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The aim of the study is to compare two different home monitoring care programs in patients with chronic heart failure in functional class NYHA III, one of them based on clinical and electrocardiographic evaluations, the other one using also periodical handled echocardiographic examinations.
Randomized, blinded, controlled, monocentric study comparing two different home monitoring care programs in patients with chronic heart failure in functional class NYHA III, one of them based on clinical and electrocardiographic evaluations every three months, the other one using also periodical handheld echocardiographic examinations at the 6th, 12th and 18th month.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| handled echocardiography | Experimental | home monitoring care program based on clinical and electrocardiographic evaluations and periodical handled echocardiographic examinations |
|
| home monitoring program | Active Comparator | home monitoring care program based on clinical and electrocardiographic evaluations |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| handled echocardiography in home monitoring program | Other | home monitoring with clinical evaluations and ECG every three months and echocardiography examinations at the 6th, 12th and 18th month |
| Measure | Description | Time Frame |
|---|---|---|
| Rehospitalization for worsening of heart failure symptoms and/or for the appearance of major vascular events | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Home treated major vascular events | Number of Participants with major vascular events occurred during the 18 months follow up who did not go to the Hospital and were home treated | 18 months |
| Cardiovascular death |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ugo Oliviero, MD | Federico II University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federico II University | Naples | 80131 | Italy |
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| ID | Term |
|---|---|
| C062669 | epicatechin gallate |
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|
| ecg and clinical evaluation in home monitoring program | Other | home monitoring with clinical evaluations and ECG every three months |
|
|
| 18 months |
| Composite end point death + rehospitalization | 18 months |