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

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

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.

Study Overview

• Status: Unknown
• Conditions: Heart Failure; Heart Failure, Diastolic; Heart Failure, Systolic; Ischemic Cardiomyopathy; Heart Rate Low; Heart Failure，Congestive; CT Angiography; Non-ischemic Cardiomyopathy
• Intervention / Treatment: Drug: Ivabradine; Drug: Metoprolol

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of, 1996911151
    • Recruiting
    • Ahmad Amin
    • Contact: Ahmad Amin, MD; Phone Number: 2172 +98 21 2392; Email: amina33@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Sinus rhythm
• Heart rate >60/min

Exclusion Criteria:

• Atrial fibrillation
• Any contraindication for beta-blocker use

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Ivabradine	Drug: Ivabradine; 7.5 mg oral single dose if the heart rate would not reach to 60/minute then give another dose, 7.5 mg
ACTIVE_COMPARATOR: metoprolol	Drug: Metoprolol; 5 mg oral single dose if the heart rate would not reach to 60/minute then give another dose, 5 mg

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rajaie Cardiovascular Medical and Research Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 26, 2018
• Primary Completion (ANTICIPATED): December 1, 2019
• Study Completion (ANTICIPATED): December 1, 2019

Study Registration Dates

• First Submitted: November 26, 2018
• First Submitted That Met QC Criteria: February 2, 2019
• First Posted (ACTUAL): February 5, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 12, 2019
• Last Update Submitted That Met QC Criteria: April 10, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Failure; Bradycardia; Cardiomyopathies; Heart Failure, Diastolic; Heart Failure, Systolic; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Autonomic Agents; Peripheral Nervous System Agents; Sympatholytics; Adrenergic beta-1 Receptor Antagonists; Metoprolol
• Other Study ID Numbers: HFRC_01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No