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Telemedical Interventional Management in Heart Failure II (TIM-HF2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01878630
Recruitment Status : Completed
First Posted : June 17, 2013
Last Update Posted : August 3, 2018
Sponsor:
Collaborators:
German Federal Ministry of Education and Research
University of Leipzig
Information provided by (Responsible Party):
Friedrich Koehler, Charite University, Berlin, Germany

Tracking Information
First Submitted Date  ICMJE June 12, 2013
First Posted Date  ICMJE June 17, 2013
Last Update Posted Date August 3, 2018
Study Start Date  ICMJE August 8, 2013
Actual Primary Completion Date May 12, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 30, 2018)
Percentage of days lost due to unplanned cardiovascular (CV) hospitalisation or due to death for any reason during the individual patient follow-up time. [ Time Frame: 12 months/ individual-patient follow-up time. ]
The primary outcome analysis will be performed on the FAS using the adjudicated data and sensitivity analyses will be performed on a) the PP data set, and b) on the FAS censoring all data at day 365.
Original Primary Outcome Measures  ICMJE
 (submitted: June 14, 2013)
Days lost due to unplanned cardiovascular hospitalization or death. [ Time Frame: 12 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 2, 2018)
  • All-cause mortality during the individual patient follow-up time. [ Time Frame: individual patient follow-up time (+28 days of the final visit to a maximum 393 days) ]
    All-cause and cardiovascular mortality will be calculated as: The individual follow-up time as calculated for the primary outcome + 28 days for all patients to a maximum of 393 days.
  • Percentage of days lost due to unplanned cardiovascular hospitalisations during the individual patient follow-up time. [ Time Frame: 12 months/ individual follow-up time ]
  • Percentage of days lost due to unplanned HF-hospitalisations during the individual patient follow-up time [ Time Frame: 12 months/ individual follow-up time ]
  • Change in MLHFQ-questionnaire overall score between baseline and 365 days [ Time Frame: 12 months/ individual follow-up time ]
    The change in MLHFQ (Minnesota Living with Heart Failure Questionnaire) scores will be analysed using an analysis of covariance and the corresponding estimates with 95% confidence intervals and p-values will be provided.
  • Change in levels of NT-proBNP and of MR-proADM between baseline and 365 days. [ Time Frame: 12 months/ individual follow-up time ]
    The change in NT-proBNP and of MR-proADM levels will be analysed using an analysis of covariance and the corresponding estimates with 95% confidence intervals and p-values will be provided
Original Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2013)
  • all-cause mortality (time-to-event) [ Time Frame: 12 months ]
  • cardiovascular mortality (time-to-event) [ Time Frame: 12 months ]
  • days lost regarding 12month follow-up due to unplanned cardiovascular hospitalizations [ Time Frame: 12 months ]
  • days lost regarding 12month follow-up due to HF-hospitalization; number of unplanned cardiovascular hospitalizations (adjusted to death) [ Time Frame: 12 months ]
  • number of unplanned HF-hospitalizations (adjusted to death) [ Time Frame: 12 months ]
  • number of unplanned cardiovascular re-admissions within 30 days after discharge from unplanned cardiovascular hospitalization [ Time Frame: 12 months ]
  • quality of life, depression and self-care behaviour [ Time Frame: 12 months ]
    Quality of life measured by Minnesota Living with Hear Failure Questionnaire; EQ-5D-3L, depression by PHQ-9 and self-care behaviour by EHFScBS-9
  • cost-utility analysis (QALY-analysis) [ Time Frame: 12 months ]
Current Other Pre-specified Outcome Measures
 (submitted: August 2, 2018)
  • Change in Quality of life (QoL), depression and self-care behaviour between baseline and 365 days. [ Time Frame: 12 months (baseline and final visit) ]
    QoL measured by European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3L), depression by PHQ-9D and self-care behaviour by European Heart Failure Self-care Behaviour Scale (EHFScBS-9)
  • Change from baseline in biomarkers (MR-proADM, NT-proBNP, MR-proANP, PCT) stratified by LVEF (>45 vs ≤ 45) at 365 days. [ Time Frame: 12 months (baseline and final visit) ]
  • Unplanned cardiovascular hospitalisations and cardiovascular mortality. [ Time Frame: individual patient follow-up time (+28 days of the final visit to a maximum 393 days) ]
    Analysed as a recurrent event analysis
  • Unplanned cardiovascular hospitalisations and all-cause mortality. [ Time Frame: individual patient follow-up time (+28 days of the final visit to a maximum 393 days) ]
    Analysed as a recurrent event analysis
  • Unplanned heart failure hospitalisations and cardiovascular mortality. [ Time Frame: individual patient follow-up time (+28 days of the final visit to a maximum 393 days) ]
    Analysed as a recurrent event analysis
  • Unplanned heart failure hospitalisations and all-cause mortality. [ Time Frame: 12 month ]
    analysed as a recurrent event analysis
  • Cost-utility Analysis. [ Time Frame: 12 month/individual follow-up time ]
    QALY-analysis using EQ-5D-3L
  • Rate of unplanned cardiovascular hospitalisations after a first cardiovascular hospitalisation [ Time Frame: 12 months ]
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Telemedical Interventional Management in Heart Failure II
Official Title  ICMJE Telemedical Interventional Management in Heart Failure II
Brief Summary

