Blood Pressure Control and Compliance to Treatment in Hypertensive Patients With Metabolic Syndrome: a Study Based on Home Blood Pressure Telemonitoring and Assessment of Psychological Determinants

Study Overview
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Brief Summary
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The purpose of this study is to assess whether, in patients at high cardiovascular risk (hypertension with metabolic syndrome), long-term (1-year) blood pressure control is most effective when based on home blood pressure telemonitoring and on the feedback to the patient by the doctor between visits, or when based only on blood pressure determination during quarterly office visits.

Official Title
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Blood Pressure Control and Compliance to Treatment in Hypertensive Patients With Metabolic Syndrome: a Study Based on Home Blood Pressure Telemonitoring

Conditions
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Arterial Hypertension, Metabolic Syndrome

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Treated or untreated uncontrolled essential arterial hypertension (office systolic blood pressure >140 or diastolic >90 mmHg + day-time systolic blood pressure >135 or day-time diastolic blood pressure >85 mmHg) Metabolic syndrome (ATP III criteria) Exclusion Criteria: Secondary arterial hypertension Severe liver or kidney disease Immunological disease Cardiac arrhythmias

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 74 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 |
| --- | --- |
| Home blood pressure telemonitoring<br>Patients regularly monitoring their blood pressure at home with an electronic validated upper arm device, transmitting blood pressure values at monthly intervals to the doctors office through the Internet. | |
| Conventional blood pressure measurement<br>Blood pressure measured only in the doctor's office during quarterly visits, without regular home blood pressure monitoring. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects with average day-time ambulatory blood pressure <135/85 mmHg |  | 6 months | 
| Percentage of subjects with average day-time ambulatory blood pressure <135/85 mmHg |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychological determinats of therapeutic adherence |  | 6 months | 
| Percentage of subjects with office blood pressure <140/90 mmHg |  | 6 months | 
| Changes in home blood pressure |  | 6 months | 
| Number of additional medical visits |  | 6 months | 
| Direct costs of intervention |  | 6 months | 
| Number of antihypertensive drugs |  | 6 months | 
| Level of cardiovascular risk by ESC Heart Score and Framingham |  | 6 months | 
| Target organ damage and outcomes |  | 6 months | 
| Percentage of patients with metabolic syndrome |  | 6 months | 
| Psychological determinats of therapeutic adherence |  | 12 months | 
| Percentage of subjects with office blood pressure <140/90 mmHg |  | 12 months | 
| Changes in home blood pressure |  | 12 months | 
| Number of additional medical visits |  | 12 months | 
| Direct costs of intervention |  | 12 months | 
| Number of antihypertensive drugs |  | 12 months | 
| Level of cardiovascular risk by ESC Heart Score and Framingham |  | 12 months | 
| Target organ damage and outcomes |  | 12 months | 
| Percentage of patients with metabolic syndrome |  | 12 months | 
| Percentage of subjects with home blood pressure <135/85 mmHg |  | 6 months | 
| Percentage of subjects with home blood pressure <135/85 mmHg |  | 12 months | 
| Changes in 24h blood pressure |  | 6 months | 
| Changes in 24h blood pressure |  | 12 months | 
| Changes in office blood pressure |  | 6 months | 
| Changes in office blood pressure |  | 12 months | 
| Adherence to treatment |  | 6 months | 
| Adherence to treatment |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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arterial hypertension, metabolic syndrome, home blood pressure, ambulatory blood pressure, office blood pressure, telemedicine