Handled Echocardiography and Chronic Heart Failure

Chronic Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01365325
• Other study ID #: 228/08
• Status: Completed
• Phase: N/A
• First received: May 27, 2011
• Last updated: June 1, 2011
• Start date: January 2009
• Est. completion date: December 2010

Study information

• Verified date: December 2010
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: December 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Intervention

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
• ecg and clinical evaluation in home monitoring program
home monitoring with clinical evaluations and ECG every three months

Locations

Country	Name	City	State
Italy	Federico II University	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rehospitalization for worsening of heart failure symptoms and/or for the appearance of major vascular events		18 months	Yes
Secondary	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	Yes
Secondary	Cardiovascular death		18 months	Yes
Secondary	Composite end point death + rehospitalization		18 months	Yes