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).

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.

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
Follow-Up	12 months after randomization
Study Duration	July 2007 - December 2010
Reference no.	NCT00538356
Principal Investigators	Prof. Dr. Gerhard Hindricks, Herzzentrum Leipzig, Germany