Handled Echocardiography and Chronic Heart Failure

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Heart Failure
• Intervention / Treatment: Other: handled echocardiography in home monitoring program; Other: ecg and clinical evaluation in home monitoring program

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 Type: Interventional
• Enrollment (Actual): 118
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Naples, Italy, 80131
    • Federico II University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: handled echocardiography; home monitoring care program based on clinical and electrocardiographic evaluations and periodical handled echocardiographic examinations	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 Names: Handled echocardiography
Active Comparator: home monitoring program; home monitoring care program based on clinical and electrocardiographic evaluations	Other: ecg and clinical evaluation in home monitoring program; home monitoring with clinical evaluations and ECG every three months; Other Names: home monitoring with clinical evaluations and ECG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rehospitalization for worsening of heart failure symptoms and/or for the appearance of major vascular events	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Home treated major vascular events	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	18 months
Cardiovascular death		18 months
Composite end point death + rehospitalization		18 months

Collaborators and Investigators

• Sponsor: Federico II University
• Investigators: Principal Investigator: Ugo Oliviero, MD, Federico II University

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: May 27, 2011
• First Submitted That Met QC Criteria: June 1, 2011
• First Posted (Estimate): June 3, 2011

Study Record Updates

• Last Update Posted (Estimate): June 3, 2011
• Last Update Submitted That Met QC Criteria: June 1, 2011
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 228/08