- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02938260
Diltiazem vs. Metoprolol in the Acute Management of AF in Patients With HFrEF
Diltiazem vs. Metoprolol in the Acute Management of Atrial Fibrillation in Patients With Heart Failure With Reduced Ejection Fraction
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Diltiazem
|
|
Metoprolol
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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%).
|
30 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Successful rate control within 15 minutes
Time Frame: 15 minutes
|
Successful rate control within 15 minutes
|
15 minutes
|
Successful rate control within 60 minutes
Time Frame: 60 minutes
|
Successful rate control within 60 minutes
|
60 minutes
|
Bradycardia
Time Frame: 30 minutes
|
HR <60 bpm
|
30 minutes
|
Hypotension
Time Frame: 30 minutes
|
SBP <90 mmHg
|
30 minutes
|
Conversion
Time Frame: 30 minutes
|
conversion to sinus rhythm
|
30 minutes
|
Worsening heart failure symptoms
Time Frame: 48hr/readmission
|
new inotropic support, new pulmonary edema, or increased O2 requirement within 48 hr or readmission within 7 days of discharge
|
48hr/readmission
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Arrhythmias, Cardiac
- Heart Failure
- Atrial Fibrillation
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Vasodilator Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Membrane Transport Modulators
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Sympatholytics
- Adrenergic beta-1 Receptor Antagonists
- Metoprolol
- Diltiazem
Other Study ID Numbers
- 16090607
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Heart Failure
-
Tufts Medical CenterMetro West Medical CenterCompletedCongestive Heart Failure | Diastolic Heart Failure | Systolic Heart FailureUnited States
-
Abbott Medical DevicesCompletedHeart Failure | Heart Failure, Diastolic | Heart Failure, Systolic | Heart Failure NYHA Class II | Heart Failure NYHA Class III | Heart Failure With Reduced Ejection Fraction | Heart Failure NYHA Class IV | Heart Failure With Normal Ejection Fraction | Heart Failure; With Decompensation | Heart Failure...United States, Canada
-
Manipal UniversityUnknownHeart Failure | Decompensated Heart Failure | Acute Heart Failure | Diastolic Heart Failure | Systolic Heart FailureIndia
-
VA Eastern Colorado Health Care SystemNational Institute on Aging (NIA)CompletedHeart Failure | Heart Failure, Diastolic | Heart Failure, Systolic | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection Fraction | Heart Failure; With Decompensation | Heart Failure,Congestive | Heart Failure AcuteUnited States
-
University Hospital, MontpellierCompletedHeart Failure | Diastolic Heart Failure | Systolic Heart Failure Stage CFrance
-
Wake Forest UniversityCompletedHeart Failure, Congestive | Heart Failure With Preserved Ejection Fraction
-
Lancaster General HospitalLouise von Hess Medical Research InstituteEnrolling by invitationDiastolic Heart FailureUnited States
-
Wake Forest UniversityNational Institute on Aging (NIA)CompletedHeart Failure, Congestive | Diastolic Heart FailureUnited States
-
Giresun UniversityIstanbul University - Cerrahpasa (IUC)RecruitingHeart Failure | Diastolic Heart Failure | Systolic Heart FailureTurkey
-
US Department of Veterans AffairsCompleted
Clinical Trials on Metoprolol vs Diltiazem
-
University of VermontRecruitingAtrial Fibrillation | Diastolic Dysfunction | HFpEF - Heart Failure With Preserved Ejection FractionUnited States
-
Asker & Baerum HospitalVestre Viken Hospital Trust; Helse Sor-OstCompletedAtrial Fibrillation | Permanent Atrial FibrillationNorway
-
Verastem, Inc.CompletedNon Small Cell Lung Cancer | KRAS Activating MutationUnited States, Spain, France, Germany, Italy
-
Northwestern UniversityNational Institute on Aging (NIA)Active, not recruitingCognitive Impairment | Alzheimer DiseaseUnited States
-
Verastem, Inc.GOG Foundation; European Network of Gynaecological Oncological Trial Groups...Active, not recruitingOvarian Cancer | Low Grade Ovarian Serous AdenocarcinomaSpain, United States, Belgium, United Kingdom, France, Canada, Italy
-
University Children's Hospital, ZurichCompletedTime Until Identification of Defined ParameterSwitzerland
-
University of PennsylvaniaNational Institute of Mental Health (NIMH)RecruitingMemory ConsolidationUnited States
-
Weill Medical College of Cornell UniversityWithdrawn
-
Gruppo Italiano Studio LinfomiCompleted
-
Boston UniversityWithdrawnAtrial FibrillationUnited States