Telemedical Interventional Management in Heart Failure II (TIM-HF2)
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| ClinicalTrials.gov Identifier: NCT01878630 |
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Recruitment Status :
Completed
First Posted : June 17, 2013
Last Update Posted : August 3, 2018
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Sponsor:
Charite University, Berlin, Germany
Collaborators:
German Federal Ministry of Education and Research
University of Leipzig
Information provided by (Responsible Party):
Friedrich Koehler, Charite University, Berlin, Germany
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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
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Heart Failure | Device: Remote Patient Management Other: Usual Care | Phase 3 |
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 : | Interventional (Clinical Trial) |
| Actual Enrollment : | 1571 participants |
| 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 |
| Official Title: | Telemedical Interventional Management in Heart Failure II |
| Study Start Date : | August 8, 2013 |
| Actual Primary Completion Date : | May 12, 2017 |
| Actual Study Completion Date : | May 17, 2018 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Heart Failure
| Arm | Intervention/treatment |
|---|---|
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Experimental: Remote Patient Management
intervention group
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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:
at center site: - electronic patient record (eHealth connect 2.0, T-Systems International) Other Name: R&D project "Fontane" |
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Active Comparator: Usual Care
control group
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Other: Usual Care
Guideline-based care in heart failure including at least 5 scheduled doctor's visits within 12 months (GP and specialist) |
Primary Outcome Measures :
- 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 Outcome Measures :
- 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
Other Outcome Measures:
- 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 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| 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
- 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)
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01878630
Locations
Show 109 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 |
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Friedrich Koehler, Prof. Dr. Friedrich Koehler, MD, Senior Physician, Charite University, Berlin, Germany |
| ClinicalTrials.gov Identifier: | NCT01878630 |
| Other Study ID Numbers: |
13KQ0904B |
| First Posted: | June 17, 2013 Key Record Dates |
| Last Update Posted: | August 3, 2018 |
| Last Verified: | August 2018 |
Keywords provided by Friedrich Koehler, Charite University, Berlin, Germany:
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Chronic Heart Failure CHF |
Additional relevant MeSH terms:
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Heart Failure Heart Diseases Cardiovascular Diseases |