Ivabradine versus metoprolol for heart rate reduction before coronary computed tomography angiography: a randomised trial
| ISRCTN | ISRCTN74875961 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74875961 |
| Protocol serial number | N/A |
| Sponsor | Medical University of Vienna (Austria) |
| Funder | Medical University of Vienna (Austria) |
- Submission date
- 21/09/2009
- Registration date
- 01/10/2009
- Last edited
- 07/09/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Philipp Pichler
Scientific
Scientific
Waehringer Guertel 18-20
Vienna
1090
Austria
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional single centre single-blind randomised study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Oral premedication with ivabradine versus metoprolol for heart rate reduction before coronary computed tomography angiography: a randomised trial |
| Study objectives | 1. Oral premedication with either ivabradine or metoprolol provides sufficient heart rate control in patients before coronary computed tomography angiography 2. Ivabradine leads to less blood pressure drop compared to metoprolol |
| Ethics approval(s) | Ethics Committee of the Privatklinik Josefstadt approved on the 18th January 2007 (ref: 002/2007) |
| Health condition(s) or problem(s) studied | Coronary artery disease |
| Intervention | Oral medication with 15 mg ivabradine versus 50 mg metoprolol before coronary computed tomography angiography. Drugs were administered once with a one-time follow-up 1 - 3 hours after intervention. |
| Intervention type | Drug |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Ivabradine, metoprolol |
| Primary outcome measure(s) |
Heart rate reduction 60 - 180 minutes after medication |
| Key secondary outcome measure(s) |
Systolic blood pressure before versus after medication |
| Completion date | 31/05/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 120 |
| Key inclusion criteria | 1. Sinus rhythm 2. Heart rate greater than or equal to 60 bpm 3. Systolic blood pressure greater than or equal to 100 mmHg 4. Aged greater than or equal to 19 years irrespective of gender |
| Key exclusion criteria | 1. Known allergy to iodinated contrast media 2. Impaired renal function (creatinine serum level greater than 1.5 mg/dl) 3. Thyroid disorder 4. Unstable clinical condition 5. Frequent premature heartbeats 6. Sick-sinus-syndrome 7. Sinoatrial block 8. Second or third degree AV-block 9. Previous pacemaker implantation |
| Date of first enrolment | 01/03/2007 |
| Date of final enrolment | 31/05/2008 |
Locations
Countries of recruitment
- Austria
Study participating centre
Waehringer Guertel 18-20
Vienna
1090
Austria
1090
Austria
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
