Lung UltrasoundIMP-OUTCOMENCT05035459
B-lines-guided Heart Failure Management in Heart Failure Patients
An observational study of Lung Ultrasound and Heart Failure, run by Xiangtan Central Hospital at 1 site in China.
Trial summary
Background：About 50% of subclinical heart failure (Sub-HF) patients might have residual lung ultrasound B-lines (LUS-BL). Sub-HF is insensitive to widely used imaging examinations, like x-ray or echocardiography, but lung ultrasound (LUS) can sufficiently detect pulmonary congestion in Sub-HF patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Ultrasound, Heart Failure
- What is being tested?
- lung ultrasound
- How many people
- 320 participants
- Where
- 1 siteChina
- Study dates
- 25 Mar 2022to 25 Aug 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patient volunteered for the trial.
Who may be able to join
- Hospitalized heart failure patients with objective heart failure evidence during or before hospitalization.
- New York Heart Association (NYHA) class II, III, or IV.
- Patients with NT-proBNP level of at least 600pg/meal (or ≥400 pg/meal if they had been hospitalized for heart failure within the previous 12 months). Atrial fibrillation or atrial flutter patients with NT-proBNP level of at least 900 pg/ml, regardless of their history of HF hospitalization.
Who cannot join
- Exclusion criteria included patients with life expectancy less than 1 year due to malignancy. Patients with ARDS and pneumonia. Patients with interstitial lung disease/pulmonary fibrosis and patients on dialysis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of B-lines-guided Intensive Heart Failure Management on Outcome of Discharged Heart Failure Patients With Residual B-lines
Background：About 50% of subclinical heart failure (Sub-HF) patients might have residual lung ultrasound B-lines (LUS-BL). Sub-HF is insensitive to widely used imaging examinations, like x-ray or echocardiography, but lung ultrasound (LUS) can sufficiently detect pulmonary congestion in Sub-HF patients. Previous studies showed that residual LUS-BL is associated worse clinical outcome among patients with chronic heart failure. In this trial, we sought to evaluate the impact of LUS-BL guided intensive HF management post discharge in patients with residual LUS-BL on outcome up to 1 year after discharge.
Aim: IMP-OUTCOME is a prospective, single-center, observational cohort study, which is designed to investigate whether LUS-BL-guided intensive HF management post discharge might improve the outcome of HF patients with residual B-lines at discharge up to 1 year after discharge.
Read more
Methods and results: After receiving the standardized treatment of HF according to current guidelines, 320 HF patients with ≥ 3 B-lines (LUS-BL, assessed within 48 hours before discharge) will be divided into the conventional HF management group and the LUS-BL-guided intensive HF management group at 1:1 ratio. LUS-BL-guided intensive HF management group will receive optimized HF medication according to current guidelines and medication will be adjusted according the status of LUS-BL in addition to symptom and physical examination results during the follow-up at 2-month interval. Patient-related clinical data including sex, age, blood chemistry, imaging examination, drug utilization, and so on will be obtained and analyzed. Following discharge from the hospital, patients in the conventional HF management group will receive optimized HF medication according to current guidelines and medication will be adjusted without knowing the status of LU-BL during the follow-up at 2-month interval. LUS-BL will be assessed at 2-month interval post discharge in both groups, results will be transferred to HF nurses, who will decide to present the LUS-BL results to managing cardiologist or envelope the LUS-BL results till study end according to group assignment. Echocardiography examination will be performed at 12 months for all patients and EF, E/e', LA size and systolic pulmonary artery pressure will be assessed. The primary endpoint is the composite of re-hospitalization for worsening HF and all-cause death during follow-up. Secondary endpoints include the change in the Duke Activity Status Index (DASI) and NT-pro BNP, arrythmia and 6-minutes walk distance at each follow up, EF and B-lines changes at final follow up. Safety profile will be noted and analyzed. Primary results will be available by early 2024.
Conclusion: This trial will clarify the impact of LUS-BL guided intensive HF management on outcome for discharged patients with residual B-lines up to 1 year after discharge in the era of sodium-glucose cotransporter-2 inhibitors and angiotensin receptor blocker-neprilysin inhibitor.
- Conditions
- Lung Ultrasound, Heart Failure
- Being tested
- lung ultrasound
- Keywords
- subclinical heart failure, B-line, pulmonary congestion, outcome
- 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
Also called intensive HF management
drug adjustment based on lung ultrasound results
Lung ultrasoundDiagnostic test
Also called conventional HF management
drug adjustment independent on lung ultrasound results
| Study group | Role | What they receive |
|---|---|---|
| Conventional heart failure management group | Patients with ≥ 3 B-lines will be divided into the conventional heart failure management group and the LUS-BL-guided intensive heart failure management group at 1:1 ratio. Patients in the conventional heart failure management group will receive conventional guideline recommended HF therapy post discharge and be followed up at 2-month interval post discharge by clinical visit. LUS-BL will be assessed at 2-month interval post discharge also in this group, but results will be enveloped. Receives: Diagnostic Test: lung ultrasound | |
| LU-BL guided intensive heart failure management group | The group with ≥ 3 B-lines will be divided into the conventional heart failure management group and the LUS-BL-guided intensive heart failure management group at 1:1 ratio. Patients in the LUS-BL-guided intensive heart failure management group will receive optimized HF medication and medication will be adjusted according the status of LUS-BL during the follow-up at 2-month interval. Receives: Diagnostic Test: lung ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome consisted of readmission for worsening heart failure, or death during follow-up.
follow-up by clinical visit
Measured: The patients will be followed up for 1 year after they were discharged from the hospital.
