Clinical trial NCT00538356: Influence of Home Monitoring on the Clinical Status of Heart Failure Patients With an Impaired Left Ventricular Function
Official title: IN-TIME: Influence of Home Monitoring on the Clinical Status of Heart Failure Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ventricular Fibrillation
Ventricular Tachycardia
Congestive Heart Failure
Keywords: Heart failure
Rehospitalization:
Packer composite score
Home Monitoring
Cardiac resynchronization therapy
Implantable cardioverter-defibrillator
Lead sponsor: Biotronik SE & Co. KG
Sponsor class: INDUSTRY
First posted: 2007-10-02
Enrollment: 720
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Composite Score of death, hospitalization for heart failure, NYHA class and global assessment (Packer Score)
timeFrame: 12 months
Secondary outcomes:
measure: 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
timeFrame: 12 months
Other outcomes:
Locations:
city: Wahroonga
country: Australia
facility: Sydney Adventist Hospital
city: Innsbruck
country: Austria
facility: Universitätsklinik für Innere Medizin
city: Praha
country: Czech Republic
facility: Institute of Clinical and Experimental Medicine
city: Praha
country: Czech Republic
facility: Hospital Na Homolce
city: Aalborg
country: Denmark
facility: Aalborg Hospital
city: Hellerup
country: Denmark
facility: Gentofte Hospital
city: Odense
country: Denmark
facility: Odense Universitets Hospital
city: Århus N
country: Denmark
facility: Århus Universitetshospital, Skejby Sygehus
city: Bad Berka
country: Germany
facility: Zentralklinik Bad Berka
city: Bad Neustadt
country: Germany
facility: Herz- und Gefäßklinikum Bad Neustadt GmbH
city: Bad Segeberg
country: Germany
facility: Bad Segeberger Kliniken GmbH
city: Berlin
country: Germany
facility: Vivantes Klinikum Neukölln
city: Berlin
country: Germany
facility: Vivantes Klinikum am Urban
city: Berlin
country: Germany
facility: Universitätsklinikum Charité Campus Benjamin Franklin
city: Berlin
country: Germany
facility: Vivantes Humboldt Klinikum
city: Bielefeld
country: Germany
facility: Städtische Kliniken Bielefeld
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
city: Coburg
country: Germany
facility: Klinikum Coburg gGmbH
city: Detmold
country: Germany
facility: Klinikum Lippe-Detmold
city: Essen
country: Germany
facility: Westdeutsches Herzzentrum des Universitätsklinikums Essen
city: Gießen
country: Germany
facility: Universitätsklinikum Gießen und Marburg
city: Hannover
country: Germany
facility: Medizinische Hochschule
city: Homburg/Saar
country: Germany
facility: Universitätsklinikum des Saarlandes
city: Leipzig
country: Germany
facility: Klinikum St. Georg gGmbH
city: Leipzig
country: Germany
facility: Herzzentrum der Universität Leipzig
city: Lübeck
country: Germany
facility: Universitätsklinik Schleswig-Holstein
city: Lünen
country: Germany
facility: St. Marienhospital Lünen GmbH
city: Munich - Schwabing
country: Germany
facility: Klinikum Schwabing, Kardiologie
city: München
country: Germany
facility: Kardiologische Gemeinschaftspraxis Dr. Mühling
city: München
country: Germany
facility: Stiftsklinik Augustinum, Innere Medizin / Kardiologie
city: München
country: Germany
facility: Klinikum der Universität München Großhadern
city: München
country: Germany
facility: Herzzentrum München-Bogenhausen
city: Nordhausen
country: Germany
facility: Kardiologische Gemeinschaftspraxis Dr. Predel, Dr. Heinrich
city: Paderborn
country: Germany
facility: St. Vincenz Krankenhaus GmbH
city: Pirna
country: Germany
facility: Klinikum Pirna GmbH
city: Ashkelon
country: Israel
facility: Barzilai Medical Center
city: Petach-Tikva
country: Israel
facility: Rabin Medical Center
city: Tel-Hashomer
country: Israel
facility: Chaim Sheba Medical Center
city: Riga
country: Latvia
facility: P. Stradins Clinical University Hospital, Latvian Centre of Cardiology
Study officials:
affiliation: Herzzentrum Leipzig, Germany
name: Gerhard Hindricks, Prof. Dr.
role: STUDY_CHAIR
References:
citation: Arya A, Block M, Kautzner J, Lewalter T, Mortel H, Sack S, Schumacher B, Sogaard 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.
citation: Hindricks G, Taborsky M, Glikson M, Heinrich U, Schumacher B, Katz A, Brachmann J, Lewalter T, Goette A, Block M, Kautzner J, Sack S, Husser D, Piorkowski C, Sogaard P; IN-TIME study group*. Implant-based multiparameter telemonitoring of patients with heart failure (IN-TIME): a randomised controlled trial. Lancet. 2014 Aug 16;384(9943):583-590. doi: 10.1016/S0140-6736(14)61176-4.