NCT02060799

Brief Summary

Braunwald defines dyspnoea as an abnormally uncomfortable awareness of breathing. Breathing discomfort, and its varying degrees of severity, is the one of the most disturbing symptoms patients can experience; and it is one of the main complaints in the patients presenting to the Emergency Department (ED). Dyspnea has a variety of underlying etiologies, like cardiac, pulmonary or metabolic etiologies or a combination of them, since several diseases can cause dyspnea like for instance heart failure (HF), asthma and chronic obstructive pulmonary disease (COPD). Acute heart failure syndrome (AHFS) is collectively defined as a gradual or rapid change in heart failure (HF) signs and symptoms resulting in a need for urgent therapy. Heart failure (HF) is one of the most important causes of morbidity and mortality in the industrialized world. The prevalence of symptomatic HF is estimated to range from 0.4 to 2.0% in general European population. The incidence increases rapidly with age, and in Europe. Characteristics, clinical presentation, treatment, and outcomes of HF patients admitted to hospital have been adequately described, in Europe and in the United States. The Euro Heart Failure Survey (EHFS) I with 11 327 patients described the demographics of acutely hospitalized HF patients. The ADHERE registry has data on over 100 000 hospitalizations for AHF from the USA. In-hospital mortality was 4 and 7%, in ADHERE and EHFS I, respectively. This same sensation of breathlessness is what also drives patients with asthma and chronic obstructive pulmonary disease (COPD) to the ED. Chronic obstructive pulmonary disease (COPD) exacerbation accounts for approximately 1.5 million ED visits in the United States per year. It is the third most common cause of hospitalization, with an estimated 726 000 hospitalizations in 2000 in the USA. Previous studies have demonstrated important differences between guideline recommendations and actual management of COPD exacerbation, either in the ED or during hospitalization. The diagnosis in front of a dyspneic patient in the ED remains a challenge, because of a low sensitivity of the clinical signs associated with the aging of the population and the variety of underlying diseases. Little is known about the Epidemiology of dyspneic patients in the ED at the European level. Diagnosis, prevalence and treatment of the patients may vary among European countries.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,156

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2014

Shorter than P25 for all trials

Geographic Reach
10 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

February 9, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 12, 2014

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

December 18, 2014

Status Verified

December 1, 2014

Enrollment Period

28 days

First QC Date

February 9, 2014

Last Update Submit

December 16, 2014

Conditions

Keywords

DyspneaEmergency Service, HospitalprognosisFatal OutcomeEpidemiology

Outcome Measures

Primary Outcomes (1)

  • All cause mortality

    All cause mortality will be evaluated 30 days after ED visit.

    30 days

Secondary Outcomes (1)

  • All cause rehospitalization

    30 days

Other Outcomes (1)

  • ED visit

    30 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive patients presenting to the Emergency Department with Dyspnea as main complaint during the study period.

You may qualify if:

  • Consecutive patients presenting to the Emergency Department with Dyspnea as main complaint
  • years or older

You may not qualify if:

  • No acceptance to participate from the patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Country: Belgium

Brussels, Belgium

Location

Country: Finland

Helsinki, Finland

Location

Country: France

Paris, France

Location

Country: Germany

Nuremberg, Germany

Location

Country: Italy

Rome, Italy

Location

Country: Netherlands

Amsterdam, Netherlands

Location

Country: Romania

Cluj-Napoca, Romania

Location

Country: Spain

Santander, Spain

Location

Country: Turkey

Ankara, Turkey (Türkiye)

Location

Country: United Kingdom

Manchester, United Kingdom

Location

MeSH Terms

Conditions

DyspneaEmergencies

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Study Officials

  • Said LARIBI, MD, PhD

    Lariboisière Hospital, EuSEM

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 9, 2014

First Posted

February 12, 2014

Study Start

February 1, 2014

Primary Completion

March 1, 2014

Study Completion

November 1, 2014

Last Updated

December 18, 2014

Record last verified: 2014-12

Locations