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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-522741-21-00 | EU Trial (CTIS) Number |
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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?
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metoprololtartrat 50 mg | Experimental | Strategy 1 |
|
| Metoprololtartrat 100 mg | Experimental | Strategy 1 |
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| Atenolol 50 mg | Experimental | Strategy 1 |
|
| Atenolol 100 mg | Experimental | Strategy 1 |
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| Ivabradine 15 mg | Experimental | Strategy 1 |
|
| Ivabradine 7.5 mg | Experimental | Strategy 1 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| atenolol | Drug | No studies have compared metoprololtartrat, ivabradine, atenolol and placebo in different doses as drugs before cardiac computed tomography |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From adminstration of study drug to start af cardiac computed tomography, 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with heart rate <60 beats per minute | From adminstration of study drug to start af cardiac computed tomography, 2 hours | |
| Total heart rate reduction in beats per minute after 120 minutes | From adminstration of study drug to start af cardiac computed tomography, 2 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Morten Böttcher, Professor | University Clinic of Ishemic Heart Disease, Gødstrup Hospital | Study Chair |
| Simon Winther, MD, PhD | University Clinic of Ishemic Heart Disease, Gødstrup Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Clinic of Ischemic Heart Disease | Herning | 7400 | Denmark |
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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Initial dose-finding pilot study using a controlled, double-blind, 6 armed 1:1 randomized design.
Followed by a sequential controlled, double-blind, placebo-controlled study of most effective betablocker and ivabradine dose among a subgroup of diabetics and non-diabetics undergoing cardiac computed tomography.
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| Fastest dose of betablocker (atenolol 50/100 mg or metoprololtartrat 50/100 mg) | Experimental | Strategy 2 |
|
| Fastest dose of Ivabradine (Ivabradine 7.5/15 mg) | Experimental | Strategy 2 |
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| Placebo | Placebo Comparator | Strategy 2 |
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| Metoprolol tartrate | Drug | No studies have compared metoprololtartrat, ivabradine, atenolol and placebo in different doses as drugs before cardiac computed tomography |
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| Ivabradine | Drug | No studies have compared metoprololtartrat, ivabradine, atenolol and placebo in different doses as drugs before cardiac computed tomography |
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| Atenolol/Metoprolol tartrate | Drug | No studies have compared metoprololtartrat, ivabradine, atenolol and placebo in different doses as drugs before cardiac computed tomography |
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| Ivabradine 7.5/15 mg | Drug | No studies have compared metoprololtartrat, ivabradine, atenolol and placebo in different doses as drugs before cardiac computed tomography |
|
| 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 | From adminstration of study drug to start af cardiac computed tomography, 2 hours |
| Efficacy of intravenous administration of betablocker | How patients tolerate intravenous betablocker | 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 | From intervention af study drug to phone contact to patient 1 week after cardiac computed tomography |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D001262 | Atenolol |
| D008790 | Metoprolol |
| D000077550 | Ivabradine |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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