Handled Echocardiography and Chronic Heart Failure

NCT ID: NCT01365325

Last Updated: 2011-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2010-12-31

Brief Summary

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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

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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

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Chronic Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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handled echocardiography

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

Group Type EXPERIMENTAL

handled echocardiography in home monitoring program

Intervention Type OTHER

home monitoring with clinical evaluations and ECG every three months and echocardiography examinations at the 6th, 12th and 18th month

home monitoring program

home monitoring care program based on clinical and electrocardiographic evaluations

Group Type ACTIVE_COMPARATOR

ecg and clinical evaluation in home monitoring program

Intervention Type OTHER

home monitoring with clinical evaluations and ECG every three months

Interventions

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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

Intervention Type OTHER

ecg and clinical evaluation in home monitoring program

home monitoring with clinical evaluations and ECG every three months

Intervention Type OTHER

Other Intervention Names

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Handled echocardiography home monitoring with clinical evaluations and ECG

Eligibility Criteria

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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
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federico II University

OTHER

Sponsor Role lead

Responsible Party

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Federico II University

Principal Investigators

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Ugo Oliviero, MD

Role: PRINCIPAL_INVESTIGATOR

Federico II University

Locations

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Federico II University

Naples, , Italy

Site Status

Countries

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Italy

Other Identifiers

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228/08

Identifier Type: -

Identifier Source: org_study_id

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