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Completed

NCT Number: NCT01878630

Telemedical Interventional Management in Heart Failure II

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

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Key information

Conditions

Chronic Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Klinikum St. Marien Amberg - Medizinische Klinik I, Amberg, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Remote Patient Management

Device

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 names: R&D project "Fontane"

Usual Care

Other

Guideline-based care in heart failure including at least 5 scheduled doctor's visits within 12 months (GP and specialist)

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Percentage of days lost due to unplanned cardiovascular hospitalisations during the individual patient follow-up time.

    Time frame: 12 months/ individual follow-up time

  3. Percentage of days lost due to unplanned HF-hospitalisations during the individual patient follow-up time

    Time frame: 12 months/ individual follow-up time

  4. 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.

  5. 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

Other outcomes

  1. 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)

  2. 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)

  3. 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

  4. 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

  5. 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

  6. Unplanned heart failure hospitalisations and all-cause mortality.

    Time frame: 12 month

    analysed as a recurrent event analysis

  7. Cost-utility Analysis.

    Time frame: 12 month/individual follow-up time

    QALY-analysis using EQ-5D-3L

  8. Rate of unplanned cardiovascular hospitalisations after a first cardiovascular hospitalisation

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • German Federal Ministry of Education and Research
  • University of Leipzig

Registry information

Acronym: TIM-HF2

Important dates

Study start
2013
Primary completion
2017
Study completion
2018
First posted
Jun 17, 2013
Registry last updated
Aug 3, 2018

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.

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