Handled Echocardiography and Chronic Heart Failure
Primary Purpose
Chronic Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
handled echocardiography in home monitoring program
ecg and clinical evaluation in home monitoring program
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Heart Failure
Eligibility Criteria
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
Sites / Locations
- Federico II University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
handled echocardiography
home monitoring program
Arm Description
home monitoring care program based on clinical and electrocardiographic evaluations and periodical handled echocardiographic examinations
home monitoring care program based on clinical and electrocardiographic evaluations
Outcomes
Primary Outcome Measures
Rehospitalization for worsening of heart failure symptoms and/or for the appearance of major vascular events
Secondary Outcome Measures
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
Cardiovascular death
Composite end point death + rehospitalization
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01365325
Brief Title
Handled Echocardiography and Chronic Heart Failure
Official Title
Management of Chronic Heart Failure: Role of the Handled Echocardiography in Home Monitoring Care Programs
Study Type
Interventional
2. Study Status
Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Federico II University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
118 (Actual)
8. Arms, Groups, and Interventions
Arm Title
handled echocardiography
Arm Type
Experimental
Arm Description
home monitoring care program based on clinical and electrocardiographic evaluations and periodical handled echocardiographic examinations
Arm Title
home monitoring program
Arm Type
Active Comparator
Arm Description
home monitoring care program based on clinical and electrocardiographic evaluations
Intervention Type
Other
Intervention Name(s)
handled echocardiography in home monitoring program
Other Intervention Name(s)
Handled echocardiography
Intervention Description
home monitoring with clinical evaluations and ECG every three months and echocardiography examinations at the 6th, 12th and 18th month
Intervention Type
Other
Intervention Name(s)
ecg and clinical evaluation in home monitoring program
Other Intervention Name(s)
home monitoring with clinical evaluations and ECG
Intervention Description
home monitoring with clinical evaluations and ECG every three months
Primary Outcome Measure Information:
Title
Rehospitalization for worsening of heart failure symptoms and/or for the appearance of major vascular events
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Home treated major vascular events
Description
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
Time Frame
18 months
Title
Cardiovascular death
Time Frame
18 months
Title
Composite end point death + rehospitalization
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ugo Oliviero, MD
Organizational Affiliation
Federico II University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federico II University
City
Naples
ZIP/Postal Code
80131
Country
Italy
12. IPD Sharing Statement
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Handled Echocardiography and Chronic Heart Failure
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