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Telemedical Interventional Monitoring in Heart Failure (TIM-HF)

Primary Purpose

Chronic Heart Failure

Status

Completed

Phase

Phase 3

Locations

Germany

Study Type

Interventional

Intervention

Remote patient monitoring (Partnership for the Heart)

Usual care group

About this trial

This is an interventional treatment trial for Chronic Heart Failure focused on measuring telemedicine, remote patient monitoring, chronic heart failure, mortality, health economics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Ambulatory CHF NYHA II or III
LVEF ≤ 35% and cardiac decompensation with hospitalization for heart failure or therapy with intravenous diuretics (.40 mg furosemide/day) within 24 months prior to enrolment or LVEF ≤ 25%, measured twice within past 6 months
Optimal medical treatment for CHF (b-blocker, ACE-inhibitor/ ARB, diuretics) including ICD/CRT if indicated
Age ≥ 18 years
Informed consent

Exclusion Criteria:

Existence of any disease (HF excluded) reducing life expectancy to less than 1 year
Insufficient compliance to telemonitoring or study visits
Impairment to use the telemonitoring equipment or appear to study visits (e.g. dementia, impaired self-determination, lacking ability to communicate)
Pregnancy
Concurrent participation in other therapy trials
Hospitalization for cardiac decompensation within 7 days before inclusion in trial
Implanted cardiac assist system
Unstable angina pectoris
Congenital heart defect
Primary heart valve disease
Hypertrophic or restrictive cardiomyopathy
Arrhythmogenic right ventricular cardiomyopathy
Acute myocarditis diagnosis ,1 year
Actively listed for heart transplantation
Planned revascularization or CRT implantation
Chronic renal insufficiency with creatinine .2.5 mg/dl
Liver cirrhosis
Known alcohol or drug abuse

Sites / Locations

Charité - Universitaetsmedizin Berlin
Robert-Bosch-Krankenhaus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Interventional group

Usual care group

Outcomes

Primary Outcome Measures

all cause mortality

Secondary Outcome Measures

comp of the combined rate of cv death and hosp. for worsening HF;days lost due to cv death or HF hosp;cv mortality;Rate of cv hosp;Rate of hosp for HF;hosp for any reason;cv hosp;hosp for HF;duration of all hosp for HF;NYHA class; SF-36; PHQ-9 score

Full Information

NCT ID

NCT00543881

First Posted

October 11, 2007

Last Updated

December 20, 2016

Sponsor

Charite University, Berlin, Germany

Collaborators

German Federal Ministry of Economics and Technology

1. Study Identification

Unique Protocol Identification Number

NCT00543881

Brief Title

Telemedical Interventional Monitoring in Heart Failure

Acronym

TIM-HF

Official Title

Telemedical Interventional Monitoring in Heart Failure (TIM-HF)

Study Type

Interventional

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Completed

Study Start Date

January 2008 (undefined)

Primary Completion Date

July 2010 (Actual)

Study Completion Date

October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Charite University, Berlin, Germany

Collaborators

German Federal Ministry of Economics and Technology

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Superiority of additional Remote Patient Monitoring in patients with CHF In comparison to usual care in terms of: reduction of mortality rate reduction of hospitalizations increasement of patients' quality of life

Detailed Description

The clinical trial assesses 710 patients over a period of at least 15 months each (2008 until 2010); all participants will continue to receive usual care from their GP. All patients will be examined at the beginning of the study and will undergo a check-up every 3 months. 355 of the patients will be randomly allocated to receive devices for Remote Patient Monitoring 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Heart Failure

Keywords

telemedicine, remote patient monitoring, chronic heart failure, mortality, health economics

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

710 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Interventional group

Arm Title

Arm Type

Active Comparator

Arm Description

Usual care group

Intervention Type

Device

Intervention Name(s)

Remote patient monitoring (Partnership for the Heart)

Other Intervention Name(s)

brand name for remote patient monitoring system: Partnership for the Heart

Intervention Description

Guideline-based care in heart failure (NYHA II-III) including at least 5 scheduled doctor's visits plus daily monitoring of ECG, weight, blood pressure, self-report of health status, weekly monitoring of physical fitness

