Atrial FibrillationNCT02938260
Diltiazem vs. Metoprolol in the Acute Management of AF in Patients With HFrEF
An observational study of Atrial Fibrillation and Heart Failure, run by RaeAnn Hirschy.
Trial summary
Atrial fibrillation (AF) is the most common arrhythmia, accounting for one third of all hospital admissions and 1% of all emergency department visits (ED). Approximately 65% of those presenting to the ED with AF are admitted. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Heart Failure
- What is being tested?
- Metoprolol vs Diltiazem
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Mar 2017
- 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 years and older
- All sexes
- Adult, Older adult
Study population: To compare the achievement of a goal heart rate of <100 bpm or a HR reduction of at least 20% in patients with HFrEF receiving intravenous diltiazem versus intravenous metoprolol for rate control of AF with RVR.
Who may be able to join
- Non-pregnant adults ≥18 years of age with AF RVR (HR >120 bpm), which will be obtained from vital signs or electrocardiogram, in the emergency department, who have an EF <40% from an echocardiogram within the previous 4 years, and are treated with IV push metoprolol or diltiazem as first line for rate control of AF with RVR. Patients can receive up to two IV push doses but cannot switch treatment medication between these two doses.
Who cannot join
- Patients with a SBP <90 mmHg or decompensated heart failure (ie those presenting primarily with worsening of heart failure signs and symptoms, including dyspnea and lower extremity edema). Patients who are admitted multiple times within the time frame or have multiple episodes will be excluded except for the first episode within the first admission.
About this study
Official title: Diltiazem vs. Metoprolol in the Acute Management of Atrial Fibrillation in Patients With Heart Failure With Reduced Ejection Fraction
Atrial fibrillation (AF) is the most common arrhythmia, accounting for one third of all hospital admissions and 1% of all emergency department visits (ED). Approximately 65% of those presenting to the ED with AF are admitted. There are also numerous reasons for patients to get AF with rapid ventricular rate (AF RVR) during hospitalization. In the acute setting these patients are often treated with diltiazem, a non-dihydropyridine calcium channel blocker (ND CCB), or metoprolol, a beta blocker (BB). Non-dihydropyridine calcium channel blocker (diltiazem and verapamil) use is considered harmful and national guidelines recommend against use in patients with decompensated heart failure (HF). This recommendation is based on studies with long-term treatment. The purpose of this study is to assess the difference between metoprolol and diltiazem for the acute treatment of AF RVR in patients with HF with reduced ejection fraction (HFrEF).
Read the detailed description
AF and HF are frequently seen in the hospital setting. AF affects over 2 million people in the United States, while HF affects over 5 million. These disease states have a significant morbidity and mortality impact with AF leading to a 4 fold increase in stroke and 2 fold increase in death, while 50% of patients with a new HF diagnosis will die within 5 years. These two disease states share several common risk factors including, age, hypertension, diabetes mellitus, and heart disease. Based on this relationship and the changes in myocardial structure, function, and conduction the two are also risk factors for one another. Of patients with HF, 61.5% of men and 73% of women develop AF. Of those with AF, 73% of men and 75.6% of women develop HF.
Both the AF guidelines by the American Heart Association, American College of Cardiology, and Heart Rhythm Society and the HF guidelines by the American College of Cardiology Foundation and the American Heart Association recommend against the use of ND CCB in patients with HFrEF. The HF guidelines specify to avoid ND CCB in patients with reduced LVEF, but also mention avoiding most calcium channel blockers in general with the possible exception of amlodipine, due to known adverse effects and potential for harm. However, short term use of diltiazem for the acute control of RVR in patients with HFrEF has not been clearly evaluated. Three studies compare the use of BB and ND CCB in the acute treatment of AF RVR. These studies excluded those with severe (New York Heart Association Class IV) or decompensated HF, however, they did not comment on patients with compensated HFrEF. Most of these studies illustrate no difference, but the most recent study reported a success rate (heart rate (HR) <100 bpm within 30 minutes) of 95.8% with intravenous (IV) diltiazem and 46.4% with IV metoprolol (p<0.0001).
