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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03830957
• Other study ID #: HFRC_01
• Status: Recruiting
• Phase: N/A
• Start date: November 26, 2018
• Est. completion date: December 2019

Study information

• Verified date: April 2019
• Source: Rajaie Cardiovascular Medical and Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Sinus rhythm

• Heart rate >60/min

Exclusion Criteria:

• Atrial fibrillation

• Any contraindication for beta-blocker use

Related Conditions & MeSH terms

• Bradycardia
• Cardiomyopathies
• CT Angiography
• Heart Failure
• Heart Failure, Diastolic
• Heart Failure, Systolic
• Heart Failure,Congestive
• Heart Rate Low
• Ischemic Cardiomyopathy
• Non-ischemic Cardiomyopathy

Intervention

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
• Metoprolol
5 mg oral single dose if the heart rate would not reach to 60/minute then give another dose, 5 mg

Locations

Country	Name	City	State
Iran, Islamic Republic of	Ahmad Amin	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Rajaie Cardiovascular Medical and Research Center

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate	Changing heart rate during imaging study	30 minutes before and after coronary CT angiography
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Prolonged bradycardia	Persistence of Bradycardia more than 6 hours is called prolonged bradycardia.	30 minutes before and after coronary CT angiography
Secondary	Hypotension	Systolic less than 80 mm Hg	30 minutes before and after coronary CT angiography