people with Heart Decompensation and Mechanical Ventilation Pressure High, 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 3 inclusion and 16 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 23 Feb 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 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?
Ventilator-free day at 28-day (time frame: up to 28-day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04853563, which also lists 1 linked publication.
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 23 Feb 2022.