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

Primary Purpose

Heart Failure, CT Angiography, Ischemic Cardiomyopathy

Status
Unknown status
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Ivabradine
Metoprolol
Sponsored by
Rajaie Cardiovascular Medical and Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Sinus rhythm
  • Heart rate >60/min

Exclusion Criteria:

  • Atrial fibrillation
  • Any contraindication for beta-blocker use

Sites / Locations

  • Ahmad AminRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Ivabradine

metoprolol

Arm Description

Outcomes

Primary Outcome Measures

Heart rate
Changing heart rate during imaging study

Secondary Outcome Measures

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)
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.
Blood pressure, systolic and diastolic
The amount of blood pressure measured by sphygmomanometer
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)
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)
Prolonged bradycardia
Persistence of Bradycardia more than 6 hours is called prolonged bradycardia.
Hypotension
Systolic less than 80 mm Hg

Full Information

First Posted
November 26, 2018
Last Updated
April 10, 2019
Sponsor
Rajaie Cardiovascular Medical and Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT03830957
Brief Title
Efficacy and Safety of Ivabradine to Reduce Heart Rate Prior to Coronary CT-angiography in Advanced Heart Failure: Comparison With β-Blocker
Official Title
Randomized Clinical Trial of Ivabradine to Reduce Heart Rate Prior to Coronary CT-angiography in Advanced Heart Failure: Comparison With β-Blocker
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 26, 2018 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rajaie Cardiovascular Medical and Research Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, CT Angiography, Ischemic Cardiomyopathy, Non-ischemic Cardiomyopathy, Heart Failure, Systolic, Heart Failure,Congestive, Heart Failure, Diastolic, Heart Rate Low

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ivabradine
Arm Type
Active Comparator
Arm Title
metoprolol
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Ivabradine
Intervention Description
7.5 mg oral single dose if the heart rate would not reach to 60/minute then give another dose, 7.5 mg
Intervention Type
Drug
Intervention Name(s)
Metoprolol
Intervention Description
5 mg oral single dose if the heart rate would not reach to 60/minute then give another dose, 5 mg
Primary Outcome Measure Information:
Title
Heart rate
Description
Changing heart rate during imaging study
Time Frame
30 minutes before and after coronary CT angiography
Secondary Outcome Measure Information:
Title
Dyspnea
Description
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)
Time Frame
30 minutes before and after coronary CT angiography and 6 months later
Title
Functional calss
Description
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.
Time Frame
30 minutes before and after coronary CT angiography and 6 months later
Title
Blood pressure, systolic and diastolic
Description
The amount of blood pressure measured by sphygmomanometer
Time Frame
30 minutes before and after coronary CT angiography and 6 months later
Title
Sleep quality
Description
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)
Time Frame
Before CT angiography and 6 months later
Title
Appetite
Description
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)
Time Frame
Before CT angiography and 6 months later
Title
Prolonged bradycardia
Description
Persistence of Bradycardia more than 6 hours is called prolonged bradycardia.
Time Frame
30 minutes before and after coronary CT angiography
Title
Hypotension
Description
Systolic less than 80 mm Hg
Time Frame
30 minutes before and after coronary CT angiography

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Sinus rhythm Heart rate >60/min Exclusion Criteria: Atrial fibrillation Any contraindication for beta-blocker use
Facility Information:
Facility Name
Ahmad Amin
City
Tehran
ZIP/Postal Code
1996911151
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmad Amin, MD
Phone
+98 21 2392
Ext
2172
Email
amina33@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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