A Phase 2/3 interventional study of atenolol and Metoprolol tartrate in Coronary Arterial Disease (CAD) and Ischemic Heart Disease (IHD), sponsored by Gødstrup Hospital. Enrolling by invitation at 1 site in Denmark. Open to participants aged 30 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-17.
Sponsored by Gødstrup Hospital · Phase 2/3, Interventional, and Treatment
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
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.
3,233 studies on the registry are indexed under Myocardial Ischemia; 396 are open to participants now.
This study's planned enrollment of 350 is above the median of 120 across 1,895 interventional studies indexed under Myocardial Ischemia.
Browse Myocardial Ischemia studies →Gødstrup Hospital is the lead sponsor of 24 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Strategy 1
Drug: atenolol · Drug: Ivabradine
Strategy 1
Drug: atenolol · Drug: Ivabradine
Strategy 1
Drug: Metoprolol tartrate · Drug: Ivabradine
Strategy 1
Drug: Metoprolol tartrate · Drug: Ivabradine
Strategy 1
Drug: atenolol · Drug: Metoprolol tartrate
Strategy 1
Drug: atenolol · Drug: Metoprolol tartrate
Strategy 2
Drug: Ivabradine 7.5/15 mg
Strategy 2
Drug: Atenolol/Metoprolol tartrate
Strategy 2
Drug: Atenolol/Metoprolol tartrate · Drug: Ivabradine 7.5/15 mg
No studies have compared metoprololtartrat, ivabradine, atenolol and placebo in different doses as drugs before cardiac computed tomography
No studies have compared metoprololtartrat, ivabradine, atenolol and placebo in different doses as drugs before cardiac computed tomography
No studies have compared metoprololtartrat, ivabradine, atenolol and placebo in different doses as drugs before cardiac computed tomography
No studies have compared metoprololtartrat, ivabradine, atenolol and placebo in different doses as drugs before cardiac computed tomography
No studies have compared metoprololtartrat, ivabradine, atenolol and placebo in different doses as drugs before cardiac computed tomography
Dose and type of drugs with the swiftest heart rate reduction in patients undergoing cardiac computed tomography
Time in minutes to heart rate (mean) lowered by 10% from baseline after administration of study drug
Time frame: From adminstration of study drug to start af cardiac computed tomography, 2 hours
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
Patients with a heart rate \>60 beats per minutes after 2 hours after administration of study drug
Time frame: From adminstration of study drug to start af cardiac computed tomography, 2 hours
Efficacy of intravenous administration of betablocker
How patients tolerate intravenous 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
Phone contact to patient to describe any side effects and the tolerability
Time frame: From intervention af study drug to phone contact to patient 1 week after cardiac computed tomography
Plan to share: No — Individual participant data (IPD) will not be shared with other researchers. All data will be analyzed and managed locally at our site, and we do not plan to share IPD.
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Gødstrup Hospital