Evaluation of Lung Ultrasound in Acute Heart Failure

NCT03243773 | Completed DMC

• 1 other identifier: BASEC 2015-00133
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

Acute heart failure is a life threatening condition requiring rapid diagnosis and treatment. However, the differentiation between heart failure and other conditions presenting with acute dyspnea is notoriously difficult in the emergency room. Point-of-care lung ultrasound is a simple, rapid and noninvasive technique directly visualizing fluid content in the lung as evidence for acute heart failure. A number of publications showed the diagnostic utility of lung ultrasound in the diagnosis of heart failure, but many open questions remain. The goal of this study is to evaluate the diagnostic accuracy of lung ultrasound to predict a cardiac origin of dyspnea in unselected patients in the emergency room as compared to standard evaluation. Further goals are to evaluate if lung ultrasound provides additional diagnostic information as compared to clinical examination, NT-proBNP and chest X-ray, to compare the diagnostic accuracy of lung ultrasound in different patient subgroups (heart failure with preserved vs reduced ejection fraction, de novo vs decompensated chronic heart failure, age ≥75 vs \<75 years, women vs men and presence vs absence of concomitant pulmonary disease) and to compare demographics and clinical characteristics in different patient populations. 300 patients, aged ≥18 years presenting to the emergency room (ER) with acute dyspnoe as principal complaint will undergo initial clinical assessment of the likely etiology of dyspnea by the ER physician in charge. The second assessment by the same physician will include results of NT-proBNP according to predefined cutoffs. Final diagnosis ("Gold Standard") will be done by two experienced investigators after patient discharge taking into account the complete medical record except the results of lung ultrasound. Assessment of chest X-ray and lung ultrasound by investigators will be preforemd blinded regarding all other results.

Conditions

Acute Heart Failure

Outcome Measures

Primary Outcomes (1)

• Value of lung ultrasound in the diagnosis of acute heart failure

  Presence/Absence of heart failure

  at the time of inclusion into the study

Interventions

Lung ultrasound OTHER

Point-of-care ultrasound exam of both lungs in 4 predefined zones.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Unselected patients presenting with this acute dyspnea to the emergency department.

You may qualify if:

• Emergency room presentation with acute dyspnoe as principal complaint (either new or worsening in the last 48 hours) Age ≥18 years.

You may not qualify if:

• Immediately life threatening condition (cardiac arrest, ST-elevation myocardial infarction, shock, respiratory failure requiring intubation) No consent.

Sponsors & Collaborators

• Prof. Dr. Jörg Leuppi: lead

Study Sites (1)

Cantonal Hospital Baselland

Bruderholz, Basel-Landschaft, 4101, Switzerland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Standard laboratory samples for blood cell count, blood chemistry including NT-proBNP

Study Officials

• Peter Rickenbacher, MD

  Cantonal Hospital Baselland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Institutional Head

Study Record Dates

• First Submitted: August 4, 2017
• First Posted: August 9, 2017
• Study Start: March 1, 2016
• Primary Completion: September 30, 2018
• Study Completion: September 30, 2018
• Last Updated: September 19, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)