Telemedical Interventional Monitoring in Heart Failure

NCT00543881 | Completed Phase 3 DMC

• 1 other identifier: 01MG531
• Study Type: interventional
• Target: 710
• Locations: 1 country
• Sites: 2

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

Conditions

Chronic Heart Failure

Keywords

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

Outcome Measures

Primary Outcomes (1)

• all cause mortality

Secondary Outcomes (1)

• 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

Study Arms (2)

1

EXPERIMENTAL

Interventional group

Device: Remote patient monitoring (Partnership for the Heart)

2

ACTIVE COMPARATOR

Usual care group

Device: Usual care group

Interventions

Remote patient monitoring (Partnership for the Heart) DEVICE

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

Also known as: brand name for remote patient monitoring system: Partnership for the Heart

1

Usual care group DEVICE

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

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• German Federal Ministry of Economics and Technology: collaborator

Study Sites (2)

Charité - Universitaetsmedizin Berlin

Berlin, 10117, Germany

Location

Robert-Bosch-Krankenhaus

Stuttgart, 70376, Germany

Location

Related Publications (13)

• 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.

  PMID: 16904569 BACKGROUND

• 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.

  PMID: 17315125 BACKGROUND

• 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.

  PMID: 20851481 BACKGROUND

• 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.

  PMID: 21856487 BACKGROUND

• 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.

  PMID: 21098580 BACKGROUND

• 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.

  PMID: 21444883 RESULT

• 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.

  PMID: 21982700 RESULT

• 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.

  PMID: 23702987 RESULT

• 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.

  PMID: 23962782 RESULT

• 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.

  PMID: 24722932 RESULT

• 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.

  PMID: 27892422 RESULT

• 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.

  PMID: 21429580 DERIVED

• 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.

  PMID: 19618202 DERIVED

Study Officials

• Friedrich Koehler, MD

  Charité - Universitaetsmedizin Berlin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Physician

Study Record Dates

• First Submitted: October 11, 2007
• First Posted: October 15, 2007
• Study Start: January 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: October 1, 2010
• Last Updated: December 21, 2016

Record last verified: 2016-12

Locations

DE (2)