When comparing use of long term and short term therapy in patients with HFrEF a different perspective emerges. Both BB and ND CCB have negative inotropic effects which can be harmful during an acute HF exacerbation and worsen symptoms. However, BB are routinely recommended for chronic use in HFrEF due to their added neurohormonal benefit, which over time delays HF progression and reduces mortality. In contrast, long term treatment with ND CCB in those with pulmonary congestion is associated with an increased cumulative rate of cardiac events (hazard ratio 1.41). The comparative short term benefit in patients is still unclear. In a small study, patients with AF RVR and severe HF, 97% treated with IV diltiazem had a HR reduction of >20% and no evidence of HF exacerbation. A second study of patients in decompensated HF compared the use of IV metoprolol and diltiazem for control of AF RVR. Both agents were equally effective at controlling heart rate with no difference in safety endpoint or evidence of worsening heart failure. Neither of these studies specifically address compensated HFrEF.
Current literature focuses on the risks associated with ND CCB and patients with HFrEF, but these effects are with long-term treatment. Studies in the acute setting often exclude those with severe or decompensated HFrEF. Therefore, a study focusing on metoprolol versus diltiazem for the acute control of AF RVR in patients with HFrEF could offer an insight into current clinical practice.
- Conditions
- Atrial Fibrillation, Heart Failure
- Being tested
- Metoprolol vs Diltiazem
- Medical subject headings
- Atrial Fibrillation, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metoprolol vs DiltiazemDrug
| Study group | Role | What they receive |
|---|---|---|
| Diltiazem | Not described Receives: Drug: Metoprolol vs Diltiazem | |
| Metoprolol | Not described Receives: Drug: Metoprolol vs Diltiazem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful rate control
Successful rate control within 30 minutes from the first dose (HR <100 bpm or a decrease by at least 20%).
Measured: 30 minutes
Secondary outcomes (6)
Successful rate control within 15 minutes
Successful rate control within 15 minutes
Measured: 15 minutes
Successful rate control within 60 minutes
Successful rate control within 60 minutes
Measured: 60 minutes
Bradycardia
HR <60 bpm
Measured: 30 minutes
Hypotension
SBP <90 mmHg
Measured: 30 minutes
Conversion
conversion to sinus rhythm
Measured: 30 minutes
Worsening heart failure symptoms
new inotropic support, new pulmonary edema, or increased O2 requirement within 48 hr or readmission within 7 days of discharge
Measured: 48hr/readmission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionMar 2017
- Study completionMar 2017
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.
- 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
- Retrospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- RaeAnn Hirschy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, RaeAnn Hirschy, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02938260
- Sponsor's protocol ID
- 16090607
- Status last verified
- Sep 2018
- First submitted
- 17 Oct 2016
- Last updated
- 20 Sep 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diltiazem vs. Metoprolol in the Acute Management of Atrial Fibrillation in Patients With Heart Failure With Reduced Ejection Fraction
- ClinicalTrials.gov ID
- NCT02938260
- Acronym / sponsor ID
- 16090607
- Conditions
- Atrial Fibrillation, Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- RaeAnn HirschyUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 19 Oct 2016 (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.
Atrial fibrillation (AF) is the most common arrhythmia, accounting for one third of all hospital admissions and 1% of all emergency department visits (ED). Approximately 65% of those presenting to the ED with AF are admitted. There are also numerous reasons for patients to get AF with rapid ventricular rate (AF RVR) during hospitalization. In the acute setting these patients are often treated with diltiazem, a non-dihydropyridine calcium channel blocker (ND CCB), or metoprolol, a beta blocker (BB). Non-dihydropyridine calcium channel blocker (diltiazem and verapamil) use is considered harmful and national guidelines recommend against use in patients with decompensated heart failure (HF). This recommendation is based on studies with long-term treatment. The purpose of this study is to assess the difference between metoprolol and diltiazem for the acute treatment of AF RVR in patients with HF with reduced ejection fraction (HFrEF).
Detailed description
AF and HF are frequently seen in the hospital setting. AF affects over 2 million people in the United States, while HF affects over 5 million. These disease states have a significant morbidity and mortality impact with AF leading to a 4 fold increase in stroke and 2 fold increase in death, while 50% of patients with a new HF diagnosis will die within 5 years. These two disease states share several common risk factors including, age, hypertension, diabetes mellitus, and heart disease. Based on this relationship and the changes in myocardial structure, function, and conduction the two are also risk factors for one another. Of patients with HF, 61.5% of men and 73% of women develop AF. Of those with AF, 73% of men and 75.6% of women develop HF.
