Telemedical Interventional Monitoring in Heart Failure

Chronic Heart Failure Clinical Trial

— TIM-HF  

Official title:

Telemedical Interventional Monitoring in Heart Failure (TIM-HF)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00543881
• Other study ID #: 01MG531
• Status: Completed
• Phase: Phase 3
• First received: October 11, 2007
• Last updated: December 20, 2016
• Start date: January 2008
• Est. completion date: October 2010

Study information

• Verified date: December 2016
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 710
• Est. completion date: October 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Ambulatory CHF NYHA II or III

2. 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

3. Optimal medical treatment for CHF (b-blocker, ACE-inhibitor/ ARB, diuretics) including ICD/CRT if indicated

4. Age = 18 years

5. Informed consent

Exclusion Criteria:

1. Existence of any disease (HF excluded) reducing life expectancy to less than 1 year

2. Insufficient compliance to telemonitoring or study visits

3. Impairment to use the telemonitoring equipment or appear to study visits (e.g. dementia, impaired self-determination, lacking ability to communicate)

4. Pregnancy

5. Concurrent participation in other therapy trials

6. Hospitalization for cardiac decompensation within 7 days before inclusion in trial

7. Implanted cardiac assist system

8. Unstable angina pectoris

9. Congenital heart defect

10. Primary heart valve disease

11. Hypertrophic or restrictive cardiomyopathy

12. Arrhythmogenic right ventricular cardiomyopathy

13. Acute myocarditis diagnosis ,1 year

14. Actively listed for heart transplantation

15. Planned revascularization or CRT implantation

16. Chronic renal insufficiency with creatinine .2.5 mg/dl

17. Liver cirrhosis

18. Known alcohol or drug abuse

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Intervention

Device:
• Remote patient monitoring (Partnership for the Heart)
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
• Usual care group
Guideline-based care in heart failure (NYHA II-III) including at least 5 scheduled doctor's visits

Locations

Country	Name	City	State
Germany	Charité - Universitaetsmedizin Berlin	Berlin
Germany	Robert-Bosch-Krankenhaus	Stuttgart

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	German Federal Ministry of Economics and Technology

Country where clinical trial is conducted

Germany, 

References & Publications (11)

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. Review. — View 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, reliab — View 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. — View Citation

Koehler F, Winkler S, Schieber M, Sechtem U, Stangl K, Böhm 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 morta — View Citation

Koehler F, Winkler S, Schieber M, Sechtem U, Stangl K, Böhm M, Boll H, Kim SS, Koehler K, Lücke 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. — View Citation

Koehler F, Winkler S, Schieber M, Sechtem U, Stangl K, Böhm 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 — View Citation

Köhler F, Schieber M, Lücke 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. German. — View Citation

Prescher S, Deckwart O, Koehler K, Lücke 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. German — View 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 — View 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- — View Citation

Winkler S, Schieber M, Lücke 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all cause mortality			Yes
Secondary	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

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