The value of INnovative ICT guided Disease Management combined with Telemonitoring in OUt patient clinics for Chronic Heart failure patients

Completed

Conditions: Chronic Heart Failure
10019280

Registration Number: NL-OMON33608

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 450

Inclusion Criteria

•Patients are diagnosed with systolic heart failure (NYHA III- IV)
•Evidence for structural underlying heart disease
•Patients are intravenously treated with diuretics during their hospitalisation
•Documented Ejection Fraction <= 40% in the previous 3 months
•Patients have to be older than >= 18 years
•Patients have to be able to understand content of and willing to provide informed consent

Exclusion Criteria

•Patients <= 18 years
•History of myocardial infarction in previous 1 month
•Life expectation < 1 year
•History of valve replacement or surgery in the previous 6 months
•Have undergone cardiac invasive intervention the last 6 months (PTCA, CABG, HTX, valve replacement) or planned to have such a procedure in the following 3 months.
•Evaluation for heart transplantation prior or during the study
•The inability of patients to fill out questionnaires
•The inability of patients to use Telemedicine devices at home
•Participation at another clinical intervention trial

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint of the study is a composite score made up of weighted values<br /><br>for;<br /><br>•Death from any cause;<br /><br>•First readmission for heart failure, defined as an overnight stay in a<br /><br>hospital (with different dates for admission and discharge) for progression of<br /><br>heart failure or directly related to heart failure;<br /><br>•Change in quality of life at end of study compared to baseline, assessed by<br /><br>the Minnesota Living with Heart Failure Questionnaire. </p><br>

Secondary Outcome Measures