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Blood Pressure During Rate Control in Patients With Tachycardic Atrial Fibrillation at the Emergency Department (BPIRCTPTAF)

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ClinicalTrials.gov Identifier: NCT04005482
Recruitment Status : Not yet recruiting
First Posted : July 2, 2019
Last Update Posted : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
Hans Domanovits, Medical University of Vienna

Brief Summary:
The aim of this study is to analyse blood pressure during rate control therapy in patients with tachycardic atrial fibrillation in a real-world emergency cohort.

Condition or disease Intervention/treatment
Atrial Fibrillation Other: Rate control

Detailed Description:

Atrial fibrillation (AF) is the primary clinical problem in 3.3% to 10.0 % emergency department (ED) admissions. Rate control is an integral part of the management of symptomatic tachycardic AF patients.

According to the recent guidelines beta-blockers, digoxin, the calcium channel blockers diltiazem and verapamil, amiodarone or combination therapy should be considered for rate control. Haemodynamic side-effects in particular hypotension may occur. Heart rate and blood pressure behavior in an ED population during rate control therapy in patients with tachycardic atrial fibrillation will be analysed.

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Study Type : Observational
Estimated Enrollment : 140 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Blood Pressure During Rate Control in Patients With Tachycardic Atrial Fibrillation at the Emergency Department
Estimated Study Start Date : September 20, 2019
Estimated Primary Completion Date : July 20, 2021
Estimated Study Completion Date : July 20, 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Rate control
    Rate control according to the Atrial fibrillation - ESC Guidelines 2016


Primary Outcome Measures :
  1. Mean and maximum blood pressure difference between before (baseline) and during/after medication. [ Time Frame: 20th July 2019 to 20th July 2021 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
We plan to include all patients admitted to the Emergency Department of the Medical University Vienna with tachycardic AF receiving rate control therapy.
Criteria

Inclusion Criteria:

  • Age > 18 years
  • Atrial fibrillation or atrial flutter and heart rate ≥ 110 bpm
  • Indication for rate control
  • Informed consent

Exclusion Criteria:

• Inclusion criteria not met


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04005482


Contacts
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Contact: Jan Niederdöckl, Dr.med.univ 0043 40400 19640 jan.niederdoeckl@meduniwien.ac.at
Contact: Filippo Cacioppo 0043 40400 19640 filippo.cacioppo@meduniwien.ac.at

Sponsors and Collaborators
Medical University of Vienna
Investigators
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Study Director: Hans Domanovits, Prof. Emergency Department, Medical University Vienna
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Responsible Party: Hans Domanovits, Principal Investigator, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT04005482    
Other Study ID Numbers: MUVienna 1568/2014
First Posted: July 2, 2019    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Emergencies
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Disease Attributes