Effectiveness and Patient Self-assessed Compliance of Blood Pressure Treatment With Tarka® Fixed Combination in Patients With Essential Hypertension

Study Overview
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Brief Summary
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The fixed combination of verapamil SR/trandolapril (Tarka®) is an effective, well-tolerated therapy for the treatment of essential hypertension in those who require more than one agent to achieve optimal blood pressure (BP) control. The endpoint is compliance with Tarka® treatment by number/percentage of patients continued on fixed combination Tarka therapy after six months. This Post Marketing Observational Study will be conducted in a prospective, single-arm, single-country, multicenter format. The investigational sites will be the cardiologists, the doctors of internal medicine and general practicians. Since this will be a Post Marketing Observational Study, Tarka® will be prescribed in usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as the local guidelines.

Detailed Description
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Follow-up of patients enables 4 patient visits during this period. For these reasons, the most likely visits are defined as Inclusion visit at which treatment with Tarka® is to be initiated, and then Follow-up visit Week 4-6, Follow-up visit Month 3  and Follow-up visit Month 6, although dates will depend only on the decision of the physician. For these reasons, the most likely visits are defined as S/V (Screening Visit), F1 (Follow-up 1), F2 (Follow-up 2), F3 (Follow-up 3). The end point is compliance with Tarka® treatment by number/percentage of patients continued on fixed combination Tarka therapy after six months.

Official Title
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Effectiveness and Patient Self-assessed Compliance of Blood Pressure Treatment With VerapamilSR/ Trandolapril Fixed Combination (Tarka®) in Patients With Essential Hypertension in Routine Clinical Practice

Conditions
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Essential Hypertension

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men, women more than 18 years Patients with uncontrolled essential hypertension eligible to Tarka treatment according to local label (BP ≥ 140/90 mmHg) Patients providing oral informed consent (including consent of their medical data to be used for a Post Marketing Observational Study) and cooperating with physician Patients who never received Tarka® in the past Patients whom Tarka® will be prescribed according to the labelled indication and dose Exclusion Criteria: Patients contraindicated for treatment of Tarka® according to the local Summary of Product Characteristics (SmPC): Hypersensitive to the active substances or to any of the inactive ingredients With cardiogenic shock With second and third degree atrioventricular block - except in patients with a functioning artificial pacemaker With sick sinus syndrome - except in patients with a functioning artificial pacemaker With atrial fibrillation/flutter and concomitant Wolff-Parkinson-White syndrome With existing history of angioedema associated with administration of an ACE inhibitor With severe renal (creatinine clearance < 10 ml/min) or severe liver impairment (cirrhosis with ascites) Pregnant women, women of childbearing potential who are unwilling to use contraception Lactating women Patients who have participated in clinical studies within the last month or who are currently enrolled in clinical studies Patients currently treated with other fixed antihypertensive combination

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Czech patients with essential hypertension<br>Czech hypertensive patients (women and men) with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg who can be treated with fixed-combination Tarka®. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance With Tarka Treatment, All Participants and by Gender. | Participants were asked how many doses of Tarka they had missed after three months of treatment. | Month 3 Visit | 
| Compliance With Tarka Treatment, All Participants and by Gender. | Participants were asked how many doses of Tarka they had missed since their previous visit. | Month 6 Visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | The mean (average) change in participants' systolic blood pressure and diastolic blood pressure from the baseline visit to the Month 6 visit. | Baseline to Month 6 Visit | 
| Percentage of Patients Achieving Blood Pressure < 140/90 mmHg | The percentage of patients who had achieved blood pressure less than 140/90 mmHg after three months of treatment. | Month 3 Visit | 
| Percentage of Patients Achieving Blood Pressure < 140/90 mmHg | The percentage of patients who had achieved blood pressure less than 140/90 mmHg after six months of treatment. | Month 6 Visit | 
| Number and Type of Antihypertensive Drugs Added to Fixed Combination Tarka to Reach Blood Pressure Goal | The number of participants at the Month 3 visit who were taking other antihypertensive drugs in addition to their Tarka treatment to reach blood a pressure goal of less than 140/90 mmHg. The number of participants taking each type of additional drug is summarized. | Month 3 Visit | 
| Number and Type of Antihypertensive Drugs Added to Fixed Combination Tarka to Reach Blood Pressure Goal | The number of participants at the Month 6 visit who were taking other antihypertensive drugs in addition to their Tarka treatment to reach a blood pressure goal of less than 140/90 mmHg. The number of participants taking each type of additional drug is summarized. | Month 6 Visit | 
| Adverse Events Leading to Study Discontinuation | The number of participants who discontinued from the study due to an adverse event and reported event descriptions are summarized. | Baseline to Month 6 Visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Essential hypertension