Handled Echocardiography and Chronic Heart Failure

Not Applicable

Completed

• Conditions: Chronic Heart Failure
• Interventions: Other: handled echocardiography in home monitoring program; Other: ecg and clinical evaluation in home monitoring program

• Registration Number: NCT01365325
• Lead Sponsor: Federico II University

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.

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2010-07
• Status Verified: 2010-12
• Study Completion: 2010-12
• Study First Submitted: 2011-05-27
• Study First Submitted QC: 2011-06-01
• Last Update Submitted: 2011-06-01
• Study First Posted: 2011-06-03
• Last Update Posted: 2011-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
handled echocardiography	handled echocardiography in home monitoring program	home monitoring care program based on clinical and electrocardiographic evaluations and periodical handled echocardiographic examinations
home monitoring program	ecg and clinical evaluation in home monitoring program	home monitoring care program based on clinical and electrocardiographic evaluations

Primary Outcome Measures

Name	Time	Method
Rehospitalization for worsening of heart failure symptoms and/or for the appearance of major vascular events	18 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Federico II University; 🇮🇹 Naples, Italy