IN-TIME

IN-TIME

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

Hindricks et al., The Lancet 2014

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

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).

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Primary Endpoint of INTIME

Key Result 2

Significant reduction of all-cause mortality in heart failure patients of more than 60% and beneficial effect on the composite clinical score with implant-based (ICD or CRT-D) BIOTRONIK Home Monitoring® compared to standard care.

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Secondary Endpoint of INTIME

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%
  • A clinically relevant set of rhythmological and technical parameters
  • 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

Study Objective
  • Assessment of the impact of BIOTRONIK Home Monitoring® on the clinical status of heart failure patients
1° Endpoints
  • Modified Packer score: based on death, hospitalization, change in NYHA class, patient’s global self-assessment score
2° Endpoints
  • All–cause mortality
  • Number of HF hospitalizations and length(s) of stay
Clinical Sites
  • 36 centers (Australia, Austria, Czech Republic, Denmark, Germany, Israel and Latvia)
Sample Size
  • 664 patients
Inclusion Criteria
  • ICD indication (dual-chamber ICD, CRT-D)
  • Chronic heart failure
  • NYHA class II or III
  • LVEF ≤ 35%
Main Exclusion Criteria
  • Permanent atrial fibrillation
Devices
  • ICD and CRT-D
Flowchart Study Flowchart
Follow-Up
  • 12 months after randomization
Study Duration
  • July 2007 - December 2010
Reference no.
  • NCT00538356
Principal Investigators
  • Prof. Dr. Gerhard Hindricks, Herzzentrum Leipzig, Germany

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