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Completed

NCT Number: NCT01365325

Handled Echocardiography and Chronic Heart Failure

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.

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Key information

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federico II University

Naples, 80131, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

handled echocardiography in home monitoring program

Other

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

Other names: Handled echocardiography

ecg and clinical evaluation in home monitoring program

Other

home monitoring with clinical evaluations and ECG every three months

Other names: home monitoring with clinical evaluations and ECG

Primary outcomes

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

    Time frame: 18 months

Secondary outcomes

  1. Home treated major vascular events

    Time frame: 18 months

    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

  2. Cardiovascular death

    Time frame: 18 months

  3. Composite end point death + rehospitalization

    Time frame: 18 months

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 3, 2011
Registry last updated
Jun 3, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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