Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01541566
Other study ID # TELEBPMET
Secondary ID
Status Completed
Phase N/A
First received February 17, 2012
Last updated February 25, 2016
Start date November 2007
Est. completion date December 2010

Study information

Verified date February 2016
Source Italian Institute of Telemedicine
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 254
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 74 Years
Eligibility 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

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Locations

Country Name City State
Italy Policlinico Universitario Bari
Italy Spedali Civili Brescia
Italy Ospedale di Broni Broni Pavia
Italy Fondazione Maugeri Lumezzane Brescia
Italy Istituto Auxologico Italiano Milano
Italy Policlinico Universitario Padova
Italy Fondazione Maugeri Pavia
Italy Ospedale Santa Chiara Pisa
Italy Ospedale Fatebenefratelli Roma
Italy Casa di Cura Tortorella Salerno
Italy Ospedale San Felice a Cancello San Felice a Cancello Caserta
Italy Ospedale di Circolo Varese

Sponsors (3)

Lead Sponsor Collaborator
Italian Institute of Telemedicine Bracco Corporate, Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of subjects with average day-time ambulatory blood pressure <135/85 mmHg 6 months No
Primary Percentage of subjects with average day-time ambulatory blood pressure <135/85 mmHg 12 months No
Secondary Psychological determinats of therapeutic adherence 6 months No
Secondary Percentage of subjects with office blood pressure <140/90 mmHg 6 months No
Secondary Changes in home blood pressure 6 months No
Secondary Number of additional medical visits 6 months No
Secondary Direct costs of intervention 6 months No
Secondary Number of antihypertensive drugs 6 months No
Secondary Level of cardiovascular risk by ESC Heart Score and Framingham 6 months No
Secondary Target organ damage and outcomes 6 months No
Secondary Percentage of patients with metabolic syndrome 6 months No
Secondary Psychological determinats of therapeutic adherence 12 months No
Secondary Percentage of subjects with office blood pressure <140/90 mmHg 12 months No
Secondary Changes in home blood pressure 12 months No
Secondary Number of additional medical visits 12 months No
Secondary Direct costs of intervention 12 months No
Secondary Number of antihypertensive drugs 12 months No
Secondary Level of cardiovascular risk by ESC Heart Score and Framingham 12 months No
Secondary Target organ damage and outcomes 12 months No
Secondary Percentage of patients with metabolic syndrome 12 months No
Secondary Percentage of subjects with home blood pressure <135/85 mmHg 6 months No
Secondary Percentage of subjects with home blood pressure <135/85 mmHg 12 months No
Secondary Changes in 24h blood pressure 6 months No
Secondary Changes in 24h blood pressure 12 months No
Secondary Changes in office blood pressure 6 months No
Secondary Changes in office blood pressure 12 months No
Secondary Adherence to treatment 6 months No
Secondary Adherence to treatment 12 months No
See also
  Status Clinical Trial Phase
Recruiting NCT04635202 - Effect of Elliptical Training on Metabolic Homeostasis in Metabolic Syndrome N/A
Completed NCT04053686 - An Intervention to Reduce Prolonged Sitting in Police Staff N/A
Completed NCT05343858 - Pilot Study to Evaluate the Effect of Two Microalgae Consumption on Metabolic Syndrome N/A
Active, not recruiting NCT05891834 - Study of INV-202 in Patients With Obesity and Metabolic Syndrome Phase 2
Recruiting NCT05040958 - Carotid Atherosclerotic Plaque Load and Neck Circumference
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Active, not recruiting NCT02500147 - Metformin for Ectopic Fat Deposition and Metabolic Markers in Polycystic Ovary Syndrome (PCOS) Phase 4
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Recruiting NCT05972564 - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function Phase 1/Phase 2
Completed NCT03289897 - Non-invasive Rapid Assessment of NAFLD Using Magnetic Resonance Imaging With LiverMultiScan N/A
Recruiting NCT05956886 - Sleep Chatbot Intervention for Emerging Black/African American Adults N/A
Completed NCT06057896 - Effects of Combined Natural Molecules on Metabolic Syndrome in Menopausal Women
Active, not recruiting NCT03613740 - Effect of Fucoxanthin on the Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion Phase 2
Completed NCT04498455 - Study of a Prebiotic Supplement to Mitigate Excessive Weight Gain Among Physicians in Residency Phase 4
Completed NCT05688917 - Green Coffee Effect on Metabolic Syndrome N/A
Completed NCT04117802 - Effects of Maple Syrup on Gut Microbiota Diversity and Metabolic Syndrome N/A
Completed NCT03697382 - Effect of Daily Steps on Fat Metabolism N/A
Completed NCT03241121 - Study of Eating Patterns With a Smartphone App and the Effects of Time Restricted Feeding in the Metabolic Syndrome N/A
Completed NCT04509206 - Virtual Teaching Kitchen N/A
Completed NCT05124847 - TREating Pediatric Obesity N/A