Trial document




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  DRKS00010239

Trial Description

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Title

Telemedical Interventional Management in Heart Failure II

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Trial Acronym

TIM-HF2

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The clinical trial assesses 1,500 patients over a period of 12 months each (2013 until 2015). All participants will continue to receive usual care from their general practitioner and specialist. All patients will be examined at the beginning of the study and will undergo a check-up every 3 months. 750 of the patients will be randomly allocated to receive devices for Remote Patient Management (RPM) which will measure various parameters on a daily basis (e.g. weight, blood pressure, heart rate). The devices are mobile and can be used at home or elsewhere.

The TIM-HF2 protocol planned that upon completion of the trial, patients should be followed for additional 12 months. The aim was to evaluate, if the benefit seen in the RPM group, compared to the UC was sustained after stopping the RPM intervention.

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Brief Summary in Scientific Language

The purpose of the study is to proof the ouperiority of additional Remote Patient Management (RPM) in patients with chronic heart failure (CHF) in comparison to usual care in terms of, e.g.:days lost due to unplanned cardiovascular hospitalization or death; all-cause mortality and quality of life.

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Organizational Data

  •   DRKS00010239
  •   2016/04/01
  •   2013/06/12
  •   yes
  •   Approved
  •   EA2/065/13, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

  •   NCT01878630  (Clinicaltrials.gov)
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Health Condition or Problem studied

  •   I50 -  Heart failure
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Interventions/Observational Groups

  •   Usual Care according Guidelines for Chronic Heart Failure and daily measurement of ECG, blood pressure, weight, Spo2 and daily treatment by physicians of the telemedical Center for 12 months
  •   Usual Care according Guidelines for Chronic Heart Failure for 12 months
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Control group receives no treatment
  •   Treatment
  •   Parallel
  •   III
  •   N/A
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Primary Outcome

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

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Secondary Outcome

Time Frame: 12 Months
a) all-cause mortality (time-to-event)
b) cardiovascular mortality (time-to-event)
c) days lost regarding 12month follow-up due to unplanned cardiovascular hospitalizations
d) days lost regarding 12month follow-up due to HF-hospitalization
e) number of unplanned cardiovascular hospitalizations (adjusted to death)
f) number of unplanned HF-hospitalizations (adjusted to death)
g) number of unplanned cardiovascular re-admissions within 30 days after discharge from unplanned cardiovascular hospitalization
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)
i) cost-benefit analysis (QALYs = quality-adjusted life years from EQ-5D-3L)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
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  • Doctor's Practice 
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  • Doctor's Practice 
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  • Medical Center 
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Recruitment

  •   Actual
  •   2013/08/06
  •   1500
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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)

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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)

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Addresses

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    • Charité Campus Charité Mitte
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Universitätsklinikum Hamburg-EppendorfZentrum für Experimentelle Medizin Institut für Medizinische Biometrie und Epidemiologie
    • Mr.  Prof. Dr.   Karl   Wegscheider 
    • Martinistr. 52
    • 20246  Hamburg
    • Germany
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    • Zentrum für Klinische Studien (ZKS) LeipzigMedizinische Fakultät, Universität Leipzig
    • Härtelstraße 16-18
    • 04107  Leipzig
    • Germany
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    • Charité Campus Mitte; Med. Klinik m.S. Kardiologie und Angiologie; Zentrum für kardiovaskuläre Telemedizin
    • Mr.  Prof. Dr.   Friedrich  Köhler 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Charité Campus Mitte; Med. Klinik m.S. Kardiologie und Angiologie; Zentrum für kardiovaskuläre Telemedizin
    • Mr.  Prof. Dr.   Friedrich  Köhler 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Kapelle-Ufer 1
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2018/05/17
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Trial Publications, Results and other Documents

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