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

Gødstrup Hospital

Status and phase: Invitation-only; Phase 3; Phase 2

Conditions: Coronary Arterial Disease (CAD); Ischemic Heart Disease (IHD)

Treatments: Drug: atenolol; Drug: Atenolol/Metoprolol tartrate; Drug: Ivabradine; Drug: Metoprolol tartrate; Drug: Ivabradine 7.5/15 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT07268170

2025-522741-21-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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?

Full 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.

Enrollment: 350 estimated patients

Sex: All

Ages: 30 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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350 participants in 9 patient groups, including a placebo group

Metoprololtartrat 50 mg

Experimental group

Description:

Strategy 1

Treatment:

Drug: Ivabradine

Drug: atenolol

Metoprololtartrat 100 mg

Experimental group

Description:

Strategy 1

Treatment:

Drug: Ivabradine

Drug: atenolol

Atenolol 50 mg

Experimental group

Description:

Strategy 1

Treatment:

Drug: Metoprolol tartrate

Drug: Ivabradine

Atenolol 100 mg

Experimental group

Description:

Strategy 1

Treatment:

Drug: Metoprolol tartrate

Drug: Ivabradine

Ivabradine 15 mg

Experimental group

Description:

Strategy 1

Treatment:

Drug: Metoprolol tartrate

Drug: atenolol

Ivabradine 7.5 mg

Experimental group

Description:

Strategy 1

Treatment:

Drug: Metoprolol tartrate

Drug: atenolol

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

Experimental group

Description:

Strategy 2

Treatment:

Drug: Ivabradine 7.5/15 mg

Fastest dose of Ivabradine (Ivabradine 7.5/15 mg)

Experimental group

Description:

Strategy 2

Treatment:

Drug: Atenolol/Metoprolol tartrate

Placebo

Placebo Comparator group

Description:

Strategy 2

Treatment:

Drug: Ivabradine 7.5/15 mg

Drug: Atenolol/Metoprolol tartrate