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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

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

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 Summary:

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 r
Sponsor: University Hospital, Basel, Switzerland

Current Primary Outcome:

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University Hospital, Basel, Switzerland

Dates:
Date Received: April 4, 2013
Date Started: April 2006
Date Completion: July 2017
Last Updated: March 3, 2016
Last Verified: March 2016