Investigating Reduction of aCute heArt Failure Readmission With Lung UltraSound-preliminary Trial

Acute Heart Failure Clinical Trial

— Pre-IcarUS  

Official title:

Investigating Reduction of aCute heArt Failure Readmission With Lung UltraSound-preliminary Trial (Pre-IcarUS)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04174794
• Other study ID #: 2019-01596
• Status: Terminated
• Start date: October 8, 2019
• Est. completion date: March 16, 2020

Study information

• Verified date: May 2020
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 43
• Est. completion date: March 16, 2020
• Est. primary completion date: March 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Acute Heart Failure
• Heart Failure

Intervention

Device:
• Lung ultrasound
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.

Locations

Country	Name	City	State
Switzerland	Geneva University Hospitals	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Day 0
Primary	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).	Day 4 to 6
Secondary	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.	Day 0
Secondary	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.	Day 4 to 6
Secondary	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.	Day 0, Day 4 to 6
Secondary	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	Day 30 post-discharge
Secondary	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	Day 60 post-discharge
Secondary	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	Day 90 post-discharge
Secondary	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	Day 180 post-discharge