Plain English Summary
Background and study aims?
Despite best treatment for high blood pressure, blood pressure (BP) control is achieved in less than one third of the patients. The main reason is the low adherence of patients to the treatment and lack of awareness about high blood pressure and its consequences. The need to take many pills, several times a day, for a long time and possible side effects of drugs significantly reduce the number of patients who are treated continuously. Less effective treatment is also due to lack of simple step-by-step administration of a particular combination of drugs (Perindopril and Amlodipine) that can be effective in decreasing blood pressure, with low probability of side effects and the possibility of a single dose daily. Effective treatment can be reached when doctors make home visits to measure patients blood pressure. Self-monitoring of blood pressure by the patients between doctor visits also promotes adherence to treatment. The objective of this study is to see how good such a stepwise administration of treatment is along with BP monitoring at home and educating patients to keep to treatment.
Who can participate?
Patients with blood pressure more than 160/100mmHg if they have not been treated or more than 140/90mmHg if they have received therapy with one, two or three antihypertensive drugs can participate in the study.
What does the study involve?
The study includes patients aged 35 to 70, with high blood pressure and who are in the outpatient treatment. Patients visit the doctor for over 6 months. In the first visit, the doctor evaluates the patients demographic information, medical history, risk factors, information about the treatment conducted, blood pressure, heart rate and adherence to treatment by questionnaire. In addition, every participant of the study receives recommendations to alter their lifestyle and instructions for measuring blood pressure at home. The doctor conducts screening and decides on the inclusion of the patient in the trial, If included, their current treatment is stopped depending on the condition of the patient. The doctor chooses the drug combination (perindopril/amlodipine) according to initial blood pressure and presence of other diseases, where the patient may require an increased dose. In the second visit, doctor changes the therapy according to the results achieved by previous treatment. The effectiveness of the treatment using this combination of drugs is assessed using various parameters.
What are the possible benefits and risks of participating?
There is no immediate direct benefit to those taking part. All participants receive an additional teaching material regarding the procedure to be performed. Information obtained from this study may be helpful in future. By taking part in this study there are no risks of physical injury or harm to the participants.
Where is the study run from?
The PERFECT-BP study has been set up by the Cardiovascular Surgeons Association (Ukraine) and Kiev City Therapeutic Society (Ukraine).
When is study starting and how long is it expected to run for?
The study started in March 2012 and will run for one year or until the required number of patients have been recruited and evaluated
Who is funding the study?
Cardiovascular Surgeons Association and Kiev City therapeutic Society. Kiev, Ukraine
Who is the main contact
Professor Amosova Ekateryna
kateryna.amosova@gmail.com
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Open clinical program implemented to optimize efficacy of blood pressure control and patient's compliance in every day out-patient cardiological practice
Acronym
PERFECT-BP
Study hypothesis
Evaluate efficacy and tolerability of unified step-by-step antihypertensive therapy based on fixed combination of perindopril arginine/amlodipine with added indapamide retard in combination with correct home blood pressure monitoring and the education program for hypertensive patients in out-patient cardiological practice.
Ethics approval
Ukraine Central Ethics Committee, 02.03.2012, ref: no. 5.12 310/KE
Study design
Single center prospective open study
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
GP practices
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Arterial hypertension
Intervention
If the patient previously was not treated, he is administered fixed combination of perindopril/amlodipine (Bi-Prestarium) in dose of 5/5 mg, 5/10 or 10/5 mg once per day. The doctor chooses the dose according to baseline blood pressure and comorbidity in patient who may require increased doses of Perindopril and Amlodipine. If the patient was treated before the doctor prescribes therapy according to its own judgment based on the algorithm of treatment that is detailed below. Prescription of drugs on each successive step is possible only after the prescription of treatment on the previous steps.
