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).

Image

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.

Image

>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

Download Section


Related Products

CARDIAC RESYNCHRONIZATION THERAPY

BIOTRONIK offers an extensive product portfolio in the area of Cardiac Resynchronization.

Image
Tachycardia Therapy

CARDIAC REMOTE MONITORING

BIOTRONIK offers Home Monitoring for its complete product portfolio.

Image
Monitoring Teaser

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