Intervention Type

Device

Intervention Name(s)

Usual care group

Intervention Description

Guideline-based care in heart failure (NYHA II-III) including at least 5 scheduled doctor's visits

Primary Outcome Measure Information:

Title

all cause mortality

Secondary Outcome Measure Information:

Title

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Ambulatory CHF NYHA II or III LVEF ≤ 35% and cardiac decompensation with hospitalization for heart failure or therapy with intravenous diuretics (.40 mg furosemide/day) within 24 months prior to enrolment or LVEF ≤ 25%, measured twice within past 6 months Optimal medical treatment for CHF (b-blocker, ACE-inhibitor/ ARB, diuretics) including ICD/CRT if indicated Age ≥ 18 years Informed consent Exclusion Criteria: Existence of any disease (HF excluded) reducing life expectancy to less than 1 year Insufficient compliance to telemonitoring or study visits Impairment to use the telemonitoring equipment or appear to study visits (e.g. dementia, impaired self-determination, lacking ability to communicate) Pregnancy Concurrent participation in other therapy trials Hospitalization for cardiac decompensation within 7 days before inclusion in trial Implanted cardiac assist system Unstable angina pectoris Congenital heart defect Primary heart valve disease Hypertrophic or restrictive cardiomyopathy Arrhythmogenic right ventricular cardiomyopathy Acute myocarditis diagnosis ,1 year Actively listed for heart transplantation Planned revascularization or CRT implantation Chronic renal insufficiency with creatinine .2.5 mg/dl Liver cirrhosis Known alcohol or drug abuse

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Friedrich Koehler, MD

Organizational Affiliation

Charité - Universitaetsmedizin Berlin

Official's Role

Principal Investigator

Facility Information:

Facility Name

Charité - Universitaetsmedizin Berlin

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

Robert-Bosch-Krankenhaus

City

Stuttgart

ZIP/Postal Code

70376

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

16904569

Citation

Koehler F, Anker SD. Noninvasive home telemonitoring: the Trans-European Network-Home-Care Management System. J Am Coll Cardiol. 2006 Aug 15;48(4):850-1; author reply 851-2. doi: 10.1016/j.jacc.2006.05.033. Epub 2006 Jul 24. No abstract available.

Results Reference

background

PubMed Identifier

17315125

Citation

Kohler F, Schieber M, Lucke S, Heinze P, Henke S, Matthesius G, Pferdt T, Wegertseder D, Stoll M, Anker SD. ["Partnership for the Heart"--development and testing of a new remote patient monitoring system]. Dtsch Med Wochenschr. 2007 Mar 2;132(9):458-60. doi: 10.1055/s-2007-970358. No abstract available. German.

Results Reference

background

PubMed Identifier

20851481

Citation

Winkler S, Schieber M, Lucke S, Heinze P, Schweizer T, Wegertseder D, Scherf M, Nettlau H, Henke S, Braecklein M, Anker SD, Koehler F. A new telemonitoring system intended for chronic heart failure patients using mobile telephone technology--feasibility study. Int J Cardiol. 2011 Nov 17;153(1):55-8. doi: 10.1016/j.ijcard.2010.08.038. Epub 2010 Sep 18.

Results Reference

background

PubMed Identifier

21856487

Citation

Anker SD, Koehler F, Abraham WT. Telemedicine and remote management of patients with heart failure. Lancet. 2011 Aug 20;378(9792):731-9. doi: 10.1016/S0140-6736(11)61229-4.

Results Reference

background

PubMed Identifier

21098580

Citation

Koehler F, Winkler S, Schieber M, Sechtem U, Stangl K, Bohm M, Boll H, Kim SS, Koehler K, Lucke S, Honold M, Heinze P, Schweizer T, Braecklein M, Kirwan BA, Gelbrich G, Anker SD; TIM-HF Investigators. Telemedical Interventional Monitoring in Heart Failure (TIM-HF), a randomized, controlled intervention trial investigating the impact of telemedicine on mortality in ambulatory patients with heart failure: study design. Eur J Heart Fail. 2010 Dec;12(12):1354-62. doi: 10.1093/eurjhf/hfq199.

