Text Size

Handled Echocardiography and Chronic Heart Failure

This study has been completed.
Sponsor:
Information provided by:
Federico II University
ClinicalTrials.gov Identifier:
NCT01365325
First received: May 27, 2011
Last updated: June 1, 2011
Last verified: December 2010
History of Changes
  Purpose

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.


Condition Intervention
Chronic Heart Failure
 Other: handled echocardiography in home monitoring program
Other: ecg and clinical evaluation in home monitoring program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Management of Chronic Heart Failure: Role of the Handled Echocardiography in Home Monitoring Care Programs

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Further study details as provided by Federico II University:

Primary Outcome Measures:
  • Rehospitalization for worsening of heart failure symptoms and/or for the appearance of major vascular events [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Home treated major vascular events [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    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

  • Cardiovascular death [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  • Composite end point death + rehospitalization [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Enrollment: 118
Study Start Date: January 2009
Study Completion Date: December 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: home monitoring with clinical evaluations and ECG

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.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01365325

Locations
Italy
Federico II University
Naples, Italy, 80131
Sponsors and Collaborators
Federico II University
Investigators
Principal Investigator: Ugo Oliviero, MD Federico II University
  More Information

No publications provided

Responsible Party: Ugo Oliviero, Federico II University
ClinicalTrials.gov Identifier: NCT01365325     History of Changes
Other Study ID Numbers: 228/08
Study First Received: May 27, 2011
Last Updated: June 1, 2011
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013