Blood Pressure During Rate Control in Patients With Tachy... | NCT04005482

Studies
Blood Pressure During Rate Control in Patients With Tachycardic Atrial Fibrillation at the Emergency Department

NCT04005482

Sponsor

Medical University of Vienna

Status

Unknown status

Last Update Posted

Sep 17, 2019Actual

Enrollment

140Estimated

Phase

Not provided

Conditions

Atrial Fibrillation

Interventions

Rate control

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 20, 2019Estimated

Primary Completion Date

Jul 20, 2021Estimated

Completion Date

Jul 20, 2021Estimated

First Submitted Date

Jun 29, 2019

First Submission Date that Met QC Criteria

Jul 1, 2019

First Posted Date

Jul 2, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 16, 2019

Last Update Posted Date

Sep 17, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hans Domanovits, Principal Investigator, Medical University of ViennaPrincipal Investigator

Lead Sponsor

Medical University of ViennaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

140Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rate control	Other	Rate control according to the Atrial fibrillation - ESC Guidelines 2016

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

120 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jan Niederdöckl, Dr.med.univ	Contact	0043 40400 19640		jan.niederdoeckl@meduniwien.ac.at
Filippo Cacioppo	Contact	0043 40400 19640		filippo.cacioppo@meduniwien.ac.at

Overall Officials

Name	Affiliation	Role
Hans Domanovits, Prof.	Emergency Department, Medical University Vienna	Study Director

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006339	Heart Rate

Ancestor Terms

ID	Term
D055986	Vital Signs
D010808	Physical Examination
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided