NCT04005482

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2019

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 2, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

September 20, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2021

Completed
Last Updated

September 17, 2019

Status Verified

September 1, 2019

Enrollment Period

1.8 years

First QC Date

June 29, 2019

Last Update Submit

September 16, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mean and maximum blood pressure difference between before (baseline) and during/after medication.

    20th July 2019 to 20th July 2021

Interventions

Rate control according to the Atrial fibrillation - ESC Guidelines 2016

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Heart Rate

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vital SignsPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisHemodynamicsCardiovascular Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Hans Domanovits, Prof.

    Emergency Department, Medical University Vienna

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 29, 2019

First Posted

July 2, 2019

Study Start

September 20, 2019

Primary Completion

July 20, 2021

Study Completion

July 20, 2021

Last Updated

September 17, 2019

Record last verified: 2019-09