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

NCT00538356 | Completed Phase 4

• 2 other identifiers: HS042There is no secondary ID
• Study Type: interventional
• Target: 720
• Locations: 6 countries
• Sites: 38

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.

Conditions

Ventricular Fibrillation; Ventricular Tachycardia; Congestive Heart Failure

Keywords

Heart failure; Rehospitalization:; Packer composite score; Home Monitoring; Cardiac resynchronization therapy; Implantable cardioverter-defibrillator

Outcome Measures

Primary Outcomes (1)

• Composite Score of death, hospitalization for heart failure, NYHA class and global assessment (Packer Score)

  12 months

Secondary Outcomes (1)

• 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

Study Arms (2)

Home Monitoring

EXPERIMENTAL

ICD or CRT-D with Home Monitoring feature activated Home Monitoring data will be analyzed regularly and patients will be contacted and scheduled for additional follow-up after predefined events

Device: ICD or CRT-D with Home Monitoring feature activated

Control

ACTIVE COMPARATOR

ICD or CRT-D with Home Monitoring feature deactivated Patients will be treated as per standard of care in each participating clinic

Device: ICD or CRT-D with Home Monitoring feature deactivated

Interventions

ICD or CRT-D with Home Monitoring feature deactivated DEVICE

Standard care

Control

ICD or CRT-D with Home Monitoring feature activated DEVICE

Standard care + patient management by Home Monitoring

Also known as: Biotronik Home Monitoring, Home Monitoring Service Center

Home Monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biotronik SE & Co. KG: lead

Study Sites (39)

Sydney Adventist Hospital

Wahroonga, 2076, Australia

Location

Universitätsklinik für Innere Medizin

Innsbruck, A-6020, Austria

Location

Institute of Clinical and Experimental Medicine

Prague, 14021, Czechia

Location

Hospital Na Homolce

Prague, 15030, Czechia

Location

Aalborg Hospital

Aalborg, 9100, Denmark

Location

Århus Universitetshospital, Skejby Sygehus

Århus N, 8200, Denmark

Location

Gentofte Hospital

Hellerup, 2900, Denmark

Location

Odense Universitets Hospital

Odense, 5000, Denmark

Location

Zentralklinik Bad Berka

Bad Berka, 99437, Germany

Location

Herz- und Gefäßklinikum Bad Neustadt GmbH

Bad Neustadt an der Saale, 97616, Germany

Location

Bad Segeberger Kliniken GmbH

Bad Segeberg, 23795, Germany

Location

Vivantes Klinikum Neukölln

Berlin, 04129, Germany

Location

Vivantes Klinikum am Urban

Berlin, 10967, Germany

Location

Universitätsklinikum Charité Campus Benjamin Franklin

Berlin, 12200, Germany

Location

Vivantes Humboldt Klinikum

Berlin, 13509, Germany

Location

Städtische Kliniken Bielefeld

Bielefeld, 22604, Germany

Location

Universitätsklinikum Bonn

Bonn, 53105, Germany

Location

Klinikum Coburg gGmbH

Coburg, 96450, Germany

Location

Klinikum Lippe-Detmold

Detmold, 32756, Germany

Location

Westdeutsches Herzzentrum des Universitätsklinikums Essen

Essen, 45122, Germany

Location

Universitätsklinikum Gießen und Marburg

Giessen, 35392, Germany

Location

Medizinische Hochschule

Hanover, 30625, Germany

Location

Universitätsklinikum des Saarlandes

Homburg/Saar, 66421, Germany

Location

Klinikum St. Georg gGmbH

Leipzig, 04129, Germany

Location

Herzzentrum der Universität Leipzig

Leipzig, 04289, Germany

Location

Universitätsklinik Schleswig-Holstein

Lübeck, 23538, Germany

Location

St. Marienhospital Lünen GmbH

Lünen, 44534, Germany

Location

Klinikum Schwabing, Kardiologie

Munich - Schwabing, Germany

Location

Kardiologische Gemeinschaftspraxis Dr. Mühling

München, 80379, Germany

Location

Stiftsklinik Augustinum, Innere Medizin / Kardiologie

München, 81375, Germany

Location

Klinikum der Universität München Großhadern

München, 81377, Germany

Location

Herzzentrum München-Bogenhausen

München, 81925, Germany

Location

Kardiologische Gemeinschaftspraxis Dr. Predel, Dr. Heinrich

Nordhausen, 99734, Germany

Location

St. Vincenz Krankenhaus GmbH

Paderborn, 33098, Germany

Location

Klinikum Pirna GmbH

Pirna, 01796, Germany

Location

Barzilai Medical Center

Ashkelon, 78306, Israel

Location

Rabin Medical Center

Petah Tikva, 49100, Israel

Location

Chaim Sheba Medical Center

Tel Litwinsky, 52621, Israel

Location

P. Stradins Clinical University Hospital, Latvian Centre of Cardiology

Riga, Latvia

Location

Related Publications (2)

• 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.

  PMID: 18805053 BACKGROUND

• 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.

  PMID: 25131977 DERIVED

MeSH Terms

Conditions

Ventricular Fibrillation; Tachycardia, Ventricular; Heart Failure

Interventions

Defibrillators, Implantable

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tachycardia; Cardiac Conduction System Disease

Intervention Hierarchy (Ancestors)

Defibrillators; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Electrodes, Implanted; Prostheses and Implants

Study Officials

• Gerhard Hindricks, Prof. Dr.

  Herzzentrum Leipzig, Germany

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2007
• First Posted: October 2, 2007
• Study Start: July 1, 2007
• Primary Completion: March 1, 2012
• Study Completion: August 1, 2013
• Last Updated: December 23, 2014

Record last verified: 2014-12

Locations

DK (4); AU (1); DE (27); IL (3); LA (1); CZ (2)