IN-TIME

IN-TIME

Influence of Home Monitoring on the Clinical Status of Heart Failure Patients

Hindricks et al., The Lancet 2014

Conclusion Home Monitoring reduces risk of worsened patients status and all-cause mortality for heart failure patients.

Inclusion Criteria
Indication for single chamber ICD, dual chamber ICD or CRT-D Chronic heart failure (≥ 3 months) NYHA Class II or III for 1 month prior to screening LVEF ≤ 35% within 3 months prior to screening Indication for therapy with diuretics Patient informed consent 18 years and older

Exclusion Criteria
Permanent atrial fibrillation Uncontrolled hypertension NYHA class I or IV Life expectancy < 1 year Restrictive, infiltrative or hypertrophic cardiomyopathy, constrictive pericarditis, acute myocarditis Etc.
 


Study Design

 

  • Randomized, controlled, international, multicenter study

  • Assesses the impact of BIOTRONIK Home Monitoring® on the clinical status of heart failure patients

  • 664 patients at 36 centers


 

Flowchart

Study duration: July 2007 – December 2010

Flowchart


 

Key Result 1

At 12 months follow-up, significantly fewer patients in the BIOTRONIK Home Monitoring® group worsened according to the modified Packer score compared to the control group (18.9% vs27.5%; p<0.05).

Primary Endpoint of INTIME

Modified Packer Score
Patients are classified as “worsened” in case of:

 

  • Death

  • Overnight hospitalization for worsening heart
  • failure

  • Worsening in NYHA Class

  • Deterioration in patient’s global self assessment

     

Key Result 2

Significant reduction of all-cause mortality in heart failure patients (> 50 %) and beneficial effect on the composite clinical score with implant-based (ICD or CRT-D) BIOTRONIK Home Monitoring® compared to standard care.

Secondary Endpoint of INTIME



>50% Reduction of Mortality

Clinical Relevance

  • The IN-TIME study demonstrated improved clinical status for heart failure patients by implementing a remote monitoring system based on:
  • A reliable transmission rate of 85%
  • Clinical workflow that enables fast patient contact and follow-up within one to two working days
  • The European Society of Cardiology added a clear recommendation for the use of implant-based remote follow-up to its guidelines1
  • A clinically relevant set of rhythmological and technical parameters

Reference no.
  • NCT00538356
Principal Investigators
  • Prof. Dr. Gerhard Hindricks, Herzzentrum Leipzig, Germany

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1Brignole M et al. 2013 ESC Guidelines on Cardiac Pacing and Cardiac Resynchronization Therapy. European Heart Journal. 2013, 34(29).