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

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?

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Coronary Arterial Disease (CAD) Cardiovascular Diseases Heart Diseases Ischemic Heart Disease (IHD) Myocardial Ischemia Vascular Diseases

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University Clinic of Ischemic Heart Disease

Herning, 7400, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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