Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
118 participants
INTERVENTIONAL
2009-01-31
2010-12-31
Brief Summary
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Detailed Description
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The events occurring during the 18 month follow up and the results of the final echocardiography performed in all the patients will be transmitted to and evaluated by an independent observer, unaware of the features of the follow up. At the end of the trial, the randomization code will be opened and the events will be ascribed to the two groups. The primary end point is rehospitalization for worsening of heart failure symptoms and/or for the appearance of major vascular events during the 18 months follow up. Secondary end points include home treated vascular events, cardiovascular death and the composite end point death + rehospitalization.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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handled echocardiography
home monitoring care program based on clinical and electrocardiographic evaluations and periodical handled echocardiographic examinations
handled echocardiography in home monitoring program
home monitoring with clinical evaluations and ECG every three months and echocardiography examinations at the 6th, 12th and 18th month
home monitoring program
home monitoring care program based on clinical and electrocardiographic evaluations
ecg and clinical evaluation in home monitoring program
home monitoring with clinical evaluations and ECG every three months
Interventions
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handled echocardiography in home monitoring program
home monitoring with clinical evaluations and ECG every three months and echocardiography examinations at the 6th, 12th and 18th month
ecg and clinical evaluation in home monitoring program
home monitoring with clinical evaluations and ECG every three months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* At least once hospitalization during the last year for worsening of clinical symptoms or for the appearance of acute cardiovascular events
* Patients who cannot easily reach the pertaining Sanitary District for different reasons (i.e. the presence of architectural barriers, the absence of a lift, a too great distance between home and Sanitary District without someone helping)
* age ≥ 70 years
* written informed consent
Exclusion Criteria
70 Years
ALL
No
Sponsors
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Federico II University
OTHER
Responsible Party
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Federico II University
Principal Investigators
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Ugo Oliviero, MD
Role: PRINCIPAL_INVESTIGATOR
Federico II University
Locations
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Federico II University
Naples, , Italy
Countries
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Other Identifiers
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228/08
Identifier Type: -
Identifier Source: org_study_id
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