Superiority 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
  • cardiovascular mortality
  • quality of life
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Remote patient management with telemedical devices (ECG, scale, blood-pressure device)
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Heart Failure
Intervention  ICMJE
  • Device: Remote Patient Management

    Guideline-based care in heart failure including at least 5 scheduled doctor's visits within 12 months (GP and specialist) plus devices for Remote Patient Management at patient site for daily monitoring of ECG, weight, blood pressure, self-report of health status:

    • weighing scale (Seca 861 with bluetooth, seca gmbh & co. kg.)
    • blood pressure device (UA767PBT with bluetooth, A&D Ltd.)
    • ECG-eventrecorder (PhysioMem® PM 1000, getemed Medizin- und Informationstechnik AG)
    • patient-communication platform (Physio-Gate® PG 1000, getemed Medizin- und Informationstechnik AG)
    • help call device (DORO Easy 510/ Doro HandlePlus 334gsm, doro AB)

    at center site:

    - electronic patient record (eHealth connect 2.0, T-Systems International)

    Other Name: R&D project "Fontane"
  • Other: Usual Care
    Guideline-based care in heart failure including at least 5 scheduled doctor's visits within 12 months (GP and specialist)
Study Arms  ICMJE
  • Experimental: Remote Patient Management
    intervention group
    Intervention: Device: Remote Patient Management
  • Active Comparator: Usual Care
    control group
    Intervention: Other: Usual Care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 24, 2018)
1571
Original Estimated Enrollment  ICMJE
 (submitted: June 14, 2013)
1500
Actual Study Completion Date  ICMJE May 17, 2018
Actual Primary Completion Date May 12, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • chronic heart failure New York Heart Association (NYHA) class II or III
  • echocardiographically determined left ventricular ejection fraction (LVEF) ≤45% or >45% + minimum 1 diuretic in permanent medicinal therapy
  • hospitalization due to decompensated HF within the last 12months before randomization
  • informed consent
  • 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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01878630
Other Study ID Numbers  ICMJE 13KQ0904B
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Friedrich Koehler, Charite University, Berlin, Germany
Study Sponsor  ICMJE Charite University, Berlin, Germany
Collaborators  ICMJE
  • German Federal Ministry of Education and Research
  • University of Leipzig
Investigators  ICMJE
Principal Investigator: Friedrich Koehler, Prof. Dr. Charité - Universitaetsmedizin Berlin
PRS Account Charite University, Berlin, Germany
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP