IVABRADINE for Ischemic heart disease

Inclusion criteria

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

Exclusion criteria

• {"criterion_text":"- 1. Age under 30 years"}
• {"criterion_text":"- 2. Age over 80 years"}
• {"criterion_text":"- 3. Heart rate greater than 100 bpm"}
• {"criterion_text":"- 4. BMI greater than 35"}
• {"criterion_text":"- 5. History of cardiovascular interventions or disease: Percutaneous coronary intervention (PCI, with or without stent), coronary artery bypass grafting (CABG), known ischemic heart disease"}
• {"criterion_text":"- 6. Pacemaker"}
• {"criterion_text":"- 7. Acute coronary syndrome (ACS)"}
• {"criterion_text":"- 8. Known allergy to: Beta-blockers, Ivabradine or administered contrast media"}
• {"criterion_text":"- 9. Pregnancy or breastfeeding includes potentially pregnant women (pregnancy test required)"}
• {"criterion_text":"- 10. Heart failure with systolic left ventricular ejection fraction < 45%"}
• {"criterion_text":"- 11. Impaired renal function: Estimated glomerular filtration rate (eGFR) < 40 ml/min"}
• {"criterion_text":"- 12. Ongoing treatment with any of the following: Beta-blockers, Ivabradine, Non-dihydropyridine calcium channel blockers (verapamil or diltiazem), Cordarone (amiodarone)"}
• {"criterion_text":"- 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)"}

Primary endpoints

• {"endpoint_text":"- The primary end point measure is the time to a heart rate (mean) lowered by 10% from baseline after adminstration of study drug","definition_or_measurement_approach":"Measured as the time from administration of study drug to a mean heart rate reduction of 10% from baseline; heart rate measured by ECG/monitoring during the post-dose monitoring period (per study objectives describing 0–120 minutes for oral tablet and 120–150 minutes for possible intravenous administration)."}

Denmark

Earliest CTIS Part Ii Submission Date

17-09-2025

Latest Decision Or Authorization Date

01-10-2025

Processing Time Days

14

Number Of Sites

1

Number Of Participants

350

Primary sponsor

Full Name

Region Midtjylland

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Aarhus Universitet","duties_or_roles":"sponsorDuties code: 1","organisation_type":"Educational Institution"}