Chronic Heart Failure
Conditions
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.
Interventions
OTHERhandled 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
OTHERecg and clinical evaluation in home monitoring program
home monitoring with clinical evaluations and ECG every three months
Sponsors
Federico II University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rehospitalization for worsening of heart failure symptoms and/or for the appearance of major vascular events | 18 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Home treated major vascular events | 18 months | 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 | 18 months | — |
| Composite end point death + rehospitalization | 18 months | — |
Countries
Italy
Outcome results
None listed