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DyspneaBASEL VNCT01831115

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

An observational study of Dyspnea, run by University Hospital, Basel, Switzerland at 2 sites in Switzerland.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Dyspnea
How many people
5,452 participants
Where
2 sitesSwitzerland
Study dates
Apr 2006to Dec 2025
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients presenting with acute dyspnea to the emergency department.

Who may be able to join

  • chief complaint of dyspnea (not penetrating injury or trauma related)
  • subjects must be at least 18 years of age

Who cannot join

  • patient is unable or unwilling to give informed consent
  • patient on hemodialysis

Trial locations and contacts

2 sites in 1 country.

Switzerland2 sites

  • University Hospital Basel

    Basel, 4031

  • University Hospital Zurich

    Zurich, 8091

Other trials in Switzerland

About this study

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.

Read the 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.

Conditions
Dyspnea
Keywords
heart failure, BNP, acute dyspnoea
Medical subject headings
Dyspnea, Heart Failure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: baseline

  2. 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

    Measured: 360 days

  3. 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

    Measured: 720 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2013 (estimated)
  2. Study startApr 2006
  3. Primary completionAug 2015
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
5,452 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01831115
Sponsor's protocol ID
BASEL V
Acronym
BASEL V
Status last verified
Feb 2025
First submitted
4 Apr 2013
Last updated
28 Feb 2025
Results posted
No
Data monitoring committee
No

Publications

  • Belkin M, Wussler DN, Shrestha S, Lopez-Ayala P, Nowak A, Michou E, Papachristou A, Popescu C, Strebel I, Kozhuharov N, Sabti Z, Netzer I, Zimmermann T, Diebold M, Breidthardt T, Mueller C. Prognostic value of health-related quality of life in patients with acute dyspnoea: a cohort study. Swiss Med Wkly. 2025 Apr 15;155:3785. doi: 10.57187/s.3785.

    PubMed 40450733

  • Belkin M, Wussler D, Michou E, Strebel I, Kozhuharov N, Sabti Z, Nowak A, Shrestha S, Lopez-Ayala P, Prepoudis A, Stefanelli S, Schafer I, Mork C, Albus M, Danier I, Simmen C, Zimmermann T, Diebold M, Breidthardt T, Mueller C. Prognostic Value of Self-Reported Subjective Exercise Capacity in Patients With Acute Dyspnea. JACC Adv. 2023 May 26;2(3):100342. doi: 10.1016/j.jacadv.2023.100342. eCollection 2023 May.

    PubMed 38939580

  • 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.

    PubMed 35670217

  • Diebold M, Kozhuharov N, Wussler D, Strebel I, Sabti Z, Flores D, Shrestha S, Martin J, Staub D, Venge P, Mueller C, Breidthardt T. Mortality and pathophysiology of acute kidney injury according to time of occurrence in acute heart failure. ESC Heart Fail. 2020 Oct;7(5):3219-3224. doi: 10.1002/ehf2.12788. Epub 2020 Jun 24.

    PubMed 32578962

  • Wussler D, Kozhuharov N, Tavares Oliveira M, Bossa A, Sabti Z, Nowak A, Murray K, du Fay de Lavallaz J, Badertscher P, Twerenbold R, Shrestha S, Flores D, Nestelberger T, Walter J, Boeddinghaus J, Zimmermann T, Koechlin L, von Eckardstein A, Breidthardt T, Mueller C. Clinical Utility of Procalcitonin in the Diagnosis of Pneumonia. Clin Chem. 2019 Dec;65(12):1532-1542. doi: 10.1373/clinchem.2019.306787. Epub 2019 Oct 15.

    PubMed 31615771

  • 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.

    PubMed 30690646

  • 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.

    PubMed 29667014

  • 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.

    PubMed 29314487

Questions about this trial

What is this clinical trial studying?

An observational study of Dyspnea, run by University Hospital, Basel, Switzerland at 2 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diagnostic accuracy for the diagnosis of heart failure (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01831115, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.

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