Secondary outcomes (4)
Change the Duke Activity Status Index (DASI) score
The scale consists of 12 items covering major daily physical activities such as living, housework, walking, sexual function, and recreation, and patients are judged to be able to complete the activity content by themselves. Each entry has a different score based on the weight it takes to expend on exercise energy, with the scale summing from 0 to 58.2, with higher scores representing better physical activity status.
Measured: Baseline, 2, 4, 6, 8, 10 and 12 months post discharge
Change in NT-proBNP
pg/ml
Measured: Baseline, 2, 4, 6, 8, 10 and 12 months post discharge
Change in 6-minute walk distance values (6MWD)
walk distance (meter)
Measured: Baseline, 2, 4, 6, 8, 10 and 12 months post discharge
Change in arrythmia
ECG results will be evaluated and arrythmia will be evaluated
Measured: Baseline, 2, 4, 6, 8, 10 and 12 months post discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start25 Mar 2022
- Primary completion25 May 2023
- Study completion25 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung UltrasoundStudies of the same condition, open and under way.
- 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
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiangtan Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianping Zeng, Xiangtan Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05035459
- Sponsor's protocol ID
- XiangtanCH
- Acronym
- IMP-OUTCOME
- Status last verified
- Jun 2024
- First submitted
- 25 Aug 2021
- Last updated
- 28 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Platz E, Lewis EF, Uno H, Peck J, Pivetta E, Merz AA, Hempel D, Wilson C, Frasure SE, Jhund PS, Cheng S, Solomon SD. Detection and prognostic value of pulmonary congestion by lung ultrasound in ambulatory heart failure patients. Eur Heart J. 2016 Apr 14;37(15):1244-51. doi: 10.1093/eurheartj/ehv745. Epub 2016 Jan 26.
PubMed 26819225Zhu Y, Li N, Wu M, Peng Z, Huang H, Zhao W, Yi L, Liao M, Liu Z, Peng Y, Zhou Y, Lu J, Li G, Zeng J. Impact of B-lines-guided intensive heart failure management on outcome of discharged heart failure patients with residual B-lines. ESC Heart Fail. 2022 Aug;9(4):2713-2718. doi: 10.1002/ehf2.13988. Epub 2022 May 20.
PubMed 35595501
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of B-lines-guided Intensive Heart Failure Management on Outcome of Discharged Heart Failure Patients With Residual B-lines
- ClinicalTrials.gov ID
- NCT05035459
- Acronym / sponsor ID
- IMP-OUTCOME / XiangtanCH
- Conditions
- Lung Ultrasound, Heart Failure
- Keywords
- subclinical heart failure, B-line, pulmonary congestion, outcome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Xiangtan Central HospitalUniversity, hospital or other
- Study start
- 25 Mar 2022 (actual)
- Primary completion
- 25 May 2023 (actual)
- Study completion
- 25 Aug 2024 (estimated)
- First posted
- 5 Sep 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.
Background：About 50% of subclinical heart failure (Sub-HF) patients might have residual lung ultrasound B-lines (LUS-BL). Sub-HF is insensitive to widely used imaging examinations, like x-ray or echocardiography, but lung ultrasound (LUS) can sufficiently detect pulmonary congestion in Sub-HF patients. Previous studies showed that residual LUS-BL is associated worse clinical outcome among patients with chronic heart failure. In this trial, we sought to evaluate the impact of LUS-BL guided intensive HF management post discharge in patients with residual LUS-BL on outcome up to 1 year after discharge.
Aim: IMP-OUTCOME is a prospective, single-center, observational cohort study, which is designed to investigate whether LUS-BL-guided intensive HF management post discharge might improve the outcome of HF patients with residual B-lines at discharge up to 1 year after discharge.
Methods and results: After receiving the standardized treatment of HF according to current guidelines, 320 HF patients with ≥ 3 B-lines (LUS-BL, assessed within 48 hours before discharge) will be divided into the conventional HF management group and the LUS-BL-guided intensive HF management group at 1:1 ratio. LUS-BL-guided intensive HF management group will receive optimized HF medication according to current guidelines and medication will be adjusted according the status of LUS-BL in addition to symptom and physical examination results during the follow-up at 2-month interval. Patient-related clinical data including sex, age, blood chemistry, imaging examination, drug utilization, and so on will be obtained and analyzed. Following discharge from the hospital, patients in the conventional HF management group will receive optimized HF medication according to current guidelines and medication will be adjusted without knowing the status of LU-BL during the follow-up at 2-month interval. LUS-BL will be assessed at 2-month interval post discharge in both groups, results will be transferred to HF nurses, who will decide to present the LUS-BL results to managing cardiologist or envelope the LUS-BL results till study end according to group assignment. Echocardiography examination will be performed at 12 months for all patients and EF, E/e', LA size and systolic pulmonary artery pressure will be assessed. The primary endpoint is the composite of re-hospitalization for worsening HF and all-cause death during follow-up. Secondary endpoints include the change in the Duke Activity Status Index (DASI) and NT-pro BNP, arrythmia and 6-minutes walk distance at each follow up, EF and B-lines changes at final follow up. Safety profile will be noted and analyzed. Primary results will be available by early 2024.
