DyspneaNCT02049853
The Triple A Initiative Study ("Aktionsbündnis Akute Atemnot")
A study testing NTproBNP measurement with point of care device "Cobash232" in the POCT group in people with Dyspnea and Heart Failure, run by Prof. Dr. Michael Christ at 6 sites in Germany.
Trial summary
Acute dyspnea is a common chief complaint of patients presenting to the emergency department. Patients with acute dyspnea display a high mortality rate. In-hospital mortality is as high as 10% during hospitalization and up to 30% within 6 months of follow-up. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyspnea, Heart Failure
- What is being tested?
- NTproBNP measurement with point of care device "Cobash232" in the POCT group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 6 sitesGermany
- Study dates
- Jun 2013to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- acute dyspnea (NYHA II-IV)
- age >= 18 years
- informed consent
Who cannot join
- cardiopulmonary resuscitation < 7 days
- cardiogenic shock, STEMI, respiratory failure, or other clinical conditions that require immediate intensive care admission or angioplasty
- systolic blood pressure lower than 100 mmHg at first contact/presentation
- ventricular tachycardia
- severe aortic stenosis
- advanced neoplasm (e.g. lung cancer, hematologic neoplasm, etc.)
- chronic kidney disease requiring hemodialysis
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Germany6 sites
Bayrisches Rotes Kreuz
Fürth, 90762
Klinikum Fürth, Emergency Department
Fürth, 90766
Universitätsklinikum Jena, Department of Anesthesiology and Intensive Care Medicine
Jena, 07747
DRK-Kreisverbandes Jena-Eisenberg-Stadtroda e.V.
Jena, 07749
Klinikum Nürnberg
Nuremberg, Bavaria, 90419
Johanniter-Unfall-Hilfe
Nuremberg, 90419
About this study
Official title: A Prospective Randomized Study of Coordinated Diagnostic Pathways and Treatment Algorithms for Patients With Acute Dyspnea Including Point-of-care Testing of a Cardiac Biomarker by the Emergency Medical Service Team
Acute dyspnea is a common chief complaint of patients presenting to the emergency department. Patients with acute dyspnea display a high mortality rate. In-hospital mortality is as high as 10% during hospitalization and up to 30% within 6 months of follow-up. The Triple A Initiative Study is designed to improve the coordination of care for patients with acute dyspnea alerting the Emergency Medical Service (EMS). We hypothesize that the coordination of care starting at the EMS level including point-of-care testing of the cardiac biomarker NTproBNP will support preclinical and clinical diagnostic clarification. Treatment deriving from earlier diagnostic clarification will reduce length of stay in the hospital, treatment costs and improve patient's outcome.
Read the detailed description
The aim of this prospective, randomized study is to evaluate the effects of point-of-care testing of NT-proBNP in patients presenting with acute dyspnea to the Emergency Medical Service (EMS).Patients will be enrolled in the Emergency Medical Services of participating German hospitals (Klinikum Nürnberg, Klinikum Fürth, Universitätsklinikum Jena). To be enrolled in the study, each patient must meet all of the following inclusion criteria and none of the exclusion criteria.
Patients with acute dyspnea randomized to the POCT group will get a NT-proBNP-POCT measurement in the EMS. The emergency physician of the EMS will decide to apply predefined treatment strategies according to the resulting working hypothesis. Patients with acute dyspnea randomized to the standard care group will NOT get NT-proBNP measurement at the scene. The emergency physician of the ED will construct the working hypothesis following current treatment recommendations. The major focus of the study is to initiate treatment of heart failure as early as possible.
- Conditions
- Dyspnea, Heart Failure
- Being tested
- NTproBNP measurement with point of care device "Cobash232" in the POCT group
- Keywords
- acute dyspnea, heart failure, diagnostics, POCT analysis, preclinical area
- Medical subject headings
- Dyspnea, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NTproBNP measurement with point of care device "Cobash232" in the POCT groupDevice
| Study group | Role | What they receive |
|---|---|---|
| default group | No intervention | Patients with the randomization result "default group" receive standard diagnostics |
| POCT group | Active comparator | patients with the randomization result "POCT group" receive a NTproBNP measurement with point of care device "Cobash232" in the ambulance vehicle Receives: Device: NTproBNP measurement with point of care device "Cobash232" in the POCT group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days alive and out of hospital within 30 days
Measured: 30 days
Secondary outcomes (10)
Cost-effectiveness analysis evaluating both costs and effects of alternative therapies (NT-proBNP vs. control group) at day 30, 90 and 180 days
Measured: 60 months
Diagnostic accuracy of chest ultrasound to detect patients with acute heart failure
Measured: 1 month
In-hospital length of stay during follow-up of 30 and 90 days
Measured: 3 months
Improvement of symptoms (dyspnea) 24h, 48h, 72h hours after admission
Measured: 1 month
Need for ICU admission during initial hospitalization
Measured: 6 months
B-type natriuretic peptide level and calculated glomerular filtration rate at discharge
Measured: 6 months
Patients functional status at 30, 90 and 180 days (Barthel Index)
Measured: 6 months
Mortality at 30, 90 and 180 days
Measured: 6 months
Total treatment costs at 30, 90 and 180 days
Measured: 6 months
Days alive and out of hospital at 90 and 180 days
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2014 (estimated)
- Study startJun 2013
- Primary completionApr 2015
- Study completionMay 2015
Why it stopped: recruitment numbers lower than expected
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Michael Christ
- Sponsor type
- University, hospital or other
- Collaborators
- Jena University Hospital, City Hospital Fürth, Roche Pharma AG, Bayrisches Rotes Kreuz Fuerth, Johanniter Unfall Hilfe Nürnberg, DRK-Kreisverbandes Jena-Eisenberg-Stadtroda e.V.
