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

April 29, 2021 updated by: Christian Müller, MD, University Hospital, Basel, Switzerland
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.

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • University Hospital Basel
      • Zurich, Switzerland, 8091
        • University Hospital Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients presenting with acute dyspnea to the emergency department.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline
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
360 days
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
720 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Collaborators

Swiss National Science Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

August 1, 2015

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

April 4, 2013

First Submitted That Met QC Criteria

April 9, 2013

First Posted (Estimate)

April 15, 2013

Study Record Updates

Last Update Posted (Actual)

April 30, 2021

Last Update Submitted That Met QC Criteria

April 29, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BASEL V

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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