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

Dyspnea Clinical Trial

— BASEL V  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01831115
• Other study ID #: BASEL V
• Status: Active, not recruiting
• Start date: April 2006
• Est. completion date: December 2022

Study information

• Verified date: April 2021
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3000
• Est. completion date: December 2022
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dyspnea

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel
Switzerland	University Hospital Zurich	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Swiss National Science Foundation

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy for the diagnosis of heart failure	Diagnostic of various biomarkers (such as natriuretic peptides, cardiac troponins, microRNA...), physical examination, detailed patient's history and novel technical devices.	baseline
Primary	Prognostic utility in patients with dyspnea	Prognostic value of various biomarkers, echocardiography data and novel technical measurements regarding rehospitalisation, cardiovascular mortality and all-cause and mortality	360 days
Primary	Prognostic utility in patients with dyspnea	Prognostic value of various biomarkers, echocardiography data and novel technical measurements regarding rehospitalisation, cardiovascular mortality and all-cause and mortality	720 days