Handled Echocardiography and Chronic Heart Failure
Management of Chronic Heart Failure: Role of the Handled Echocardiography in Home Monitoring Care Programs
1 other identifier
interventional
118
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2009
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 27, 2011
CompletedFirst Posted
Study publicly available on registry
June 3, 2011
CompletedJune 3, 2011
December 1, 2010
1.5 years
May 27, 2011
June 1, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Rehospitalization for worsening of heart failure symptoms and/or for the appearance of major vascular events
18 months
Secondary Outcomes (3)
Home treated major vascular events
18 months
Cardiovascular death
18 months
Composite end point death + rehospitalization
18 months
Study Arms (2)
handled echocardiography
EXPERIMENTALhome monitoring care program based on clinical and electrocardiographic evaluations and periodical handled echocardiographic examinations
home monitoring program
ACTIVE COMPARATORhome monitoring care program based on clinical and electrocardiographic evaluations
Interventions
home monitoring with clinical evaluations and ECG every three months and echocardiography examinations at the 6th, 12th and 18th month
home monitoring with clinical evaluations and ECG every three months
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients who were waiting for cardiac surgery or patients who had undergone a cardiac operation within three months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Federico II University
Naples, 80131, Italy
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Ugo Oliviero, MD
Federico II University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 27, 2011
First Posted
June 3, 2011
Study Start
January 1, 2009
Primary Completion
July 1, 2010
Study Completion
December 1, 2010
Last Updated
June 3, 2011
Record last verified: 2010-12