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Clinical Trials/NCT01541566
NCT01541566
Completed
Not Applicable

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

Italian Institute of Telemedicine10 sites in 1 country254 target enrollmentNovember 2007
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ConditionsArterial HypertensionMetabolic Syndrome

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Arterial Hypertension
Sponsor
Italian Institute of Telemedicine
Enrollment
254
Locations
10
Primary Endpoint
Percentage of subjects with average day-time ambulatory blood pressure <135/85 mmHg
Status
Completed
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
November 2007
End Date
December 2010
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Italian Institute of Telemedicine
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 12 months

Secondary Outcomes

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

Study Sites (10)

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