Observational educational study assessing efficacy of training of physicians and hypertensive patients treated with Perindopril/Indapamide single pill combination to improve antihypertensive efficacy and treatment compliance
| ISRCTN | ISRCTN14315146 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14315146 |
| Secondary identifying numbers | IC4-06597-011-RUS |
- Submission date
- 25/09/2019
- Registration date
- 18/11/2019
- Last edited
- 03/02/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
In clinical practice, doctors may struggle to get their patients’ blood pressure controlled, and patients might not follow their recommended treatment.
The aim of this study is to assess if training of the physicians and patients with essential hypertension and use of the single-pill combination of the blood pressure controlling drugs perindopril/indapamide may improve hypertensive efficacy of treatment and treatment compliance.
Who can participate?
Patients with essential hypertension
What does the study involve?
This study collects data from patients treated with the drug perindopril arginine 10 mg/indapamide 2.5 mg (alone or in addition to other antihypertensive drugs), according to their doctor’s decision. Patients are assigned into one of the three groups. In group 1, patients are followed-up by the physician according to routine clinical practice; in group 2, physicians receive training; in group 3, physicians receive training and patients are trained in self-monitoring of BP. All patients received the treatment with single pill combination perindopril/indapamide.
What are the possible benefits and risks of participating?
In this study the decision about an administration of single pill combination perindopril/indapamide was made by the physician in accordance with clinical practice. Therefore, any potential drug-related benefit or risk is linked to label for this drug.
Where is the study run from?
Department of Preventive and Emergency Cardiology, Sechenov First Moscow State Medical University
When is the study starting and how long is it expected to run for?
November 2014 to April 2016
Who is funding the study?
Servier Pharmaceuticals
Who is the main contact?
Prof. Maria Glezer
287ast@mail.ru
Contact information
Scientific
Department of Preventive and Emergency Cardiology, Sechenov First Moscow State Medical University. 2-4 Bolshaya Pirogovskaya st.
Moscow
119991
Russian Federation
 ORCID ID |
0000-0002-0995-1924 |
|---|---|
| Phone | +7(985)7630420 |
| rektorat@sechenov.ru |
Study information
| Study design | Non-interventional educational multicenter open-label study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Non-interventional educational multicenter open-label study to assess efficacy of training of the physicians and patients with essential hypertension receiving Perindopril/Indapamide single-pill combination to achieve the target levels of blood pressure and to increase the treatment compliance |
| Study acronym | FORSAGE |
| Study objectives | Physician and patient training and use of single-pill combination of perindopril/indapamide may improve antihypertensive efficacy and treatment compliance |
| Ethics approval(s) | Approved 20/06/2014, Interuniversity Ethical Committee (119002, 37, bld. 2, Gagarinsky Lane, Moscow, tel. +7 (916) 2607664), ref: 06-14 |
| Health condition(s) or problem(s) studied | Arterial hypertension |
| Intervention | This study collects data from patients treated with the drug perindopril arginine 10 mg/indapamide 2.5 mg (alone or in addition to other antihypertensive drugs), according to their doctor’s decision. Patients are assigned into one of the three groups. In group 1, patients are followed-up by the physician according to routine clinical practice; in group 2, physicians receive training; in group 3, physicians receive training and patients are trained in self-monitoring of blood pressure. Patient blood pressure, as well as safety, is evaluated at baseline, then 2 weeks, 1 and 3 months after starting treatment with perindopril/indapamide single pill combination. Questionnaires are administered at baseline and end of the study. The physician training includes the detailed consulting of the patient in problems of arterial hypertension (AH), providing of printed matter regarding the problem of AH, blood pressure (BP) control, diet in patients with AH, physical load, quitting smoking. |
| Intervention type | Other |
| Primary outcome measure | Blood pressure (mmHg) at baseline and 3-months |
| Secondary outcome measures | 1. Achievement of target levels of BP 2. Treatment compliance 3. Adverse Event/Adverse Reaction |
| Overall study start date | 12/04/2014 |
| Completion date | 18/04/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 2000 |
| Total final enrolment | 1969 |
| Key inclusion criteria | 1. Adult patients (≥18 years) 2. Essential hypertension 3. BP > 150 /90 mmHg at the background of the current therapy 4. Physician’s decision to administer Perindopril/Indapamide Single-Pill Combination due to inefficacy of the previous monotherapy or combination therapy and according to the indications 5. Patient’s consent to participate in the study |
| Key exclusion criteria | 1. Secondary hypertension 2. Pregnancy, breast-feeding 3. Severe cardiovascular disease (acute myocardial infarction or acute cerebrovascular accident within the last 6 months) 4. Diabetes mellitus in the stage of decompensation 5. Severe hepatic impairment 6. Renal transplantation 7. Nephrectomy or the presence of a single kidney 8. Hypokalemia or hyperkalemia 9. Chronic alcoholism, abuse of drugs 10. Contraindications for taking indapamide/perindopril arginine 2.5 mg/10mg or individual components 11. History of ACEi/indapamide/sulfonamide intolerance 12. Systemic connective tissue diseases 13. Aortic stenosis 14. Malignant neoplasm 15. Hypersensitivity reactions of any etiology 16. Presence of indapamide 1.25 mg/perindopril 5 mg or indapamide 2.5 mg/ perindopril 10 mg or free combination of its compounds (perindopril/indapamide) in a current therapy |
| Date of first enrolment | 01/11/2014 |
| Date of final enrolment | 28/02/2015 |
Locations
Countries of recruitment
- Russian Federation
Study participating centre
Moscow
119991
Russian Federation
Sponsor information
Industry
bld.7, Lesnaja str.
Moscow
125196
Russian Federation
| Phone | +7(495) 937-0700 |
|---|---|
| natalya.logunova@servier.com | |
"ROR" |
https://ror.org/034e7c066 |
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Servier Laboratories, Laboratoires Servier
- Location
- France
Results and Publications
| Intention to publish date | 31/03/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | We are planning the publication in the journal Cardiology and Therapy. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2016 | 26/09/2019 | Yes | No |
| Results article | results | 01/06/2020 | 03/02/2020 | Yes | No |
Editorial Notes
03/02/2020: Publication reference added.
NHW 02/10/2019: Trial’s existence confirmed by Interuniversity Ethical Committee
