Acute Heart FailurePre-IcarUSNCT04174794
Investigating Reduction of aCute heArt Failure Readmission With Lung UltraSound-preliminary Trial
An observational study of Acute Heart Failure, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
In Switzerland 15% of discharged patients are readmitted within 30 days. Acute heart failure is the leading cause of hospital admission and one of the most frequent reasons for re-admission, mainly because of congestion-driven symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Heart Failure
- What is being tested?
- Lung ultrasound
- Type of treatment
- Medical device
- How many people
- 43 participants
- Where
- 1 siteSwitzerland
- Study dates
- 8 Oct 2019to 16 Mar 2020
- 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: A convenience sample of 90 patients admitted to from the emergency room to a general internal medicine ward of a tertiary care center with the diagnosis of acute heart failure
Who may be able to join
- Diagnosis of acute heart failure on admission chart (primary or secondary diagnosis)
- Admission from the emergency room to a general internal medicine ward
- Presentation of acute heart failure according to European Society of Cardiology :
- Presence of ≥1 symptom or sign based on admission chart review and
- Raised value of N terminal-pro-brain natriuretic peptide (>300 ng/l)
Who cannot join
- Interstitial lung disease, lung cancer or metastasis, acute respiratory distress syndrome, pulmonary contusion, previous lung surgery
- Inability or unwillingness to give consent
- Presence of oligo-anuric end stage renal disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating Reduction of aCute heArt Failure Readmission With Lung UltraSound-preliminary Trial (Pre-IcarUS)
In Switzerland 15% of discharged patients are readmitted within 30 days. Acute heart failure is the leading cause of hospital admission and one of the most frequent reasons for re-admission, mainly because of congestion-driven symptoms. Residual congestion is noted in 10%-15% of patients at discharge and is associated with an increased risk of re-admission and mortality. Lung ultrasound outperforms both chest X-ray and physical examination in detection of lung congestion. Several semiquantitative scanning protocols exist for quantifying congestion. The aim of this study is to compare for the first time two widely used lung ultrasound protocols, one exhaustive (28-points) and one simplified (8-points), in real-time settings. The focus is placed on reproducibility (expert-beginner interobserver concordance), feasibility (time consumption for images acquisition and interpretation) and performance (detection of B-lines clearing) of both scores. Semi-quantitative method is expected to have better feasibility with similar reproducibility and performance.
- Conditions
- Acute Heart Failure
- Being tested
- Lung ultrasound
- Keywords
- Acute heart failure, Lung ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung ultrasoundDevice
Also called Philips Sparq® ultrasound system; Philips AG Health Systems
The two different lung ultrasound protocols are performed initially within 48 hours of internal medicine ward admission by a pair of expert-beginner echographers. In case of admission during non-working days, the first scan can be done within 72 hours from admission. Follow-up scans are repeated 4 to 6 days later or on the day of discharge if it occurs before de fourth day. Experts and beginners execute the lund ultrasound protocols in sequence, reciprocally blinded, without accessing to clinical data files.
What is being measured
The primary outcome is the main question the study is designed to answer.
Inter-observer disagreement at admission lung ultrasound
The primary endpoint is the amount of disagreement between beginner and expert echographers at admission lung ultrasound. In order to compare protocols using different grading systems, a common 4-levels interstitial syndrome (IS) severity scale is defined. For the 28-point protocol, rating of total number of B-lines will be classified according to literature in severe (>30), moderate (16-30), mild (6-15) or no signs of IS (≤5 B-lines). For the 8-point protocol, IS is arbitrarily classified as follows: 'severe' (6-8), 'moderate' (4-5), mild (2-3) and 'no signs' (0-1 positive zones).
Measured: Day 0
Inter-observer disagreement at follow-up lung ultrasound
The amount of disagreement between beginner and expert echographers is measured at follow-up lung ultrasound. In order to compare protocols using different grading systems, a common 4-levels IS severity scale is defined. For the 28-point protocol, rating of total number of B-lines will be classified according to literature in severe (>30), moderate (16-30), mild (6-15) or no signs of IS (≤5 B-lines). For the 8-point protocol, IS is arbitrarily classified as follows: 'severe' (6-8), 'moderate' (4-5), mild (2-3) and 'no signs' (0-1 positive zones).
Measured: Day 4 to 6
Secondary outcomes (7)
Time consumption for images acquisition and interpretation at admission lung ultrasound
The time spent for images acquisition and interpretation is measured in both 28-point and 8-point protocols.
Measured: Day 0
Time consumption for images acquisition and interpretation at follow-up lung ultrasound
The time spent for images acquisition and interpretation is measured in both 28-point and 8-point protocols.
Measured: Day 4 to 6
Change in interstitial syndrome severity scale and amount of B-lines at follow-up ultrasound from baseline
The clearing of B-lines following decongestive therapy is analysed and correlated to a clinical congestion score evolution, the loss of weight, N terminal-pro-brain natriuretic peptide value decline.
