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IN-TIME Clinical Trial

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 Results

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).

IN-Time Key Result 1

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.

IN-Time Key Result 2

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

Study Details

Study Objective

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

Primary Endpoint

  • Modified Packer score: based on death, hospitalization, change in NYHA class, patient’s global self-assessment score

Major Secondary 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

Main 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

Study Flowchart

IN-Time 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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