NCT03830957

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P50-P75 for not_applicable heart-failure

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

November 26, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 5, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

April 12, 2019

Status Verified

April 1, 2019

Enrollment Period

1 year

First QC Date

November 26, 2018

Last Update Submit

April 10, 2019

Conditions

Heart FailureCT AngiographyIschemic CardiomyopathyNon-ischemic CardiomyopathyHeart Failure, SystolicHeart Failure，CongestiveHeart Failure, DiastolicHeart Rate Low

Outcome Measures

Primary Outcomes (1)

  • Heart rate

    Changing heart rate during imaging study

    30 minutes before and after coronary CT angiography

Secondary Outcomes (7)

  • Dyspnea

    30 minutes before and after coronary CT angiography and 6 months later

  • Functional calss

    30 minutes before and after coronary CT angiography and 6 months later

  • Blood pressure, systolic and diastolic

    30 minutes before and after coronary CT angiography and 6 months later

  • Sleep quality

    Before CT angiography and 6 months later

  • Appetite

    Before CT angiography and 6 months later

  • +2 more secondary outcomes

Study Arms (2)

Ivabradine

ACTIVE COMPARATOR
Drug: Ivabradine

metoprolol

ACTIVE COMPARATOR
Drug: Metoprolol

Interventions

IvabradineDRUG

7.5 mg oral single dose if the heart rate would not reach to 60/minute then give another dose, 7.5 mg

Ivabradine
MetoprololDRUG

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

metoprolol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Sinus rhythm
  • Heart rate \>60/min

You may not qualify if:

  • Atrial fibrillation
  • Any contraindication for beta-blocker use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmad Amin

Tehran, 1996911151, Iran

RECRUITING

MeSH Terms

Conditions

Heart FailureHeart Failure, SystolicHeart Failure, DiastolicBradycardia

Interventions

IvabradineMetoprolol

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesArrhythmias, CardiacPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAmines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2018

First Posted

February 5, 2019

Study Start

November 26, 2018

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

April 12, 2019

Record last verified: 2019-04

Locations

IR(1)