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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE2/PHASE3

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-15

Study Completion Date

2028-09-30

Brief Summary

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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?

Detailed Description

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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

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Metoprololtartrat 50 mg

Strategy 1

Group Type EXPERIMENTAL