NCT07268170

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

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

• Status: Enrolling By Invitation
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 350 (estimated)
• Sponsor: Gødstrup Hospital · Academic / Other
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Accepted

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 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.

Conditions

• Coronary Arterial Disease (CAD)
• Ischemic Heart Disease (IHD)

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-12-15
• Primary completion: 2028-09-01
• Completion: 2028-09-30
• First posted: 2025-12-05
• Last updated: 2025-12-17

Locations

1 site across 1 country: Denmark