Clinical trial NCT01831115: Basics in Acute Shortness of Breath EvaLuation (BASEL V) Study
Official title: Basics in Acute Shortness of Breath EvaLuation (BASEL V) Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Dyspnea
Keywords: heart failure
BNP
acute dyspnoea
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
First posted: 2013-04-15
Enrollment: 5452
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting with acute dyspnea to the emergency department.

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 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 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

Primary outcomes:
measure: Diagnostic accuracy for the diagnosis of heart failure
timeFrame: baseline
measure: Prognostic utility in patients with dyspnea
timeFrame: 360 days
measure: Prognostic utility in patients with dyspnea
timeFrame: 720 days
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
References:
citation: Breidthardt T, van Doorn WPTM, van der Linden N, Diebold M, Wussler D, Danier I, Zimmermann T, Shrestha S, Kozhuharov N, Belkin M, Porta C, Strebel I, Michou E, Gualandro DM, Nowak A, Meex SJR, Mueller C. Diurnal Variations in Natriuretic Peptide Levels: Clinical Implications for the Diagnosis of Acute Heart Failure. Circ Heart Fail. 2022 Jun;15(6):e009165. doi: 10.1161/CIRCHEARTFAILURE.121.009165. Epub 2022 Jun 7.
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citation: Wussler D, Kozhuharov N, Sabti Z, Walter J, Strebel I, Scholl L, Miro O, Rossello X, Martin-Sanchez FJ, Pocock SJ, Nowak A, Badertscher P, Twerenbold R, Wildi K, Puelacher C, du Fay de Lavallaz J, Shrestha S, Strauch O, Flores D, Nestelberger T, Boeddinghaus J, Schumacher C, Goudev A, Pfister O, Breidthardt T, Mueller C. External Validation of the MEESSI Acute Heart Failure Risk Score: A Cohort Study. Ann Intern Med. 2019 Feb 19;170(4):248-256. doi: 10.7326/M18-1967. Epub 2019 Jan 29.
citation: Badertscher P, Strebel I, Honegger U, Schaerli N, Mueller D, Puelacher C, Wagener M, Abacherli R, Walter J, Sabti Z, Sazgary L, Marbot S, du Fay de Lavallaz J, Twerenbold R, Boeddinghaus J, Nestelberger T, Kozhuharov N, Breidthardt T, Shrestha S, Flores D, Schumacher C, Wild D, Osswald S, Zellweger MJ, Mueller C, Reichlin T. Automatically computed ECG algorithm for the quantification of myocardial scar and the prediction of mortality. Clin Res Cardiol. 2018 Sep;107(9):824-835. doi: 10.1007/s00392-018-1253-z. Epub 2018 Apr 17.
citation: Breidthardt T, Moreno-Weidmann Z, Uthoff H, Sabti Z, Aeppli S, Puelacher C, Stallone F, Twerenbold R, Wildi K, Kozhuharov N, Wussler D, Flores D, Shrestha S, Badertscher P, Boeddinghaus J, Nestelberger T, Gimenez MR, Staub D, Aschwanden M, Lohrmann J, Pfister O, Osswald S, Mueller C. How accurate is clinical assessment of neck veins in the estimation of central venous pressure in acute heart failure? Insights from a prospective study. Eur J Heart Fail. 2018 Jul;20(7):1160-1162. doi: 10.1002/ejhf.1111. Epub 2018 Jan 4. No abstract available.