Atrial FibrillationBPIRCTPTAFNCT04005482
Blood Pressure During Rate Control in Patients With Tachycardic Atrial Fibrillation at the Emergency Department
An observational study of Atrial Fibrillation, run by Medical University of Vienna.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 20 Sep 2019to 20 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older 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.
Who may be able to join
- Age > 18 years
- Atrial fibrillation or atrial flutter and heart rate ≥ 110 bpm
- Indication for rate control
- Informed consent
Who cannot join
- Inclusion criteria not met
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Atrial Fibrillation
- Being tested
- Rate control
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rate controlOther
Rate control according to the Atrial fibrillation - ESC Guidelines 2016
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean and maximum blood pressure difference between before (baseline) and during/after medication.
Measured: 20th July 2019 to 20th July 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2019
- Study start20 Sep 2019 (estimated)
- Primary completion20 Jul 2021 (estimated)
- Study completion20 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hans Domanovits, Medical University of Vienna
- Investigators
- Hans Domanovits, Prof., Study director, Emergency Department, Medical University Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04005482
- Sponsor's protocol ID
- MUVienna 1568/2014
- Acronym
- BPIRCTPTAF
- Status last verified
- Sep 2019
- First submitted
- 29 Jun 2019
- Last updated
- 17 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Pressure During Rate Control in Patients With Tachycardic Atrial Fibrillation at the Emergency Department
- ClinicalTrials.gov ID
- NCT04005482
- Acronym / sponsor ID
- BPIRCTPTAF / MUVienna 1568/2014
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 20 Sep 2019 (estimated)
- Primary completion
- 20 Jul 2021 (estimated)
- Study completion
- 20 Jul 2021 (estimated)
- First posted
- 2 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (4 listed)
- Age > 18 years
- Atrial fibrillation or atrial flutter and heart rate ≥ 110 bpm
- Indication for rate control
- Informed consent
Key exclusion criteria (1 listed)
- Inclusion criteria not met
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rate controlRate control according to the Atrial fibrillation - ESC Guidelines 2016 | Other | – |
Primary outcome
Mean and maximum blood pressure difference between before (baseline) and during/after medication.
Time frame: 20th July 2019 to 20th July 2021
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2019.
- Individual participant dataSharing planned: Undecided
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans Domanovits, Prof. study director
Emergency Department, Medical University Vienna
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Medical University of Vienna.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jan Niederdöckl, Dr.med.univ (0043 40400 19640, jan.niederdoeckl@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean and maximum blood pressure difference between before (baseline) and during/after medication. (time frame: 20th July 2019 to 20th July 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2019.