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Enrolling by invitation NCT07268170

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

Phase II / Phase III Interventional Coronary Arterial Disease (CAD) Ischemic Heart Disease (IHD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: atenolol, Metoprolol tartrate, Ivabradine, Atenolol/Metoprolol tartrate.
Who it may be relevant to
Registry conditions: Coronary Arterial Disease (CAD), Ischemic Heart Disease (IHD). Basic parameters: 30 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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?

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.

Interventions

  • 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
  • Drug Ivabradine
    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
  • Drug Ivabradine 7.5/15 mg
    No studies have compared metoprololtartrat, ivabradine, atenolol and placebo in different doses as drugs before cardiac computed tomography

Primary outcome measures

  • 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]
Secondary outcome measures (5)
  • Proportion of patients with heart rate <60 beats per minute [Time frame: From adminstration of study drug to start af cardiac computed tomography, 2 hours]
  • Total heart rate reduction in beats per minute after 120 minutes [Time frame: From adminstration of study drug to start af cardiac computed tomography, 2 hours]
  • Number of patients in need of an intravenous betablocker [Time frame: From adminstration of study drug to start af cardiac computed tomography, 2 hours]
  • Efficacy of intravenous administration of betablocker [Time frame: 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 [Time frame: From intervention af study drug to phone contact to patient 1 week after cardiac computed tomography]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Denmark · 1 center
  • University Clinic of Ischemic Heart Disease — Herning

Identifiers

NCT: NCT07268170 · 2025-522741-21-00 · 2025-522741-21-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