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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01831115
Other study ID # BASEL V
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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