Heart Rate Control Before Cardiac Computed Tomography in Adults for the Evaluation of Coronary Artery Disease (HEART-BEAT)

Heart Rate Control: Betablockers or Ivabradine Therapy Before Cardiac Computed Tomography

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?

Study Overview

• Status: Enrolling by invitation
• Conditions: Coronary Arterial Disease (CAD); Ischemic Heart Disease (IHD)
• Intervention / Treatment: Drug: atenolol; Drug: Ivabradine; Drug: Metoprolol tartrate; Drug: Ivabradine 7.5/15 mg; Drug: Atenolol/Metoprolol tartrate

Detailed Description

This single-center, prospective, randomized, double-blind, clinical trial will include patients undergoing cardiac computed tomography. Two phases will be conducted: a pilot study (dose-finding phase) and a randomized trial (superiority phase). In the first dose-finding phase participants (N=150) will be randomized 1:1 in six arms (arms contain lower and higher doses of atenolol, metoprolol and ivabradine). Following an interim analysis, a superiority phase will be conducted using two parallel groups, non-diabetics (N=100) and diabetics (N=100), in a placebo-controlled head-to-head randomized 2:2:1 three-arms trial comparing the fastest betablocker and dose and the fastest dose of ivabradine from the dose-finding phase.

• Study Type: Interventional
• Enrollment (Estimated): 350
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Denmark
  • Herning, Denmark, 7400
    • University Clinic of Ischemic Heart Disease

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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
• Regular treatment with beta-blockers
• Regular treatment with ivabradine
• Regular treatment with non-dihydropyridine calcium antagonists (Verapamil and Diltiazem)
• Regular treatment with Cordarone
• Contraindications for beta-blockers or ivabradine:
• Severe asthma
• Severe COPD
• Sick sinus syndrome
• Sinoatrial block (1st degree AV block)
• Advanced AV block (2nd or 3rd degree)
• Hypotension (systolic blood pressure < 110 mmHg)
• Severe heart failure
• Severe restrictive cardiomyopathy
• Severe aortic stenosis
• Severe circulatory disturbances
• Severe metabolic conditions
• Untreated pheochromocytoma
• Concurrent treatment with potent inhibitors of CYP3A4
• Concurrent treatment with potent inhibitors of MAO inhibitors,
• Concurrent treatment with potent inhibitors of CYP2D6 inhibitors
• Concurrent treatment with potent inhibitors of intravenous calcium antagonists type I or III

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Metoprololtartrat 50 mg; Strategy 1	Drug: atenolol; No studies have compared metoprololtartrat, ivabradine, atenolol and placebo in different doses as drugs before cardiac computed tomography; Drug: Ivabradine; No studies have compared metoprololtartrat, ivabradine, atenolol and placebo in different doses as drugs before cardiac computed tomography
Experimental: Metoprololtartrat 100 mg; Strategy 1	Drug: atenolol; No studies have compared metoprololtartrat, ivabradine, atenolol and placebo in different doses as drugs before cardiac computed tomography; Drug: Ivabradine; No studies have compared metoprololtartrat, ivabradine, atenolol and placebo in different doses as drugs before cardiac computed tomography
Experimental: Atenolol 50 mg; Strategy 1	Drug: Ivabradine; No studies have compared metoprololtartrat, ivabradine, atenolol and placebo in different doses as drugs before cardiac computed tomography; Drug: Metoprolol tartrate; No studies have compared metoprololtartrat, ivabradine, atenolol and placebo in different doses as drugs before cardiac computed tomography
Experimental: Atenolol 100 mg; Strategy 1	Drug: Ivabradine; No studies have compared metoprololtartrat, ivabradine, atenolol and placebo in different doses as drugs before cardiac computed tomography; Drug: Metoprolol tartrate; No studies have compared metoprololtartrat, ivabradine, atenolol and placebo in different doses as drugs before cardiac computed tomography
Experimental: Ivabradine 15 mg; Strategy 1	Drug: atenolol; No studies have compared metoprololtartrat, ivabradine, atenolol and placebo in different doses as drugs before cardiac computed tomography; Drug: Metoprolol tartrate; No studies have compared metoprololtartrat, ivabradine, atenolol and placebo in different doses as drugs before cardiac computed tomography
Experimental: Ivabradine 7.5 mg; Strategy 1	Drug: atenolol; No studies have compared metoprololtartrat, ivabradine, atenolol and placebo in different doses as drugs before cardiac computed tomography; Drug: Metoprolol tartrate; No studies have compared metoprololtartrat, ivabradine, atenolol and placebo in different doses as drugs before cardiac computed tomography
Experimental: Fastest dose of betablocker (atenolol 50/100 mg or metoprololtartrat 50/100 mg); Strategy 2	Drug: Ivabradine 7.5/15 mg; No studies have compared metoprololtartrat, ivabradine, atenolol and placebo in different doses as drugs before cardiac computed tomography
Experimental: Fastest dose of Ivabradine (Ivabradine 7.5/15 mg); Strategy 2	Drug: Atenolol/Metoprolol tartrate; No studies have compared metoprololtartrat, ivabradine, atenolol and placebo in different doses as drugs before cardiac computed tomography
Placebo Comparator: Placebo; Strategy 2	Drug: Ivabradine 7.5/15 mg; No studies have compared metoprololtartrat, ivabradine, atenolol and placebo in different doses as drugs before cardiac computed tomography; Drug: Atenolol/Metoprolol tartrate; No studies have compared metoprololtartrat, ivabradine, atenolol and placebo in different doses as drugs before cardiac computed tomography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Patients with a heart rate >60 beats per minutes after 2 hours after administration of study drug	From adminstration of study drug to start af cardiac computed tomography, 2 hours
Efficacy of intravenous administration of betablocker	How patients tolerate intravenous 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	Phone contact to patient to describe any side effects and the tolerability	From intervention af study drug to phone contact to patient 1 week after cardiac computed tomography

Collaborators and Investigators

• Sponsor: Gødstrup Hospital
• Collaborators: Department of Cardiology, Gødstrup Hospital, Herning, Denmark
• Investigators: Study Chair: Morten Böttcher, Professor, University Clinic of Ishemic Heart Disease, Gødstrup Hospital; Principal Investigator: Simon Winther, MD, PhD, University Clinic of Ishemic Heart Disease, Gødstrup Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 30, 2028

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: December 3, 2025
• First Posted (Estimated): December 5, 2025

Study Record Updates

• Last Update Posted (Actual): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: ivabradine; heart rate; premedication; atenolol; metoprolol; Cardiac computed tomography; heart rate control
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Myocardial Ischemia; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Amines; Alcohols; Benzazepines; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Propanols; Metoprolol; Atenolol; Ivabradine
• Other Study ID Numbers: 2025-522741-21-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

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