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Coronary Arterial Disease (CAD)Phase 2/3HEART-BEATNCT07268170

Heart Rate Control Before Cardiac Computed Tomography in Adults for the Evaluation of Coronary Artery Disease

A Phase 2/3 study testing atenolol, Metoprolol tartrate and Ivabradine in people with Coronary Arterial Disease (CAD) and Ischemic Heart Disease (IHD), run by Gødstrup Hospital at 1 site in Denmark.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 30 to 80 yearsHealthy volunteers can take part
What is being tested?
atenolol, Metoprolol tartrate and Ivabradine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
350 participants
Where
1 siteDenmark
Study dates
15 Dec 2025to 30 Sep 2028
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Age > 80 years
  • Age < 30 years
  • Heart rate > 100 bpm
  • BMI > 35
  • Previous percutaneous coronary intervention (with or without stent)
  • Previous CABG
Show all 36Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Denmark1 site

  • University Clinic of Ischemic Heart Disease

    Herning, 7400

Other trials in Denmark

About this study

Official title: 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?
Read the 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.

Being tested
atenolol, Metoprolol tartrate, Ivabradine, Atenolol/Metoprolol tartrate, Ivabradine 7.5/15 mg
Keywords
Cardiac computed tomography, premedication, metoprolol, ivabradine, atenolol, heart rate control, heart rate
Medical subject headings
Myocardial Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • atenololDrug

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

  • Metoprolol tartrateDrug

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

  • IvabradineDrug

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

  • Atenolol/Metoprolol tartrateDrug

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

  • Ivabradine 7.5/15 mgDrug

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

Study groups in NCT07268170
Study groupRoleWhat they receive
Metoprololtartrat 50 mgExperimentalStrategy 1
Receives: Drug: atenolol; Drug: Ivabradine
Metoprololtartrat 100 mgExperimentalStrategy 1
Receives: Drug: atenolol; Drug: Ivabradine
Atenolol 50 mgExperimentalStrategy 1
Receives: Drug: Metoprolol tartrate; Drug: Ivabradine
Atenolol 100 mgExperimentalStrategy 1
Receives: Drug: Metoprolol tartrate; Drug: Ivabradine
Ivabradine 15 mgExperimentalStrategy 1
Receives: Drug: atenolol; Drug: Metoprolol tartrate
Ivabradine 7.5 mgExperimentalStrategy 1
Receives: Drug: atenolol; Drug: Metoprolol tartrate
Fastest dose of betablocker (atenolol 50/100 mg or metoprololtartrat 50/100 mg)ExperimentalStrategy 2
Receives: Drug: Ivabradine 7.5/15 mg
Fastest dose of Ivabradine (Ivabradine 7.5/15 mg)ExperimentalStrategy 2
Receives: Drug: Atenolol/Metoprolol tartrate
PlaceboPlacebo comparatorStrategy 2
Receives: Drug: Atenolol/Metoprolol tartrate; Drug: Ivabradine 7.5/15 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (5)

  1. Proportion of patients with heart rate <60 beats per minute

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

  2. Total heart rate reduction in beats per minute after 120 minutes

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

  3. 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

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

  4. Efficacy of intravenous administration of betablocker

    How patients tolerate intravenous betablocker

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

  5. Evaluation of side effects, safety, and tolerability of metoprolol, atenolol, and ivabradine

    Phone contact to patient to describe any side effects and the tolerability

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2025
  2. Study start15 Dec 2025
  3. Primary completion1 Sep 2028 (estimated)
  4. Study completion30 Sep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
350 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07268170
Sponsor's protocol ID
2025-522741-21-00
Other IDs
2025-522741-21-00, 2025
Acronym
HEART-BEAT
Status last verified
Oct 2025
First submitted
18 Nov 2025
Last updated
17 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing atenolol, Metoprolol tartrate and Ivabradine in people with Coronary Arterial Disease (CAD) and Ischemic Heart Disease (IHD), run by Gødstrup Hospital at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose and type of drugs with the swiftest heart rate reduction in patients undergoing cardiac computed tomography (time frame: From adminstration of study drug to start af cardiac computed tomography, 2 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07268170.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.

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