Influence of Home Monitoring on the Clinical Status of Heart Failure Patients With an Impaired Left Ventricular Function

Congestive Heart Failure Clinical Trial

— IN-TIME  

Official title:

IN-TIME: Influence of Home Monitoring on the Clinical Status of Heart Failure Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00538356
• Other study ID #: HS042
• Secondary ID: There is no seco
• Status: Completed
• Phase: Phase 4
• First received: October 1, 2007
• Last updated: December 19, 2014
• Start date: July 2007
• Est. completion date: August 2013

Study information

• Verified date: December 2014
• Source: Biotronik SE & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

Re-hospitalizations or deaths by worsening heart failure are often preceded by distinct trends of clinical parameters such as atrial or ventricular arrhythmia, activity, heart rate variability, or ventricular ectopy. The Home Monitoring™ capability offered by BIOTRONIK active implants has the potential to detect some of these trends early and thus to offer the possibility to intervene in time for prevention of fatal worsening of heart failure.

To investigate the predictive value of Home Monitoring parameters, patients with symptomatic heart failure and reduced ejection fraction receiving an implantable cardioverter-defibrillator (ICD) or an ICD in combination with cardiac resynchronization therapy (CRT-D) will be randomized between prospective patient management by Home Monitoring analysis or standard care. The influence of Home Monitoring on the clinical status of heart failure patients will be assessed.

Description:

Hospital admissions or deaths by worsening heart failure are often preceded by distinct trends of clinical parameters such as heart rhythm disturbances, daily physical activity of a patient, or mean heart rates.

The Home Monitoring™ capability offered by many BIOTRONIK implants has the potential to detect some of these trends early. During Home Monitoring surveillance, medical and technical data from an ICD or CRT device are sent to a modified mobile phone, the so-called Cardio Messenger. This device transmits the data via a mobile phone network to the BIOTRONIK service center. There, the data are put into an easily accessible form and can then be viewed by the physician online via the internet on a secure website. Additionally, the occurrence of heart rhythm disturbances or device problems will be transmitted by fax, SMS or email.

This unique system allows the attending physician to monitor each patient very closely and to react early enough to prevent worsening of heart failure at an early stage, to optimize therapy, and to secure the correct functioning of the implant.

The goal of IN-TIME is thus to analyze the impact of a regular Home Monitoring evaluation on the health status of heart failure patients receiving such an implant as part of their therapy.

A total of 720 patients with heart failure symptoms and a severely reduced pumping function receiving an ICD or a CRT-D device from up to 50 European clinical centers will be enrolled into the study. About 4 weeks after discharge from the implanting hospital, patients will be randomly assigned to prospective patient management by Home Monitoring or standard care groups. Patients in the Home Monitoring group will be monitored at least once per week, patients in the control group will not be monitored during the study, but their transmitted Home Monitoring data will be analyzed after their ending of participation in the study.

The health status of patients will be measured using the well established "Packer Score". This score is a combined measurement of death rates, hospital admission rates, heart failure symptom classification and quality of life. Patients will be classified at their end of study participation as worsened, unchanged, or improved based on these parameters. To this end, the health status of participating patients will be determined regularly during further outpatient follow ups. These will take place at regular intervals due to the standard care.

Additionally, some special parameters sent to the physician via Home Monitoring will be analyzed whether they could possibly predict an imminent worsening of a patient's health - leading to an unplanned hospital visit - so that it could perhaps be prevented in the future.

Patients remain within the study for 12 months after randomization or until their participation is ended prematurely, e.g. by withdrawal of their consent, a low data transmission rate, or death.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 720
• Est. completion date: August 2013
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Exclusion Criteria:

• Uncontrolled hypertension

• NYHA class I or IV

• Permanent atrial fibrillation

• Life expectancy < 1 year

• Restrictive, infiltrative or hypertrophic cardiomyopathy, constrictive pericarditis, acute myocarditis

• Severe mitral regurgitation

• Symptomatic aortic stenosis

• Tricuspid valve replacement

• Known drug or alcohol abuse

• Expected non-compliance

• Pregnancy

• Participation in another telemonitoring concept

• Participation in another study

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Fibrillation
• Ventricular Tachycardia

