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

Not Applicable

• Conditions: Heart Failure; Heart Rate Low; Ischemic Cardiomyopathy; CT Angiography; Non-ischemic Cardiomyopathy; Heart Failure, Systolic; Heart Failure，Congestive; Heart Failure, Diastolic
• Interventions: Drug: Ivabradine; Drug: Metoprolol

• Registration Number: NCT03830957
• Lead Sponsor: Rajaie Cardiovascular Medical and Research Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-26
• Study First Submitted: 2018-11-26
• Study First Submitted QC: 2019-02-02
• Study First Posted: 2019-02-05
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-10
• Last Update Posted: 2019-04-12
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Sinus rhythm
• Heart rate >60/min

Exclusion Criteria

• Atrial fibrillation
• Any contraindication for beta-blocker use

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ivabradine	Ivabradine	-
metoprolol	Metoprolol	-

Primary Outcome Measures

Name	Time	Method
Heart rate	30 minutes before and after coronary CT angiography	Changing heart rate during imaging study

Secondary Outcome Measures

Name	Time	Method
Dyspnea	30 minutes before and after coronary CT angiography and 6 months later	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)
Blood pressure, systolic and diastolic	30 minutes before and after coronary CT angiography and 6 months later	The amount of blood pressure measured by sphygmomanometer
Hypotension	30 minutes before and after coronary CT angiography	Systolic less than 80 mm Hg
Sleep quality	Before CT angiography and 6 months later	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)
Functional calss	30 minutes before and after coronary CT angiography and 6 months later	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.
Appetite	Before CT angiography and 6 months later	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)
Prolonged bradycardia	30 minutes before and after coronary CT angiography	Persistence of Bradycardia more than 6 hours is called prolonged bradycardia.

Trial Locations

Locations (1)

Ahmad Amin; 🇮🇷 Tehran, Iran, Islamic Republic of