Measured: Day 0, Day 4 to 6
Post-discharge readmission and mortality at 30 days
The analysis of correlation between admission, follow-up lung ultrasound IS, echographic decongestion (i.e. B-lines clearing) with readmission and mortality at 30 days post-discharge
Measured: Day 30 post-discharge
Post-discharge readmission and mortality at 60 days
The analysis of correlation between admission, follow-up lung ultrasound IS, echographic decongestion (i.e. B-lines clearing) with readmission and mortality at 60 days post-discharge
Measured: Day 60 post-discharge
Post-discharge readmission and mortality at 90 days
The analysis of correlation between admission, follow-up LUS ISSS, echographic decongestion (i.e. B-lines clearing) with readmission and mortality at 90 days post-discharge
Measured: Day 90 post-discharge
Post-discharge readmission and mortality at 180 days
The analysis of correlation between admission, follow-up lung ultrasound IS, echographic decongestion (i.e. B-lines clearing) with readmission and mortality at 180 days post-discharge
Measured: Day 180 post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study start8 Oct 2019
- Primary completion16 Mar 2020
- Study completion16 Mar 2020
Why it stopped: COVID-19 Pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Heart FailureStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe 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
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Leidi, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04174794
- Sponsor's protocol ID
- 2019-01596
- Other IDs
- 2019
- Acronym
- Pre-IcarUS
- Status last verified
- May 2020
- First submitted
- 19 Nov 2019
- Last updated
- 1 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Reduction of aCute heArt Failure Readmission With Lung UltraSound-preliminary Trial (Pre-IcarUS)
- ClinicalTrials.gov ID
- NCT04174794
- Acronym / sponsor ID
- Pre-IcarUS / 2019-01596
- Conditions
- Acute Heart Failure
- Keywords
- Acute heart failure, Lung ultrasound
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: COVID-19 Pandemic
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 8 Oct 2019 (actual)
- Primary completion
- 16 Mar 2020 (actual)
- Study completion
- 16 Mar 2020 (actual)
- First posted
- 22 Nov 2019 (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.
In Switzerland 15% of discharged patients are readmitted within 30 days. Acute heart failure is the leading cause of hospital admission and one of the most frequent reasons for re-admission, mainly because of congestion-driven symptoms. Residual congestion is noted in 10%-15% of patients at discharge and is associated with an increased risk of re-admission and mortality. Lung ultrasound outperforms both chest X-ray and physical examination in detection of lung congestion. Several semiquantitative scanning protocols exist for quantifying congestion. The aim of this study is to compare for the first time two widely used lung ultrasound protocols, one exhaustive (28-points) and one simplified (8-points), in real-time settings. The focus is placed on reproducibility (expert-beginner interobserver concordance), feasibility (time consumption for images acquisition and interpretation) and performance (detection of B-lines clearing) of both scores. Semi-quantitative method is expected to have better feasibility with similar reproducibility and performance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A convenience sample of 90 patients admitted to from the emergency room to a general internal medicine ward of a tertiary care center with the diagnosis of acute heart failure
Key inclusion criteria (5 listed)
- Diagnosis of acute heart failure on admission chart (primary or secondary diagnosis)
- Admission from the emergency room to a general internal medicine ward
- Presentation of acute heart failure according to European Society of Cardiology :
- Presence of ≥1 symptom or sign based on admission chart review and
- Raised value of N terminal-pro-brain natriuretic peptide (>300 ng/l)
Key exclusion criteria (3 listed)
- Interstitial lung disease, lung cancer or metastasis, acute respiratory distress syndrome, pulmonary contusion, previous lung surgery
- Inability or unwillingness to give consent
- Presence of oligo-anuric end stage renal disease
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: Philips Sparq® ultrasound system; Philips AG Health SystemsThe two different lung ultrasound protocols are performed initially within 48 hours of internal medicine ward admission by a pair of expert-beginner echographers. In case of admission during non-working days, the first scan can be done within 72 hours from admission. Follow-up scans are repeated 4 to 6 days later or on the day of discharge if it occurs before de fourth day. Experts and beginners execute the lund ultrasound protocols in sequence, reciprocally blinded, without accessing to clinical data files. | Device | – |
Primary outcome
Inter-observer disagreement at admission lung ultrasound
Time frame: Day 0
The primary endpoint is the amount of disagreement between beginner and expert echographers at admission lung ultrasound. In order to compare protocols using different grading systems, a common 4-levels interstitial syndrome (IS) severity scale is defined. For the 28-point protocol, rating of total number of B-lines will be classified according to literature in severe (>30), moderate (16-30), mild (6-15) or no signs of IS (≤5 B-lines). For the 8-point protocol, IS is arbitrarily classified as follows: 'severe' (6-8), 'moderate' (4-5), mild (2-3) and 'no signs' (0-1 positive zones).
Inter-observer disagreement at follow-up lung ultrasound
Time frame: Day 4 to 6
The amount of disagreement between beginner and expert echographers is measured at follow-up lung ultrasound. In order to compare protocols using different grading systems, a common 4-levels IS severity scale is defined. For the 28-point protocol, rating of total number of B-lines will be classified according to literature in severe (>30), moderate (16-30), mild (6-15) or no signs of IS (≤5 B-lines). For the 8-point protocol, IS is arbitrarily classified as follows: 'severe' (6-8), 'moderate' (4-5), mild (2-3) and 'no signs' (0-1 positive zones).
7 secondary outcomes
Time consumption for images acquisition and interpretation at admission lung ultrasound
Time frame: Day 0
Time consumption for images acquisition and interpretation at follow-up lung ultrasound
Time frame: Day 4 to 6
Change in interstitial syndrome severity scale and amount of B-lines at follow-up ultrasound from baseline
Time frame: Day 0, Day 4 to 6
Post-discharge readmission and mortality at 30 days
Time frame: Day 30 post-discharge
Post-discharge readmission and mortality at 60 days
Time frame: Day 60 post-discharge
Post-discharge readmission and mortality at 90 days
Time frame: Day 90 post-discharge
Post-discharge readmission and mortality at 180 days
Time frame: Day 180 post-discharge
Results and safety
The study was stopped early (reason given: COVID-19 Pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2020.
- 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 Acute Heart Failure, run by University Hospital, Geneva at 1 site in Switzerland.
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 3 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 1 Jun 2020. 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 Switzerland. 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 stopped early (reason given: COVID-19 Pandemic). 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?
Inter-observer disagreement at admission lung ultrasound (time frame: Day 0). The study lists 2 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 1 Jun 2020.