Handled Echocardiography and Chronic Heart Failure

Federico II University118 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

118

Conditions

Chronic Heart Failure

Interventions

handled echocardiography in home monitoring programOTHER

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 programOTHER

home monitoring with clinical evaluations and ECG every three months

Eligibility

Sex: ALLMin age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Federico II University

Naples, Italy

Outcomes

Primary Outcomes

Rehospitalization for worsening of heart failure symptoms and/or for the appearance of major vascular events

Time frame: 18 months

Secondary Outcomes

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

Time frame: 18 months

Cardiovascular death

Time frame: 18 months

Composite end point death + rehospitalization

Time frame: 18 months

Data from ClinicalTrials.gov

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