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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
German Federal Ministry of Education and Research
University of Leipzig
Information provided by (Responsible Party):
Friedrich Koehler, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01878630
First received: June 12, 2013
Last updated: May 15, 2017
Last verified: May 2017
  Purpose

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

Condition Intervention Phase
Chronic Heart Failure Device: Remote Patient Management Other: Usual Care Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Remote patient management with telemedical devices (ECG, scale, blood-pressure device)
Masking: No masking
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Friedrich Koehler, Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Days lost due to unplanned cardiovascular hospitalization or death. [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • 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 Heart 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 ]

Enrollment: 1535
Study Start Date: August 2013
Estimated Study Completion Date: May 2018
Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Remote Patient Management
intervention group
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"
Active Comparator: Usual Care
control group
Other: Usual Care
Guideline-based care in heart failure including at least 5 scheduled doctor's visits within 12 months (GP and specialist)

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01878630

  Show 99 Study Locations
Sponsors and Collaborators
Charite University, Berlin, Germany
German Federal Ministry of Education and Research
University of Leipzig
Investigators
Principal Investigator: Friedrich Koehler, Prof. Dr. Charité - Universitaetsmedizin Berlin
  More Information

Additional Information:
Publications:
Responsible Party: Friedrich Koehler, Prof. Dr. Friedrich Koehler, MD, Senior Physician, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01878630     History of Changes
Other Study ID Numbers: 13KQ0904B
Study First Received: June 12, 2013
Last Updated: May 15, 2017

Keywords provided by Friedrich Koehler, Charite University, Berlin, Germany:
Chronic Heart Failure
CHF

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 28, 2017