Results Reference

background

PubMed Identifier

21444883

Citation

Koehler F, Winkler S, Schieber M, Sechtem U, Stangl K, Bohm M, Boll H, Baumann G, Honold M, Koehler K, Gelbrich G, Kirwan BA, Anker SD; Telemedical Interventional Monitoring in Heart Failure Investigators. Impact of remote telemedical management on mortality and hospitalizations in ambulatory patients with chronic heart failure: the telemedical interventional monitoring in heart failure study. Circulation. 2011 May 3;123(17):1873-80. doi: 10.1161/CIRCULATIONAHA.111.018473. Epub 2011 Mar 28.

Results Reference

result

PubMed Identifier

21982700

Citation

Koehler F, Winkler S, Schieber M, Sechtem U, Stangl K, Bohm M, de Brouwer S, Perrin E, Baumann G, Gelbrich G, Boll H, Honold M, Koehler K, Kirwan BA, Anker SD. Telemedicine in heart failure: pre-specified and exploratory subgroup analyses from the TIM-HF trial. Int J Cardiol. 2012 Nov 29;161(3):143-50. doi: 10.1016/j.ijcard.2011.09.007. Epub 2011 Oct 8.

Results Reference

result

PubMed Identifier

23702987

Citation

Prescher S, Deckwart O, Winkler S, Koehler K, Honold M, Koehler F. Telemedical care: feasibility and perception of the patients and physicians: a survey-based acceptance analysis of the Telemedical Interventional Monitoring in Heart Failure (TIM-HF) trial. Eur J Prev Cardiol. 2013 Jun;20(2 Suppl):18-24. doi: 10.1177/2047487313487483e.

Results Reference

result

PubMed Identifier

23962782

Citation

Jehn M, Prescher S, Koehler K, von Haehling S, Winkler S, Deckwart O, Honold M, Sechtem U, Baumann G, Halle M, Anker SD, Koehler F. Tele-accelerometry as a novel technique for assessing functional status in patients with heart failure: feasibility, reliability and patient safety. Int J Cardiol. 2013 Oct 12;168(5):4723-8. doi: 10.1016/j.ijcard.2013.07.171. Epub 2013 Jul 25.

Results Reference

result

PubMed Identifier

24722932

Citation

Prescher S, Deckwart O, Koehler K, Lucke S, Schieber M, Wellge B, Winkler S, Baumann G, Koehler F. [Will telemonitoring be adopted by patients with chronic heart failure?]. Dtsch Med Wochenschr. 2014 Apr;139(16):829-34. doi: 10.1055/s-0034-1369849. Epub 2014 Apr 10. German.

Results Reference

result

PubMed Identifier

27892422

Citation

Prescher S, Schoebel C, Koehler K, Deckwart O, Wellge B, Honold M, Hartmann O, Winkler S, Koehler F. Prognostic value of serial six-minute walk tests using tele-accelerometry in patients with chronic heart failure: A pre-specified sub-study of the TIM-HF-Trial. Eur J Prev Cardiol. 2016 Oct;23(2 suppl):21-26. doi: 10.1177/2047487316671438.

Results Reference

result

PubMed Identifier

21429580

Citation

Jehn M, Halle M, Schuster T, Hanssen H, Koehler F, Schmidt-Trucksass A. Multivariable analysis of heart rate recovery after cycle ergometry in heart failure: exercise in heart failure. Heart Lung. 2011 Nov-Dec;40(6):e129-37. doi: 10.1016/j.hrtlng.2011.01.005. Epub 2011 Mar 23.

Results Reference

derived

PubMed Identifier

19618202

Citation

Jehn M, Halle M, Schuster T, Hanssen H, Weis M, Koehler F, Schmidt-Trucksass A. The 6-min walk test in heart failure: is it a max or sub-maximum exercise test? Eur J Appl Physiol. 2009 Oct;107(3):317-23. doi: 10.1007/s00421-009-1128-0. Epub 2009 Jul 18.

Results Reference

derived

Links:

URL

http://telemedizin.charite.de/en

Description

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