Evaluation of heart rate lowering effects with ivabradine in patients with angina in the hospital
| ISRCTN | ISRCTN14549448 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14549448 |
| Secondary identifying numbers | IC4-16257-007-MAR |
- Submission date
- 29/12/2022
- Registration date
- 07/02/2023
- Last edited
- 07/02/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Angina pectoris is chest pain or discomfort due to coronary heart disease. Several studies have proven the benefit of Ivabradine, not only in the management of angina pectoris. The aim of this study is to observe, under actual prescribing conditions over a period of 4 months, the effects of an exclusive reduction of heart rate with Ivabradine in angina coronary patients.
Who can participate?
Patients aged 18 years and older with stable coronary artery disease
What does the study involve?
All patients for whom the investigator prescribed ivabradine in accordance with current clinical practice for treating patients with angina. Their heart rate is measured and their functional improvement graded using the Canadian Cardiovascular Society grading of Angina Pectoris system. Physician satisfaction is also graded to determine the tolerance, efficacy and effectiveness of ivabradine.
What are the possible benefits and risks of participating?
There are no risks to the participants.
Where is the study run from?
Sponsored by Servier Morocco, managed by Gaya CRO (Morocco)
When is the study starting and how long is it expected to run for?
October 2017 to April 2019
Who is funding the study?
Servier Maroc (Morocco)
Who is the main contact?
Fouzia EL HARRANE, fouzia.el-harrane@servier.com
Contact information
Scientific
23, angle rue banimalik & rue ait zekri, aviation
Rabat
10000
Morocco
| Phone | +212 (0)703112122 |
|---|---|
| dansong@gaya-holding.com |
Study information
| Study design | Non-interventional non-comparative open cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant infromation sheet |
| Scientific title | ESSENTIEL Hospital: observation of exclusive heart rate reduction effects with ivabradine in angina patients in a hospital setting |
| Study acronym | ESSENTEIL |
| Study objectives | This is an observational study to observe the effects of an exclusive reduction of heart rate (HR) with ivabradine in stable coronary artery disease. |
| Ethics approval(s) | Approved 22/03/2018, Ethics Committee for Biomedical Research (CERB; Faculty of Medicine and Pharmacy- Rabat, Imp. Souissi, Rabat 10100, Morocco; +212 (0)537773560; guedirak@yahoo.fr), ref: 61/18 |
| Health condition(s) or problem(s) studied | Coronary artery disease (CAD) and angina |
| Intervention | This is an observational study. Each investigator recruited 10 patients presenting symptomatic stable coronary artery disease. The decision to prescribe ivabradine was made by the physician independently of the patient's inclusion in the study. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Ivabradine (Coralan) |
| Primary outcome measure | 1. HR measured by electrocardiogram at baseline, after 1 month and after 4 months 2. CCS grades determined using the Canadian Cardiovascular Society grading of angina pectoris system at baseline, after 1 month and after 4 months |
| Secondary outcome measures | Physician satisfaction assessed by rating the tolerability, efficacy, and effectiveness of ivabradine on a scale of 0 to 5 after 4 months of ivabradine treatment |
| Overall study start date | 30/10/2017 |
| Completion date | 02/04/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 125 |
| Total final enrolment | 125 |
| Key inclusion criteria | Inclusion criteria: as per current SmPC 1. Patients 18 years and older 2. Female or male 3. Patients with documented stable coronary artery disease with or without left ventricular dysfunction (LVD); example: with angina, history of revascularization, history of myocardial infarction, or angiographic evidence of at least 70% stenosis of one of the major coronary arteries 4. Patient with stable angina diagnosed more than 6 months ago 5. HR resting >70 bpm 6. Patients inadequately controlled despite an optimal dose of beta-blockers |
| Key exclusion criteria | Exclusion criteria: according to current SmPC 1. Known hypersensitivity to the active substance or any of the excipients 2. Resting heart rate of fewer than 70 beats per minute prior to treatment 3. Cardiogenic shock 4. Acute myocardial infarction 5. Severe hypotension (<90/50 mmHg) 6. Severe liver failure 7. Sick sinus syndrome 8. Atrial sinus block 9. Unstable or acute heart failure 10. Pacemaker-dependent patient (heart rate exclusively imposed by the pacemaker) 11. Unstable angina 12. Third-degree atrioventricular (AV) block 13. Combination with potent cytochrome P450 3A4 inhibitors, such as azole antifungals (ketoconazole, itraconazole), macrolide antibiotics (clarithromycin, erythromycin per os, josamycin, telithromycin), protease inhibitors (nelfinavir, ritonavir) or nefazodone 14. Combination with verapamil or diltiazem, moderate CYP 3A4 inhibitors with bradycardic effects 15. Pregnancy, breastfeeding and women of childbearing age not using effective contraception |
| Date of first enrolment | 05/01/2018 |
| Date of final enrolment | 02/04/2019 |
Locations
Countries of recruitment
- Morocco
Study participating centre
10000
Morocco
Sponsor information
Industry
Immeuble ZEVACO. Lotissement Fath 4
Bd Abdelhadi Boutaleb
Casablanca
20180
Morocco
| Phone | +212 (0)669281017 |
|---|---|
| fouzia.el-harrane@servier.com | |
| Website | https://servier.ma/ |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/12/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal in 2023 |
| IPD sharing plan | The datasets generated during and/or analysed in the current study are not expected to be made available due to the data privacy of Morocco. |
Editorial Notes
30/12/2022: Trial's existence confirmed by the Ethics Committee for Biomedical Research.
