Handled Echocardiography and Chronic Heart Failure

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Management of Chronic Heart Failure: Role of the Handled Echocardiography in Home Monitoring Care Programs

Conditions
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Chronic Heart Failure

Intervention / Treatment
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* Other: handled echocardiography in home monitoring program
* Other: ecg and clinical evaluation in home monitoring program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic Heart Failure in functional class NYHA III 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: Patients who were waiting for cardiac surgery or patients who had undergone a cardiac operation within three months

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: handled echocardiography<br>home monitoring care program based on clinical and electrocardiographic evaluations and periodical handled echocardiographic examinations | Other: handled echocardiography in home monitoring program<br>* home monitoring with clinical evaluations and ECG every three months and echocardiography examinations at the 6th, 12th and 18th month<br>* Other names: Handled echocardiography;|
| Active Comparator: home monitoring program<br>home monitoring care program based on clinical and electrocardiographic evaluations | Other: ecg and clinical evaluation in home monitoring program<br>* home monitoring with clinical evaluations and ECG every three months<br>* Other names: home monitoring with clinical evaluations and ECG;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rehospitalization for worsening of heart failure symptoms and/or for the appearance of major vascular events |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 18 months | 
| Composite end point death + rehospitalization |  | 18 months |