Step 1: prescribing Bi-Prestarium one tablet per day
Step 2: increasing dose of Bi-Prestarium to maximum tolerated
Step 3: prescribing indapamide retard (Arifon Retard) once per day
Step 4: prescribing Spironolactone 25 mg twice per day
Step 5: prescribing Moxonidine in dose of 0.2 mg to 0.6 mg per day or Doxazosin 4-8 mg per day
At the first visit the patient is prescribed also aspirin and statin on medical indications.
Second and subsequent visit: the doctor changes the therapy according to the results achieved by previous treatment by its decision based on the treatment algorithm that was discussed above.
Prescribing of drugs on each successive step is possible only after reaching the maximum tolerated dose of Bi-Prestarium and having ordered the treatment on previous steps.
Overall treatment for one patient is 12 months.
In the course of trial the deviation from the established dosage regimen scheme is not allowed. In the case where in the opinion of a physician there is a need to deviate from the appointed regimen scheme the patient should be excluded from the trial and substituted with another one.
Intervention type
Drug
Phase
Not Applicable
Drug names
Perindopril , Amlodipine, indapamide
Primary outcome measures
1. Percentage of the patients who had achieved BP (less than 140/90 mm Hg) and for diabetes pts . BP<135/85 mm Hg
2. Percentage of the patients who had achieved home BP (less than 135/85 mm Hg)
Secondary outcome measures
1.Compare the achievement of target office blood pressure with a frequency achievement of target home BP, according to an independent measurement of blood pressure
2. Frequency of achieving BP control (<135/80 mm Hg.) for self-measurement of home blood pressure
3. Dynamics of office SBP and DBP reduction
4. Assessment of tolerability: dynamics of the patient's side effect
5. Assessment of adherence: Dynamics of the patient`s compliance - patient compliance assessed by questionnaire test X. Girerd
Sub study
1.Dynamic of average daytime and nighttime SBP and DBP assessed with ABPM
2. Dynamics of central systolic blood pressure and central pulse pressure dynamics
3. Dynamic of echocardiography indexes
4. Dynamics of pulse wave velocity
Overall trial start date
10/03/2012
Overall trial end date
01/04/2013
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patient with arterial hypertension
2. Men and women aged 35-70 years
3. Not yet treated with BP>160/100 <200/120 mm Hg
4. Uncontrolled with monotherapy (SBP>140/90 <200/120 mm Hg)
5. Uncontrolled with combination of 2 antihypertensive (SBP>140/90 <200/120 mm Hg)
6. Uncontrolled with combination of 3 antihypertensive (SBP>140/90 <200/120 mm Hg)
*patients should stop previous treatment at the day of inclusion and be switched to fixed combination of perindopril arginine/amlodipine Β-blocker allowed for CAD patients but dose of Β-blockers should be stable during all period of study.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
520
Participant exclusion criteria
1. Cerebrovascular events within 3 last month of anamnesis
2. Myocardial infarction within 6 last of anamnesis
3. Valvular heart disease
4. Uncontrolled arrhythmias
5. Pregnant or lactating woman
6. COPD during exasperation
7. Contraindications linked to ACEi or CCBs, or its intolerance (including allergic reaction linked to these drugs)
8. II types diabetes ( fasting glycaemia>7 mmol/l)
9. Renal failure (GFR<60 ml/min)
10. Renal artery stenosis, hyperthyroidism
11. Oncology disease
12. Mental disease, alcoholism,
13. Liver failure (ALT, AST)
14. Heart failure (NYHA II and more)
15. BP>200/120 mm Hg
Recruitment start date
10/03/2012
Recruitment end date
01/04/2013
Locations
Countries of recruitment
Ukraine
Trial participating centre
13 Shevchenko boulevard, Bogomolets National Medical University, Department of Internal Medicine #2
Kiev
01004
Ukraine
Sponsor information
Organisation
Kiev City Heart Centre (Ukraine)
Sponsor details
Bratislava
5a
Kiev
02 660
Ukraine
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Other
Funder name
Cardiovascular surgeons Association (Ukraine)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Kiev city therapeutic society (Ukraine)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary