Rapid Ventricular Response Atrial FibrillationPhase 4NCT01655303
Rate Control in Atrial Fibrillation
A Phase 4 study testing Propranolol, Metoprolol and Verapamil in people with Rapid Ventricular Response Atrial Fibrillation, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
Rate control in atrial fibrillation is a usual battle in emergency departments. Oral medications have a natural superiority to intravenous ones because they are easy-to-use and decrease the workload in busy emergency departments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rapid Ventricular Response Atrial Fibrillation
- What is being tested?
- Propranolol, Metoprolol and Verapamil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteIran
- Study dates
- Feb 2011to Dec 2011
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age more than 18 years old
- Stability in hemodynamic
Who cannot join
- Systolic blood pressure less than 90 mm Hg
- Altered mental status attributable to rapid ventricular response atrial fibrillation
- Acute pulmonary edema attributable to rapid ventricular response atrial fibrillation
- Chest pain attributable to rapid ventricular response atrial fibrillation
- Allergy to Propranolol or Metoprolol or Verapamil or Diltiazem
- History of asthma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral Propranolol, Diltiazem, Metoprolol and Verapamil in Atrial Fibrillation Rate Control in Patients With Stable Hemodynamic Status
Rate control in atrial fibrillation is a usual battle in emergency departments. Oral medications have a natural superiority to intravenous ones because they are easy-to-use and decrease the workload in busy emergency departments.
This study wants to find an effective oral medication for rate control in rapid ventricular response atrial fibrillation. Propranolol and Metoprolol, Diltiazem and Verapamil are compared in patients with a stable hemodynamic status.
- Being tested
- Propranolol, Metoprolol, Verapamil, Diltiazem
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropranololDrug
Also called Inderal
MetoprololDrug
Also called Metoral
VerapamilDrug
DiltiazemDrug
| Study group | Role | What they receive |
|---|---|---|
| Metoprolol Per Oral | Experimental | 50 mg Metoprolol Receives: Drug: Metoprolol |
| Verapamil | Experimental | 40 mg Verapamil Per Oral Receives: Drug: Verapamil |
| Propranolol | Experimental | 40 mg Propranolol Per Oral Receives: Drug: Propranolol |
| Diltiazem | Experimental | 60 mg Diltiazem Per Oral Receives: Drug: Diltiazem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate less than 100 per minute
Ventricular rate less than 100 per minute after 1 hour of per oral medication administration
Measured: In 1 hour
Secondary outcomes (2)
Drugs adverse effects
Drugs adverse effects seen in patients in 2 hours after per oral medication administration
Measured: 2 hours
Unstability in hemodynamic
Hemodynamic instability (systolic blood pressure less than 90 mmHg, loss of consciousness, pulmonary edema, chest pain)
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2012 (estimated)
- Study startFeb 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rapid Ventricular Response Atrial FibrillationStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01655303
- Sponsor's protocol ID
- 16057
- Status last verified
- Jul 2012
- First submitted
- 30 Jul 2012
- Last updated
- 1 Aug 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Propranolol, Diltiazem, Metoprolol and Verapamil in Atrial Fibrillation Rate Control in Patients With Stable Hemodynamic Status
- ClinicalTrials.gov ID
- NCT01655303
- Acronym / sponsor ID
- 16057
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 1 Aug 2012 (estimated)
- 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.
Rate control in atrial fibrillation is a usual battle in emergency departments. Oral medications have a natural superiority to intravenous ones because they are easy-to-use and decrease the workload in busy emergency departments.
This study wants to find an effective oral medication for rate control in rapid ventricular response atrial fibrillation. Propranolol and Metoprolol, Diltiazem and Verapamil are compared in patients with a stable hemodynamic status.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Metoprolol Per Oral | Experimental | Drug: Metoprolol50 mg Metoprolol |
| Verapamil | Experimental | Drug: Verapamil40 mg Verapamil Per Oral |
| Propranolol | Experimental | Drug: Propranolol40 mg Propranolol Per Oral |
| Diltiazem | Experimental | Drug: Diltiazem60 mg Diltiazem Per Oral |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age more than 18 years old
- Stability in hemodynamic
Key exclusion criteria (6 listed)
- Systolic blood pressure less than 90 mm Hg
- Altered mental status attributable to rapid ventricular response atrial fibrillation
- Acute pulmonary edema attributable to rapid ventricular response atrial fibrillation
- Chest pain attributable to rapid ventricular response atrial fibrillation
- Allergy to Propranolol or Metoprolol or Verapamil or Diltiazem
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 |
|---|---|---|
| PropranololAlso: Inderal | Drug | Propranolol |
| MetoprololAlso: Metoral | Drug | Metoprolol Per Oral |
| Verapamil | Drug | Verapamil |
| Diltiazem | Drug | Diltiazem |
Primary outcome
Rate less than 100 per minute
Time frame: In 1 hour
Ventricular rate less than 100 per minute after 1 hour of per oral medication administration
2 secondary outcomes
Drugs adverse effects
Time frame: 2 hours
Unstability in hemodynamic
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Propranolol, Metoprolol and Verapamil in people with Rapid Ventricular Response Atrial Fibrillation, run by Tehran University of Medical Sciences at 1 site in Iran.
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 2 inclusion and 6 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: finished, as of the sponsor's last update on 1 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate less than 100 per minute (time frame: In 1 hour). 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 1 Aug 2012.