Basics in Acute Shortness of Breath EvaLuation (BASEL V) Study

Active, not recruiting

• Conditions: Dyspnea

• Registration Number: NCT01831115
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

To improve the diagnostic and prognostic utility of various biomarkers, detailed patient's history, physical examinations and technical devices in patients presenting with acute dyspnea.

Detailed Description

Background: Acute heart failure is a common disease associated with high morbidity and mortality. Unfortunately, pathophysiology and optimal initial treatment are both ill defined.

Working Hypothesis:

* Improved understanding of the pathophysiology underlying heart failure might allow more cause-specific treatment to this syndrome.

* More rapid diagnosis of acute heart failure may allow to more rapidly initiate the appropriate treatment.

* Cardiac dysfunction especially in comorbid dyspneic patients is not adequately characterized and the spectrum of acute heart failure is more diverse than originally thought.

Methods: This is a large multicenter center, observational study enrolling unselected, consecutive patients with acute dyspnea presenting to the Emergency Department. Patient history, physical examination and laboratory parameters will be systematically obtained. Echocardiographic examinations will be routinely performed. Follow-up will be done at specified intervals (3, 6 and 12 months) after the initial presentation and risk predictors will be analyzed in multivariable regression models.

Expected Value of the Proposed Project: The data obtained during this project will help to further improve diagnostics and prognostics in patients with acute dyspnea and to better understand underlying pathology of cardiac dysfunction in this cohort.

Significance: The study aims are up-to-date and deal with an important health care problem in society. Conclusions drawn will significantly change care of patients with acute heart failure probably leading to a significant reduction of rehospitalization, morbidity and mortality.

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2013-04-04
• Study First Submitted QC: 2013-04-09
• Study First Posted: 2013-04-15
• Primary Completion: 2015-08
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-28
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 5452

Inclusion Criteria

• chief complaint of dyspnea (not penetrating injury or trauma related)
• subjects must be at least 18 years of age

Exclusion Criteria

• patient is unable or unwilling to give informed consent
• patient on hemodialysis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prognostic utility in patients with dyspnea	720 days	Prognostic value of various biomarkers, echocardiography data and novel technical measurements regarding rehospitalisation, cardiovascular mortality and all-cause and mortality
Diagnostic accuracy for the diagnosis of heart failure	baseline	Diagnostic of various biomarkers (such as natriuretic peptides, cardiac troponins, microRNA...), physical examination, detailed patient's history and novel technical devices.

Trial Locations

Locations (2)

University Hospital Basel; 🇨🇭 Basel, Switzerland

University Hospital Zurich; 🇨🇭 Zurich, Switzerland