Conclusion: This trial will clarify the impact of LUS-BL guided intensive HF management on outcome for discharged patients with residual B-lines up to 1 year after discharge in the era of sodium-glucose cotransporter-2 inhibitors and angiotensin receptor blocker-neprilysin inhibitor.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional heart failure management group | – | Diagnostic Test: lung ultrasoundPatients with ≥ 3 B-lines will be divided into the conventional heart failure management group and the LUS-BL-guided intensive heart failure management group at 1:1 ratio. Patients in the conventional heart failure management group will receive conventional guideline recommended HF therapy post discharge and be followed up at 2-month interval post discharge by clinical visit. LUS-BL will be assessed at 2-month interval post discharge also in this group, but results will be enveloped. |
| LU-BL guided intensive heart failure management group | – | Diagnostic Test: lung ultrasoundThe group with ≥ 3 B-lines will be divided into the conventional heart failure management group and the LUS-BL-guided intensive heart failure management group at 1:1 ratio. Patients in the LUS-BL-guided intensive heart failure management group will receive optimized HF medication and medication will be adjusted according the status of LUS-BL during the follow-up at 2-month interval. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patient volunteered for the trial.
Key inclusion criteria (3 listed)
- Hospitalized heart failure patients with objective heart failure evidence during or before hospitalization.
- New York Heart Association (NYHA) class II, III, or IV.
- Patients with NT-proBNP level of at least 600pg/meal (or ≥400 pg/meal if they had been hospitalized for heart failure within the previous 12 months). Atrial fibrillation or atrial flutter patients with NT-proBNP level of at least 900 pg/ml, regardless of their history of HF hospitalization.
Key exclusion criteria (1 listed)
- Exclusion criteria included patients with life expectancy less than 1 year due to malignancy. Patients with ARDS and pneumonia. Patients with interstitial lung disease/pulmonary fibrosis and patients on dialysis.
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 ultrasoundAlso: intensive HF managementdrug adjustment based on lung ultrasound results | Diagnostic test | Conventional heart failure management group, LU-BL guided intensive heart failure management group |
| Lung ultrasoundAlso: conventional HF managementdrug adjustment independent on lung ultrasound results | Diagnostic test | Conventional heart failure management group, LU-BL guided intensive heart failure management group |
Primary outcome
The primary outcome consisted of readmission for worsening heart failure, or death during follow-up.
Time frame: The patients will be followed up for 1 year after they were discharged from the hospital.
follow-up by clinical visit
4 secondary outcomes
Change the Duke Activity Status Index (DASI) score
Time frame: Baseline, 2, 4, 6, 8, 10 and 12 months post discharge
Change in NT-proBNP
Time frame: Baseline, 2, 4, 6, 8, 10 and 12 months post discharge
Change in 6-minute walk distance values (6MWD)
Time frame: Baseline, 2, 4, 6, 8, 10 and 12 months post discharge
Change in arrythmia
Time frame: Baseline, 2, 4, 6, 8, 10 and 12 months post discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
- Results publication: PubMed 26819225Platz E, Lewis EF, Uno H, Peck J, Pivetta E, Merz AA, Hempel D, Wilson C, Frasure SE, Jhund PS, Cheng S, Solomon SD. Detection and prognostic value of pulmonary congestion by lung ultrasound in ambulatory heart failure patients. Eur Heart J. 2016 Apr 14;37(15):1244-51. doi: 10.1093/eurheartj/ehv745. Epub 2016 Jan 26.
- Derived from this study: PubMed 35595501Zhu Y, Li N, Wu M, Peng Z, Huang H, Zhao W, Yi L, Liao M, Liu Z, Peng Y, Zhou Y, Lu J, Li G, Zeng J. Impact of B-lines-guided intensive heart failure management on outcome of discharged heart failure patients with residual B-lines. ESC Heart Fail. 2022 Aug;9(4):2713-2718. doi: 10.1002/ehf2.13988. Epub 2022 May 20.
- 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?
An observational study of Lung Ultrasound and Heart Failure, run by Xiangtan Central Hospital at 1 site in China.
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 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 28 Jun 2024. 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 China. 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?
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?
The primary outcome consisted of readmission for worsening heart failure, or death during follow-up. (time frame: The patients will be followed up for 1 year after they were discharged from the hospital.). 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 NCT05035459, which also lists 2 linked publications.
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 28 Jun 2024.