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Program to optimize the treatment compliance and blood pressure control in hypertensive patients in real cardiologist's practice

Open clinical program implemented to optimize efficacy of blood pressure control and patient's compliance in every day out-patient cardiological practice

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN75706523
Enrollment
520
Registered
2013-05-23
Start date
2012-03-10
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arterial hypertension Circulatory System Hypertension

Interventions

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

Sponsors

Kiev City Heart Centre (Ukraine)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patient with arterial hypertension 2. Men and women aged 35-70 years 3. Not yet treated with BP>160/100 140/90 140/90 140/90 <200/120 mm Hg) *patients should stop previous treatment at the day of inclusion and be switched to fixed combination of perindopril arginine/amlodipine ?-blocker allowed for CAD patients but dose of ?-blockers should be stable during all period of study.

Exclusion criteria

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 (GFR200/120 mm Hg

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Ukraine

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 4, 2026