Handled Echocardiography and Chronic Heart Failure

Federico II University

Status: Completed

Conditions: Chronic Heart Failure

Treatments: Other: handled echocardiography in home monitoring program; Other: ecg and clinical evaluation in home monitoring program

Study type: Interventional

Funder types: Other

Identifiers

NCT01365325

228/08

Details and patient eligibility

About

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.

Full 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.

Enrollment: 118 patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

118 participants in 2 patient groups

handled echocardiography

Experimental group

Description:

home monitoring care program based on clinical and electrocardiographic evaluations and periodical handled echocardiographic examinations

Treatment:

Other: handled echocardiography in home monitoring program

home monitoring program

Active Comparator group

Description:

home monitoring care program based on clinical and electrocardiographic evaluations

Treatment:

Other: ecg and clinical evaluation in home monitoring program