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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by University Hospital, Basel, Switzerland
Sponsor:
Collaborator:
Swiss National Science Foundation
Information provided by (Responsible Party):
Christian Müller, MD, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01831115
First received: April 4, 2013
Last updated: April 9, 2013
Last verified: April 2013
  Purpose

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.


Condition
Dyspnea

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Basics in Acute Shortness of Breath EvaLuation (BASEL V) Study

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Diagnostic accuracy for the diagnosis of heart failure [ Time Frame: baseline ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Prognostic value of various biomarkers, echocardiography data and novel technical measurements regarding rehospitalisation, cardiovascular mortality and all-cause and mortality


Biospecimen Retention:   Samples Without DNA

EDTA, Plasma and Urine


Estimated Enrollment: 2000
Study Start Date: April 2006
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients presenting with acute dyspnea to the emergency department.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01831115

Contacts
Contact: Christian Mueller, Prof. muellerch@uhbs.ch
Contact: Christian Mueller, Prof. Dr. med. muellerch@uhbs.ch

Locations
Switzerland
University Hospital Basel Recruiting
Basel, Switzerland, 4031
Contact: Christian Mueller, Prof. Dr. med.         
Principal Investigator: Christian Mueller, Prof. Dr. med.         
Sub-Investigator: Michael Freese, UP         
Sub-Investigator: Bernadette Meller, MD         
Sub-Investigator: Tobias Breidthardt, MD         
Sub-Investigator: Raphael Twerenbold, MD         
Sub-Investigator: Ronny Ziller, MD         
University Hospital Zurich Recruiting
Zurich, Switzerland, 8091
Contact: Albina Nowak, MD    +41 44 255 10 54      
Principal Investigator: Albina Nowak, MD         
Sub-Investigator: Sarah Dejung, MD         
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Swiss National Science Foundation
  More Information

No publications provided

Responsible Party: Christian Müller, MD, Prof. Dr. med., University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01831115     History of Changes
Other Study ID Numbers: BASEL V
Study First Received: April 4, 2013
Last Updated: April 9, 2013
Health Authority: Switzerland: Swissmedic

Keywords provided by University Hospital, Basel, Switzerland:
heart failure
BNP
acute dyspnoea

Additional relevant MeSH terms:
Dyspnea
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014