Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Prof Maria Glezer
ORCID ID
http://orcid.org/0000-0002-0995-1924
Contact details
Department of Preventive and Emergency Cardiology
Sechenov First Moscow State Medical University. 2-4 Bolshaya Pirogovskaya st.
Moscow
119991
Russian Federation
+7(985)7630420
rektorat@sechenov.ru
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
IC4-06597-011-RUS
Study information
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
Acronym
FORSAGE
Study hypothesis
Physician and patient training and use of single-pill combination of perindopril/indapamide may improve antihypertensive efficacy and treatment compliance
Ethics approval
Approved 20/06/2014, Interuniversity Ethical Committee (119002, 37, bld. 2, Gagarinsky Lane, Moscow, tel. +7 (916) 2607664), ref: 06-14
Study design
Non-interventional educational multicenter open-label study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Condition
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
Phase
Drug names
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 trial start date
12/04/2014
Overall trial end date
18/04/2016
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
2000
Total final enrolment
1969
Participant 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
Recruitment start date
01/11/2014
Recruitment end date
28/02/2015
Locations
Countries of recruitment
Russian Federation
Trial participating centre
Department of Preventive and Emergency Cardiology, Sechenov First Moscow State Medical University
2-4 Bolshaya Pirogovskaya str.
Moscow
119991
Russian Federation
Sponsor information
Organisation
JBC ‘Servier’
Sponsor details
bld.7
Lesnaja str.
Moscow
125196
Russian Federation
+7(495) 937-0700
natalya.logunova@servier.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Servier
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
We are planning the publication in the journal Cardiology and Therapy.
IPD sharing statement:
The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository
Intention to publish date
31/03/2020
Participant level data
Stored in repository
Basic results (scientific)
Publication list
2016 results in https://www.ncbi.nlm.nih.gov/pubmed/28294726 (added 26/09/2019)
2020 results in https://www.ncbi.nlm.nih.gov/pubmed/32008207 (added 03/02/2020)