NCT01365325

Handled Echocardiography and Chronic Heart Failure

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 118 (actual)
• Sponsor: Federico II University · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Heart Failure

Interventions

Type	Name	Description
OTHER	handled 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
OTHER	ecg and clinical evaluation in home monitoring program	home monitoring with clinical evaluations and ECG every three months

Timeline

• Start date: 2009-01-01
• Primary completion: 2010-07-01
• Completion: 2010-12-01
• First posted: 2011-06-03
• Last updated: 2011-06-03

Locations

1 site across 1 country: Italy