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

Italian Institute of Telemedicine254 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

254

Conditions

Arterial Hypertension Metabolic Syndrome

Eligibility

Sex: ALLMin age: 18 YearsMax age: 74 Years

Medical Language ↔ Plain English

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

Locations (12)

Policlinico Universitario

Bari, Bari, Italy

Spedali Civili

Brescia, Brescia, Italy

Fondazione Maugeri

Lumezzane, Brescia, Italy

Ospedale San Felice a Cancello

San Felice A Cancello, Caserta, Italy

Istituto Auxologico Italiano

Milan, Milano, Italy

Policlinico Universitario

Padova, Padova, Italy

Ospedale di Broni

Broni, Pavia, Italy

Fondazione Maugeri

Pavia, Pavia, Italy

Ospedale Santa Chiara

Pisa, Pisa, Italy

Ospedale Fatebenefratelli

Roma, Roma, Italy

...and 2 more locations

Outcomes

Primary Outcomes

Percentage of subjects with average day-time ambulatory blood pressure <135/85 mmHg

Time frame: 6 months

Percentage of subjects with average day-time ambulatory blood pressure <135/85 mmHg

Time frame: 12 months

Secondary Outcomes

Psychological determinats of therapeutic adherence

Time frame: 6 months

Percentage of subjects with office blood pressure <140/90 mmHg

Time frame: 6 months

Changes in home blood pressure

Time frame: 6 months

Number of additional medical visits

Time frame: 6 months

Direct costs of intervention

Time frame: 6 months

Number of antihypertensive drugs

Time frame: 6 months

Level of cardiovascular risk by ESC Heart Score and Framingham

Time frame: 6 months

Target organ damage and outcomes

Time frame: 6 months

Percentage of patients with metabolic syndrome

Time frame: 6 months

Psychological determinats of therapeutic adherence

Time frame: 12 months

Percentage of subjects with office blood pressure <140/90 mmHg

Time frame: 12 months

Changes in home blood pressure

Time frame: 12 months

Number of additional medical visits

Time frame: 12 months

Direct costs of intervention

Time frame: 12 months

Number of antihypertensive drugs

Time frame: 12 months

Level of cardiovascular risk by ESC Heart Score and Framingham

Time frame: 12 months

Target organ damage and outcomes

Time frame: 12 months

Percentage of patients with metabolic syndrome

Time frame: 12 months

Percentage of subjects with home blood pressure <135/85 mmHg

Time frame: 6 months

Percentage of subjects with home blood pressure <135/85 mmHg

Time frame: 12 months

Changes in 24h blood pressure

Time frame: 6 months

Changes in 24h blood pressure

Time frame: 12 months

Changes in office blood pressure

Time frame: 6 months

Changes in office blood pressure

Time frame: 12 months

Adherence to treatment

Time frame: 6 months

Adherence to treatment

Time frame: 12 months