Efficacy and Safety of Ivabradine to Reduce Heart Rate Prior to Coronary CT-angiography in Advanced Heart Failure: Comparison With β-Blocker

Study Overview
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Brief Summary
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The aim of this study is to compare the effects of Ivabradine and metoprolol to reduce heart rate prior to coronary CT angiography in patients with advanced heart failure.

Official Title
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Randomized Clinical Trial of Ivabradine to Reduce Heart Rate Prior to Coronary CT-angiography in Advanced Heart Failure: Comparison With β-Blocker

Conditions
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Heart Failure, CT Angiography, Ischemic Cardiomyopathy, Non-ischemic Cardiomyopathy, Heart Failure, Systolic, Heart Failure，Congestive, Heart Failure, Diastolic, Heart Rate Low

Intervention / Treatment
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* Drug: Ivabradine
* Drug: Metoprolol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sinus rhythm Heart rate >60/min Exclusion Criteria: Atrial fibrillation Any contraindication for beta-blocker use

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ivabradine<br> | Drug: Ivabradine<br>* 7.5 mg oral single dose if the heart rate would not reach to 60/minute then give another dose, 7.5 mg<br>|
| Active Comparator: metoprolol<br> | Drug: Metoprolol<br>* 5 mg oral single dose if the heart rate would not reach to 60/minute then give another dose, 5 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate | Changing heart rate during imaging study | 30 minutes before and after coronary CT angiography | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dyspnea | Shortness of breath, or dyspnea, is the most famous symptom of left ventricular failure. It typically appears during strenuous activities, and progresses to ordinary activities, less than ordinary activities and ultimately resting state. The severity is categorized as above (FC 1 to 4) | 30 minutes before and after coronary CT angiography and 6 months later | 
| Functional calss | Heart Failure severity has been classified according to New York Heart Association (NYHA) to: Class I: No limitation of physical activity. Ordinary physical activity does not cause symptoms of HF. Class II: Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in symptoms of HF. Class III: Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes symptoms of HF. Class IV: Unable to perform any physical activity without symptoms of HF, or symptoms of HF at rest. | 30 minutes before and after coronary CT angiography and 6 months later | 
| Blood pressure, systolic and diastolic | The amount of blood pressure measured by sphygmomanometer | 30 minutes before and after coronary CT angiography and 6 months later | 
| Sleep quality | The rate of disturbed sleep measured as better than before, Worse than before, and No change There are no standard classification for severity of this symptom. In our study, we measure this symptom as : Better than before (1) Worse than before (2) No change (0) | Before CT angiography and 6 months later | 
| Appetite | The rate of changing in appetite level measured as better than before, Worse than before, and No change Loss of appetite is a common symptom of heart failure. There are no standard classification for severity of this symptom. In our study, we measure this symptom as : Better than before (1) Worse than before (2) No change (0) | Before CT angiography and 6 months later | 
| Prolonged bradycardia | Persistence of Bradycardia more than 6 hours is called prolonged bradycardia. | 30 minutes before and after coronary CT angiography | 
| Hypotension | Systolic less than 80 mm Hg | 30 minutes before and after coronary CT angiography |