Federico II University
Naples, 80131, Italy
NCT Number: NCT01365325
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.
Looking for future studies?
Notify Me70 year and older
All sexes
Interventional
Not applicable
Naples, 80131, Italy
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
home monitoring with clinical evaluations and ECG every three months and echocardiography examinations at the 6th, 12th and 18th month
Other names: Handled echocardiography
home monitoring with clinical evaluations and ECG every three months
Other names: home monitoring with clinical evaluations and ECG
Time frame: 18 months
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
Time frame: 18 months
Time frame: 18 months
Federico II University
Other
Management of Chronic Heart Failure: Role of the Handled Echocardiography in Home Monitoring Care Programs
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.
Published trials that share one or more normalized conditions with this study.
NCT07697365
Cardiovascular Diseases, Chronic Heart Failure
Athens, Attica, Greece
View Trial DetailsNCT07599345
Chronic Heart Failure, Heart Failure With Reduced Ejection Fraction
Boston, Massachusetts, United States
View Trial DetailsNCT07599293
Chronic Heart Failure, Diabetes Mellitus
Boston, Massachusetts, United States
View Trial DetailsNCT06299826
Chronic Heart Failure
Alexander City, Alabama, United States
View Trial Details