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NCT Number: NCT01541566

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

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.

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Key information

Conditions

Arterial Hypertension Cardiovascular Diseases Glucose Metabolism Disorders Hyperinsulinism Hypertension Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Policlinico Universitario, Bari, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: 6 months

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

    Time frame: 12 months

Secondary outcomes

  1. Psychological determinats of therapeutic adherence

    Time frame: 6 months

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

    Time frame: 6 months

  3. Changes in home blood pressure

    Time frame: 6 months

  4. Number of additional medical visits

    Time frame: 6 months

  5. Direct costs of intervention

    Time frame: 6 months

  6. Number of antihypertensive drugs

    Time frame: 6 months

  7. Level of cardiovascular risk by ESC Heart Score and Framingham

    Time frame: 6 months

  8. Target organ damage and outcomes

    Time frame: 6 months

  9. Percentage of patients with metabolic syndrome

    Time frame: 6 months

  10. Psychological determinats of therapeutic adherence

    Time frame: 12 months

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

    Time frame: 12 months

  12. Changes in home blood pressure

    Time frame: 12 months

  13. Number of additional medical visits

    Time frame: 12 months

  14. Direct costs of intervention

    Time frame: 12 months

  15. Number of antihypertensive drugs

    Time frame: 12 months

  16. Level of cardiovascular risk by ESC Heart Score and Framingham

    Time frame: 12 months

  17. Target organ damage and outcomes

    Time frame: 12 months

  18. Percentage of patients with metabolic syndrome

    Time frame: 12 months

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

    Time frame: 6 months

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

    Time frame: 12 months

  21. Changes in 24h blood pressure

    Time frame: 6 months

  22. Changes in 24h blood pressure

    Time frame: 12 months

  23. Changes in office blood pressure

    Time frame: 6 months

  24. Changes in office blood pressure

    Time frame: 12 months

  25. Adherence to treatment

    Time frame: 6 months

  26. Adherence to treatment

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Italian Institute of Telemedicine

Other

Collaborators

  • Bracco Corporate
  • Istituto Auxologico Italiano

Registry information

Official study title

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

Acronym: TELEBPMET

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Mar 1, 2012
Registry last updated
Feb 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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