- Responsible party
- Sponsor-investigator, Prof. Dr. Michael Christ, Klinikum Nürnberg
- Investigators
- Michael Christ, Prof., Principal investigator, Klinikum Nürnberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02049853
- Sponsor's protocol ID
- TripleA01
- Status last verified
- May 2015
- First submitted
- 28 Jan 2014
- Last updated
- 20 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Study of Coordinated Diagnostic Pathways and Treatment Algorithms for Patients With Acute Dyspnea Including Point-of-care Testing of a Cardiac Biomarker by the Emergency Medical Service Team
- ClinicalTrials.gov ID
- NCT02049853
- Acronym / sponsor ID
- TripleA01
- Conditions
- Dyspnea, Heart Failure
- Keywords
- acute dyspnea, heart failure, diagnostics, POCT analysis, preclinical area
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment numbers lower than expected
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Prof. Dr. Michael ChristUniversity, hospital or other
- Collaborators
- Jena University Hospital, City Hospital Fürth, Roche Pharma AG, Bayrisches Rotes Kreuz Fuerth, Johanniter Unfall Hilfe Nürnberg, DRK-Kreisverbandes Jena-Eisenberg-Stadtroda e.V.
- Study start
- Jun 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 30 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acute dyspnea is a common chief complaint of patients presenting to the emergency department. Patients with acute dyspnea display a high mortality rate. In-hospital mortality is as high as 10% during hospitalization and up to 30% within 6 months of follow-up. The Triple A Initiative Study is designed to improve the coordination of care for patients with acute dyspnea alerting the Emergency Medical Service (EMS). We hypothesize that the coordination of care starting at the EMS level including point-of-care testing of the cardiac biomarker NTproBNP will support preclinical and clinical diagnostic clarification. Treatment deriving from earlier diagnostic clarification will reduce length of stay in the hospital, treatment costs and improve patient's outcome.
Detailed description
The aim of this prospective, randomized study is to evaluate the effects of point-of-care testing of NT-proBNP in patients presenting with acute dyspnea to the Emergency Medical Service (EMS).Patients will be enrolled in the Emergency Medical Services of participating German hospitals (Klinikum Nürnberg, Klinikum Fürth, Universitätsklinikum Jena). To be enrolled in the study, each patient must meet all of the following inclusion criteria and none of the exclusion criteria.
Patients with acute dyspnea randomized to the POCT group will get a NT-proBNP-POCT measurement in the EMS. The emergency physician of the EMS will decide to apply predefined treatment strategies according to the resulting working hypothesis. Patients with acute dyspnea randomized to the standard care group will NOT get NT-proBNP measurement at the scene. The emergency physician of the ED will construct the working hypothesis following current treatment recommendations. The major focus of the study is to initiate treatment of heart failure as early as possible.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| default group | No intervention | –Patients with the randomization result "default group" receive standard diagnostics |
| POCT group | Active comparator | Device: NTproBNP measurement with point of care device "Cobash232" in the POCT grouppatients with the randomization result "POCT group" receive a NTproBNP measurement with point of care device "Cobash232" in the ambulance vehicle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- acute dyspnea (NYHA II-IV)
- age >= 18 years
- informed consent
Key exclusion criteria (7 listed)
- cardiopulmonary resuscitation < 7 days
- cardiogenic shock, STEMI, respiratory failure, or other clinical conditions that require immediate intensive care admission or angioplasty
- systolic blood pressure lower than 100 mmHg at first contact/presentation
- ventricular tachycardia
- severe aortic stenosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NTproBNP measurement with point of care device "Cobash232" in the POCT group | Device | POCT group |
Primary outcome
Days alive and out of hospital within 30 days
Time frame: 30 days
10 secondary outcomes
Cost-effectiveness analysis evaluating both costs and effects of alternative therapies (NT-proBNP vs. control group) at day 30, 90 and 180 days
Time frame: 60 months
Diagnostic accuracy of chest ultrasound to detect patients with acute heart failure
Time frame: 1 month
In-hospital length of stay during follow-up of 30 and 90 days
Time frame: 3 months
Improvement of symptoms (dyspnea) 24h, 48h, 72h hours after admission
Time frame: 1 month
Need for ICU admission during initial hospitalization
Time frame: 6 months
B-type natriuretic peptide level and calculated glomerular filtration rate at discharge
Time frame: 6 months
Patients functional status at 30, 90 and 180 days (Barthel Index)
Time frame: 6 months
Mortality at 30, 90 and 180 days
Time frame: 6 months
Total treatment costs at 30, 90 and 180 days
Time frame: 6 months
Days alive and out of hospital at 90 and 180 days
Time frame: 6 months
Results and safety
The study was stopped early (reason given: recruitment numbers lower than expected). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2015.
Related trials for Dyspnea
Not yet recruiting
Mechanical Ventilator Adjustments and Patient Dyspnea
Respiratory Failure, Dyspnea During Mechanical Ventilation
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruiting
Lung Cancer and Aging: Improving Well-being for Older Adults With Lung Cancer
Lung Cancer
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
Recruiting
The Impact of Telemedicine, Using the Caller's Mobile Phone Camera, on the Quality of Care Provided to Adult Patients Contacting the 15 Centre for Acute Dyspnea
Dyspnea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Christ, Prof. principal investigator
Klinikum Nürnberg
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NTproBNP measurement with point of care device "Cobash232" in the POCT group in people with Dyspnea and Heart Failure, run by Prof. Dr. Michael Christ at 6 sites in Germany.
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 3 inclusion and 7 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: stopped early, as of the sponsor's last update on 20 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany. 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?
The study was stopped early (reason given: recruitment numbers lower than expected). Results are not available in the source record.
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?
Days alive and out of hospital within 30 days (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 May 2015.