Intervention

Device:
• ICD or CRT-D with Home Monitoring feature deactivated
Standard care
• ICD or CRT-D with Home Monitoring feature activated
Standard care + patient management by Home Monitoring

Locations

Country	Name	City	State
Australia	Sydney Adventist Hospital	Wahroonga
Austria	Universitätsklinik für Innere Medizin	Innsbruck
Czech Republic	Hospital Na Homolce	Praha
Czech Republic	Institute of Clinical and Experimental Medicine	Praha
Denmark	Aalborg Hospital	Aalborg
Denmark	Århus Universitetshospital, Skejby Sygehus	Århus N
Denmark	Gentofte Hospital	Hellerup
Denmark	Odense Universitets Hospital	Odense
Germany	Zentralklinik Bad Berka	Bad Berka
Germany	Herz- und Gefäßklinikum Bad Neustadt GmbH	Bad Neustadt
Germany	Bad Segeberger Kliniken GmbH	Bad Segeberg
Germany	Universitätsklinikum Charité Campus Benjamin Franklin	Berlin
Germany	Vivantes Humboldt Klinikum	Berlin
Germany	Vivantes Klinikum am Urban	Berlin
Germany	Vivantes Klinikum Neukölln	Berlin
Germany	Städtische Kliniken Bielefeld	Bielefeld
Germany	Universitätsklinikum Bonn	Bonn
Germany	Klinikum Coburg gGmbH	Coburg
Germany	Klinikum Lippe-Detmold	Detmold
Germany	Westdeutsches Herzzentrum des Universitätsklinikums Essen	Essen
Germany	Universitätsklinikum Gießen und Marburg	Gießen
Germany	Medizinische Hochschule	Hannover
Germany	Universitätsklinikum des Saarlandes	Homburg/Saar
Germany	Herzzentrum der Universität Leipzig	Leipzig
Germany	Klinikum St. Georg gGmbH	Leipzig
Germany	Universitätsklinik Schleswig-Holstein	Lübeck
Germany	St. Marienhospital Lünen GmbH	Lünen
Germany	Herzzentrum München-Bogenhausen	München
Germany	Kardiologische Gemeinschaftspraxis Dr. Mühling	München
Germany	Klinikum der Universität München Großhadern	München
Germany	Stiftsklinik Augustinum, Innere Medizin / Kardiologie	München
Germany	Klinikum Schwabing, Kardiologie	Munich - Schwabing
Germany	Kardiologische Gemeinschaftspraxis Dr. Predel, Dr. Heinrich	Nordhausen
Germany	St. Vincenz Krankenhaus GmbH	Paderborn
Germany	Klinikum Pirna GmbH	Pirna
Israel	Barzilai Medical Center	Ashkelon
Israel	Rabin Medical Center	Petach-Tikva
Israel	Chaim Sheba Medical Center	Tel-Hashomer
Latvia	P. Stradins Clinical University Hospital, Latvian Centre of Cardiology	Riga

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik SE & Co. KG

Countries where clinical trial is conducted

Australia,  Austria,  Czech Republic,  Denmark,  Germany,  Israel,  Latvia, 

References & Publications (1)

Arya A, Block M, Kautzner J, Lewalter T, Mörtel H, Sack S, Schumacher B, Søgaard P, Taborsky M, Husser D, Hindricks G; IN-TIME investigators. Influence of Home Monitoring on the clinical status of heart failure patients: Design and rationale of the IN-TIME study. Eur J Heart Fail. 2008 Nov;10(11):1143-8. doi: 10.1016/j.ejheart.2008.08.004. Epub 2008 Sep 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite Score of death, hospitalization for heart failure, NYHA class and global assessment (Packer Score)		12 months	No
Secondary	Rehospitalizations due to worsening heart failure; Correlation of Home Monitoring values with the clinical status; Incidence and reasons for Home Monitoring based interventions; Home Monitoring workflow analysis		12 months	No