NCT07268170

Brief Summary

The goal of this clinical trial is to describe which type and dose of commonly used heart rate reducing drugs (metoprolol, atenolol, or ivabradine) has the swiftest heart rate reduction from baseline in patients aged 30 to 80 years with a heart rate \> 65 beats per minute undergoing cardiac computed tomography for the evaluation of coronary artery disease. The main question it aims to answer is • Which type of heart reducing drug and dose has the swiftest heart rate reduction before cardiac computed tomography?

Trial Health

75
On Track

Trial Health Score

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

Enrollment
350

participants targeted

Target at P75+ for phase_2

Timeline
29mo left

Started Dec 2025

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Study Progress14%
Dec 2025Sep 2028

First Submitted

Initial submission to the registry

November 18, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 5, 2025

Completed
10 days until next milestone

Study Start

First participant enrolled

December 15, 2025

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

Expected
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2028

Last Updated

December 17, 2025

Status Verified

October 1, 2025

Enrollment Period

2.7 years

First QC Date

November 18, 2025

Last Update Submit

December 16, 2025

Conditions

Coronary Arterial Disease (CAD)Ischemic Heart Disease (IHD)

Keywords

Cardiac computed tomographypremedicationmetoprololivabradineatenololheart rate controlheart rate

Outcome Measures

Primary Outcomes (1)

  • Dose and type of drugs with the swiftest heart rate reduction in patients undergoing cardiac computed tomography

    Time in minutes to heart rate (mean) lowered by 10% from baseline after administration of study drug

    From adminstration of study drug to start af cardiac computed tomography, 2 hours

Secondary Outcomes (5)

  • Proportion of patients with heart rate <60 beats per minute

    From adminstration of study drug to start af cardiac computed tomography, 2 hours

  • Total heart rate reduction in beats per minute after 120 minutes

    From adminstration of study drug to start af cardiac computed tomography, 2 hours

  • Number of patients in need of an intravenous betablocker

    From adminstration of study drug to start af cardiac computed tomography, 2 hours

  • Efficacy of intravenous administration of betablocker

    From adminstration of study drug to start af cardiac computed tomography, 2 hours

  • Evaluation of side effects, safety, and tolerability of metoprolol, atenolol, and ivabradine

    From intervention af study drug to phone contact to patient 1 week after cardiac computed tomography

Study Arms (9)

Metoprololtartrat 50 mg

EXPERIMENTAL

Strategy 1

Drug: atenololDrug: Ivabradine

Metoprololtartrat 100 mg

EXPERIMENTAL

Strategy 1

Drug: atenololDrug: Ivabradine

Atenolol 50 mg

EXPERIMENTAL

Strategy 1

Drug: Metoprolol tartrateDrug: Ivabradine

Atenolol 100 mg

EXPERIMENTAL

Strategy 1

Drug: Metoprolol tartrateDrug: Ivabradine

Ivabradine 15 mg

EXPERIMENTAL

Strategy 1

Drug: atenololDrug: Metoprolol tartrate

Ivabradine 7.5 mg

EXPERIMENTAL

Strategy 1

Drug: atenololDrug: Metoprolol tartrate

Fastest dose of betablocker (atenolol 50/100 mg or metoprololtartrat 50/100 mg)

EXPERIMENTAL

Strategy 2

Drug: Ivabradine 7.5/15 mg

Fastest dose of Ivabradine (Ivabradine 7.5/15 mg)

EXPERIMENTAL

Strategy 2

Drug: Atenolol/Metoprolol tartrate

Placebo

PLACEBO COMPARATOR

Strategy 2

Drug: Atenolol/Metoprolol tartrateDrug: Ivabradine 7.5/15 mg

Interventions

atenololDRUG

No studies have compared metoprololtartrat, ivabradine, atenolol and placebo in different doses as drugs before cardiac computed tomography

Ivabradine 15 mgIvabradine 7.5 mgMetoprololtartrat 100 mgMetoprololtartrat 50 mg
Metoprolol tartrateDRUG

No studies have compared metoprololtartrat, ivabradine, atenolol and placebo in different doses as drugs before cardiac computed tomography

Atenolol 100 mgAtenolol 50 mgIvabradine 15 mgIvabradine 7.5 mg
IvabradineDRUG

No studies have compared metoprololtartrat, ivabradine, atenolol and placebo in different doses as drugs before cardiac computed tomography

Atenolol 100 mgAtenolol 50 mgMetoprololtartrat 100 mgMetoprololtartrat 50 mg
Atenolol/Metoprolol tartrateDRUG

No studies have compared metoprololtartrat, ivabradine, atenolol and placebo in different doses as drugs before cardiac computed tomography

Fastest dose of Ivabradine (Ivabradine 7.5/15 mg)Placebo
Ivabradine 7.5/15 mgDRUG

No studies have compared metoprololtartrat, ivabradine, atenolol and placebo in different doses as drugs before cardiac computed tomography

Fastest dose of betablocker (atenolol 50/100 mg or metoprololtartrat 50/100 mg)Placebo

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals who are to undergo Cardiac CT
  • Sinus rhythm with heart rate \> 65 bpm on ECG
  • Competent patients who have given written informed consent

You may not qualify if:

  • Age \> 80 years
  • Age \< 30 years
  • Heart rate \> 100 bpm
  • BMI \> 35
  • Previous percutaneous coronary intervention (with or without stent)
  • Previous CABG
  • Known ischemic heart disease
  • Pacemaker
  • Acute coronary syndrome
  • Known allergy to beta-blockers
  • Known allergy to ivabradine
  • Known allergy to used radiographic contrast agents
  • Pregnant, including potentially pregnant, or breastfeeding (potentially pregnant patients will undergo pregnancy testing)
  • Heart failure with systolic left ventricular ejection fraction \< 45%
  • Reduced kidney function with estimated glomerular filtration rate (eGFR) \< 40 ml/min
  • +21 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Clinic of Ischemic Heart Disease

Herning, 7400, Denmark

Location

MeSH Terms

Conditions

Myocardial Ischemia

Interventions

AtenololMetoprololIvabradine

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Morten Böttcher, Professor

    University Clinic of Ishemic Heart Disease, Gødstrup Hospital

    STUDY CHAIR

  • Simon Winther, MD, PhD

    University Clinic of Ishemic Heart Disease, Gødstrup Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Initial dose-finding pilot study using a controlled, double-blind, 6 armed 1:1 randomized design. Followed by a sequential controlled, double-blind, placebo-controlled study of most effective betablocker and ivabradine dose among a subgroup of diabetics and non-diabetics undergoing cardiac computed tomography.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2025

First Posted

December 5, 2025

Study Start

December 15, 2025

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 30, 2028

Last Updated

December 17, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared with other researchers. All data will be analyzed and managed locally at our site, and we do not plan to share IPD.

Locations

DK(1)