Clinical Trials Directory

Trials / Completed

CompletedNCT02764970

Heart Rate Reducing Therapy in Cardiac CT Using Ivabradine and Bisoprolol

Heart Rate Reducing Therapy With Ivabradine and Bisoprolol Before Coronary Computer Tomographic Angiography in Ambulant Patients

Status
Completed
Phase
Study type
Observational
Enrollment
112 (actual)
Sponsor
Medical University of Graz · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

Summary

Out-patients scheduled for coronary computer tomographic angiography (CCTA) were screened regarding their baseline heart rate. If heart rate was \> 75, patients were pretreated with 10mg bisoprolol (group 1) or 10mg bisoprolol plus 7.5mg ivabradine (group 2) to reduce heart rate one our before CCTA was performed. Heart rate, additional use of i.v. bradycardic agents, motion artefacts, radiation dose and drug tolerance was monitored.

Detailed description

Aim of the study is to evaluate if ivabradine, an inhibitor of the funny channel (If), in addition to bisoprolol is effective in lowering heart rate before coronary computer tomographic angiography (CCTA) if administered orally one hour before the scan. Out-patients of a single radiology center are included in this retrospective analysis. All patients are referred to an ambulant CCTA. All scans are performed with a Siemens Somatom Sensation Cardiac 64 Computer Tomograph and analyzed with Siemens Syngo Plaza software. Patients with an initial heart rate of ≥ 75 bpm are either pretreated with bisoprolol 10mg p.o. alone (group 1) or a combination of bisoprolol 10mg and ivabradine 7.5mg p.o. (group 2) one hour before the CT scan. The change in treatment from bisoprolol only to the combination of bisoprolol and ivabradine was introduced as a change in standard treatment independent of the study. The study was only plannend and performed as a retrospective analysis after the last patient included into the analysis was already treated. Additional betablocker is administered intravenously right before the scan if heart rate remains elevated. The hypothesis is that the addition of ivabradine to bisoprolol results in a pronounced heart rate reduction. This heart rate reduction will lead to a reduced need of i.v. bradicardic drug use, a reduction in motion artifacts and a reduced radiation dose to to a higher rate of flash sequences.

Conditions

Interventions

TypeNameDescription
DRUGIvabradine 7.5mg orallyadditive use to the standard medication with bisoprolol

Timeline

Start date
2015-02-01
Primary completion
2015-09-01
Completion
2016-01-01
First posted
2016-05-06
Last updated
2018-03-19
Results posted
2018-03-19

Source: ClinicalTrials.gov record NCT02764970. Inclusion in this directory is not an endorsement.