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Blood Pressure During Rate Control in Patients With Tachycardic Atrial Fibrillation at the Emergency Department (BPIRCTPTAF)
| Condition or disease | Intervention/treatment |
|---|---|
| Atrial Fibrillation | Other: Rate control |
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 |
| 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 |
- Mean and maximum blood pressure difference between before (baseline) and during/after medication. [ Time Frame: 20th July 2019 to 20th July 2021 ]
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | June 29, 2019 | ||||||||
| First Posted Date | July 2, 2019 | ||||||||
| Last Update Posted Date | September 17, 2019 | ||||||||
| Estimated Study Start Date | September 20, 2019 | ||||||||
| Estimated Primary Completion Date | July 20, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
Mean and maximum blood pressure difference between before (baseline) and during/after medication. [ Time Frame: 20th July 2019 to 20th July 2021 ] | ||||||||
| Original Primary Outcome Measures |
Mean and maximum blood pressure difference before and after medication. [ Time Frame: 10th July 2019 to 10th July 2021 ] | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures | Not Provided | ||||||||
| Original Secondary Outcome Measures | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Blood Pressure During Rate Control in Patients With Tachycardic Atrial Fibrillation at the Emergency Department | ||||||||
| Official Title | Blood Pressure During Rate Control in Patients With Tachycardic Atrial Fibrillation at the Emergency Department | ||||||||
| 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. |
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| Study Type | Observational | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| 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. | ||||||||
| Condition | Atrial Fibrillation | ||||||||
| Intervention | Other: Rate control
Rate control according to the Atrial fibrillation - ESC Guidelines 2016
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| Study Groups/Cohorts | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Not yet recruiting | ||||||||
| Estimated Enrollment |
140 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | July 20, 2021 | ||||||||
| Estimated Primary Completion Date | July 20, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria: • Inclusion criteria not met |
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| Sex/Gender |
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| Ages | 18 Years to 120 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| Listed Location Countries | Not Provided | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT04005482 | ||||||||
| Other Study ID Numbers | MUVienna 1568/2014 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Hans Domanovits, Medical University of Vienna | ||||||||
| Study Sponsor | Medical University of Vienna | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators |
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| PRS Account | Medical University of Vienna | ||||||||
| Verification Date | September 2019 | ||||||||
