Heart rate control: Betablockers or Ivabradine therapy before cardiac computed tomography

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Region Midtjylland

Participant type

Healthy volunteers, Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

9 Dec 2025 → ongoing

Decision date (initial)

2025-10-01

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy

The primary objective is to determine which type and dose of medication – beta-blockers or ivabradine – most rapidly achieves a ≥10% reduction in heart rate in patients with a resting heart rate above 65 beats per minute undergoing evaluation for asymptomatic or symptomatic ischemic heart disease prior to cardiac CT.

Secondary objectives 1

1. The secondary objectives of the study are: 1. To assess the development of heart rate reduction during the monitoring period from 0 to 120 minutes following oral tablet administration of the investigational drug. 2. To assess the development of heart rate reduction during the monitoring period from 120 to 150 minutes following intravenous administration in patients who do not achieve a heart rate below 60 beats per minute after receiving the oral tablet or placebo. 3. To evaluate the frequency and stability of heart rhythm during cardiac CT imaging, measured at the time of contrast administration. 4. To monitor the development of adverse events related to the investigational drug.

Conditions and MedDRA coding

ischemic heart disease

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. 1. Patients scheduled for a cardiac CT scan. 2. Sinus rhythm with a heart rate > 65 beats per minute documented by ECG. 3. Competent patients who have provided written informed consent.

Exclusion criteria 1

1. 1. Age under 30 years 2. Age over 80 years 3. Heart rate greater than 100 bpm 4. BMI greater than 35 5. History of cardiovascular interventions or disease: Percutaneous coronary intervention (PCI, with or without stent), coronary artery bypass grafting (CABG), known ischemic heart disease 6. Pacemaker 7. Acute coronary syndrome (ACS) 8. Known allergy to: Beta-blockers, Ivabradine or administered contrast media 9. Pregnancy or breastfeeding includes potentially pregnant women (pregnancy test required) 10. Heart failure with systolic left ventricular ejection fraction < 45% 11. Impaired renal function: Estimated glomerular filtration rate (eGFR) < 40 ml/min 12. Ongoing treatment with any of the following: Beta-blockers, Ivabradine, Non-dihydropyridine calcium channel blockers (verapamil or diltiazem), Cordarone (amiodarone) 13. Contraindications to beta-blockers or ivabradine, including: Severe asthma, severe chronic obstructive pulmonary disease (COPD), Sick sinus syndrome, Atrioventricular (AV) block (1st, 2nd, or 3rd degree), Hypotension (systolic blood pressure < 110 mmHg), Severe heart failure, Severe restrictive cardiomyopathy, Severe aortic stenosis, Severe circulatory disorders, Certain metabolic conditions, Untreated pheochromocytoma, Concomitant treatment with: Potent CYP3A4 inhibitors, Monoamine oxidase (MAO) inhibitors, CYP2D6 inhibitors, Intravenous calcium channel blockers (type 1 or 2)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary end point measure is the time to a heart rate (mean) lowered by 10% from baseline after adminstration of study drug

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Region Midtjylland

Sponsor organisation

Region Midtjylland

Address

Hospitalsparken 15

City

Herning

Postcode

7400

Country

Denmark

Scientific contact point

Organisation

Region Midtjylland

Contact name

Morten Bottcher

Public contact point

Organisation

Region Midtjylland

Contact name

Morten Bottcher

Third parties 1

Sponsor responsibilities

Article 77 compliance

Region Midtjylland

Contact point sponsor

Region Midtjylland

Article 77 implementation

Region Midtjylland

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 13 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications