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

September 16, 2019 updated by: Hans Domanovits, Medical University of Vienna

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.

Study Overview

Status

Unknown

Conditions

Atrial Fibrillation

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

140

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

Study Director: Hans Domanovits, Prof., Emergency Department, Medical University Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 20, 2019

Primary Completion (Anticipated)

July 20, 2021

Study Completion (Anticipated)

July 20, 2021

Study Registration Dates

First Submitted

June 29, 2019

First Submitted That Met QC Criteria

July 1, 2019

First Posted (Actual)

July 2, 2019

Study Record Updates

Last Update Posted (Actual)

September 17, 2019

Last Update Submitted That Met QC Criteria

September 16, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

MUVienna 1568/2014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.