Both the AF guidelines by the American Heart Association, American College of Cardiology, and Heart Rhythm Society and the HF guidelines by the American College of Cardiology Foundation and the American Heart Association recommend against the use of ND CCB in patients with HFrEF. The HF guidelines specify to avoid ND CCB in patients with reduced LVEF, but also mention avoiding most calcium channel blockers in general with the possible exception of amlodipine, due to known adverse effects and potential for harm. However, short term use of diltiazem for the acute control of RVR in patients with HFrEF has not been clearly evaluated. Three studies compare the use of BB and ND CCB in the acute treatment of AF RVR. These studies excluded those with severe (New York Heart Association Class IV) or decompensated HF, however, they did not comment on patients with compensated HFrEF. Most of these studies illustrate no difference, but the most recent study reported a success rate (heart rate (HR) <100 bpm within 30 minutes) of 95.8% with intravenous (IV) diltiazem and 46.4% with IV metoprolol (p<0.0001).
When comparing use of long term and short term therapy in patients with HFrEF a different perspective emerges. Both BB and ND CCB have negative inotropic effects which can be harmful during an acute HF exacerbation and worsen symptoms. However, BB are routinely recommended for chronic use in HFrEF due to their added neurohormonal benefit, which over time delays HF progression and reduces mortality. In contrast, long term treatment with ND CCB in those with pulmonary congestion is associated with an increased cumulative rate of cardiac events (hazard ratio 1.41). The comparative short term benefit in patients is still unclear. In a small study, patients with AF RVR and severe HF, 97% treated with IV diltiazem had a HR reduction of >20% and no evidence of HF exacerbation. A second study of patients in decompensated HF compared the use of IV metoprolol and diltiazem for control of AF RVR. Both agents were equally effective at controlling heart rate with no difference in safety endpoint or evidence of worsening heart failure. Neither of these studies specifically address compensated HFrEF.
Current literature focuses on the risks associated with ND CCB and patients with HFrEF, but these effects are with long-term treatment. Studies in the acute setting often exclude those with severe or decompensated HFrEF. Therefore, a study focusing on metoprolol versus diltiazem for the acute control of AF RVR in patients with HFrEF could offer an insight into current clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diltiazem | – | Drug: Metoprolol vs Diltiazem |
| Metoprolol | – | Drug: Metoprolol vs Diltiazem |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- To compare the achievement of a goal heart rate of <100 bpm or a HR reduction of at least 20% in patients with HFrEF receiving intravenous diltiazem versus intravenous metoprolol for rate control of AF with RVR.
Key inclusion criteria (1 listed)
- Non-pregnant adults ≥18 years of age with AF RVR (HR >120 bpm), which will be obtained from vital signs or electrocardiogram, in the emergency department, who have an EF <40% from an echocardiogram within the previous 4 years, and are treated with IV push metoprolol or diltiazem as first line for rate control of AF with RVR. Patients can receive up to two IV push doses but cannot switch treatment medication between these two doses.
Key exclusion criteria (1 listed)
- Patients with a SBP <90 mmHg or decompensated heart failure (ie those presenting primarily with worsening of heart failure signs and symptoms, including dyspnea and lower extremity edema). Patients who are admitted multiple times within the time frame or have multiple episodes will be excluded except for the first episode within the first admission.
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 |
|---|---|---|
| Metoprolol vs Diltiazem | Drug | Diltiazem, Metoprolol |
Primary outcome
Successful rate control
Time frame: 30 minutes
Successful rate control within 30 minutes from the first dose (HR <100 bpm or a decrease by at least 20%).
6 secondary outcomes
Successful rate control within 15 minutes
Time frame: 15 minutes
Successful rate control within 60 minutes
Time frame: 60 minutes
Bradycardia
Time frame: 30 minutes
Hypotension
Time frame: 30 minutes
Conversion
Time frame: 30 minutes
Worsening heart failure symptoms
Time frame: 48hr/readmission
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 20 Sep 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Heart Failure, run by RaeAnn Hirschy.
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 1 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: finished, as of the sponsor's last update on 20 Sep 2018. 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?
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?
Successful rate control (time frame: 30 minutes). 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 20 Sep 2018.