Telemedical Interventional Management in Heart Failure II

Phase 3

• Conditions: I50; Heart failure

• Registration Number: DRKS00010239
• Lead Sponsor: Charité Campus Charité Mitte

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-01
• Study Completion: 2018-05-17
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 1571

Inclusion Criteria

1. chronic heart failure New York Heart Association (NYHA) class II or III; 2. echocardiographically determined left ventricular ejection fraction (LVEF) =45% or >45% + minimum 1 diuretic in permanent medicinal therapy;
3. hospitalization due to decompensated HF within the last 12months before randomization; 4. informed consent; 5. depression score (PHQ-9 <10)

Exclusion Criteria

Hospitalization within the last 7 days before randomization; Implanted cardiac assist system
Acute coronary syndrome within the last 7 days before randomization; High urgent listed for heart transplantation (HTx); Planned revascularization, Transcatheter Aortic Valve Implantation (TAVI), MitraClip and/or Cardiac Resynchronization Therapy (CRT)-implantation within the last 3 months before randomization
Revascularization and/or CRT-implantation within 28 days before randomization;
Known alcohol or drug abuse; Terminal renal insufficiency with hemodialysis;
Impairment or unwillingness to use the telemonitoring equipment (e.g. dementia, impaired self-determination, lacking ability to communicate); Existence of any disease reducing life expectancy to less than 1 year; Age <18 years; Pregnancy; Participation in other treatment studies or remote patient management programmes (register studies possible)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Days lost due to unplanned cardiovascular hospitalization or death (Follow-up for 365-days)

Secondary Outcome Measures

Name	Time	Method
Time Frame: 12 Months<br>a) all-cause mortality (time-to-event) <br>b) cardiovascular mortality (time-to-event)<br>c) days lost regarding 12month follow-up due to unplanned cardiovascular hospitalizations<br>d) days lost regarding 12month follow-up due to HF-hospitalization<br>e) number of unplanned cardiovascular hospitalizations (adjusted to death)<br>f) number of unplanned HF-hospitalizations (adjusted to death)<br>g) number of unplanned cardiovascular re-admissions within 30 days after discharge from unplanned cardiovascular hospitalization<br>h) quality of life, depression and self-care behaviour (Quality of life measured by Minnesota Living with Heart Failure Questionnaire; EQ-5D-3L, depression by PHQ-9 and self-care behaviour by EHFScBS-9)<br>i) cost-benefit analysis (QALYs = quality-adjusted life years from EQ-5D-3L)<br>