The Triple A Initiative Study ("Aktionsbündnis Akute Atemnot")

Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02049853
• Other study ID #: TripleA01
• Status: Terminated
• Phase: N/A
• First received: January 28, 2014
• Last updated: May 19, 2015
• Start date: June 2013
• Est. completion date: May 2015

Study information

• Verified date: May 2015
• Source: Klinikum Nürnberg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 67
• Est. completion date: May 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• acute dyspnea (NYHA II-IV)

• age >= 18 years

• informed consent

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Dyspnea
• Heart Failure

Intervention

Device:
• NTproBNP measurement with point of care device "Cobash232" in the POCT group

Locations

Country	Name	City	State
Germany	Bayrisches Rotes Kreuz	Fürth
Germany	Klinikum Fürth, Emergency Department	Fürth
Germany	DRK-Kreisverbandes Jena-Eisenberg-Stadtroda e.V.	Jena
Germany	Universitätsklinikum Jena, Department of Anesthesiology and Intensive Care Medicine	Jena
Germany	Johanniter-Unfall-Hilfe	Nuremberg
Germany	Klinikum Nürnberg	Nuremberg	Bavaria

Sponsors (7)

Lead Sponsor	Collaborator
Prof. Dr. Michael Christ	Bayrisches Rotes Kreuz Fuerth, City Hospital Fürth, DRK-Kreisverbandes Jena-Eisenberg-Stadtroda e.V., Jena University Hospital, Johanniter Unfall Hilfe Nürnberg, Roche Pharma AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Days alive and out of hospital within 30 days		30 days	No
Secondary	Cost-effectiveness analysis evaluating both costs and effects of alternative therapies (NT-proBNP vs. control group) at day 30, 90 and 180 days		60 months	No
Secondary	Diagnostic accuracy of chest ultrasound to detect patients with acute heart failure		1 month	No
Secondary	In-hospital length of stay during follow-up of 30 and 90 days		3 months	No
Secondary	Improvement of symptoms (dyspnea) 24h, 48h, 72h hours after admission		1 month	No
Secondary	Need for ICU admission during initial hospitalization		6 months	No
Secondary	B-type natriuretic peptide level and calculated glomerular filtration rate at discharge		6 months	No
Secondary	Patients functional status at 30, 90 and 180 days (Barthel Index)		6 months	No
Secondary	Mortality at 30, 90 and 180 days		6 months	No
Secondary	Total treatment costs at 30, 90 and 180 days		6 months	No
Secondary	Days alive and out of hospital at 90 and 180 days		6 months	No