Monitoring of Hemodynamics in Heart Failure Patients by Intracardiac Impedance Measurement (BIODetectHFII)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Biotronik SE & Co. KG
Sponsor:
Information provided by (Responsible Party):
Biotronik SE & Co. KG
ClinicalTrials.gov Identifier:
NCT01711281
First received: October 16, 2012
Last updated: July 23, 2014
Last verified: July 2014
  Purpose

Heart Failure (HF) is one of the most frequent diagnoses upon hospitalization and is a major cause of death. Cardiac resynchronization therapy (CRT) using an implantable device for synchronous bi-ventricular stimulation leads to improvement of hemodynamic parameters, physical capacity and quality of life. A continuous measurement of the left-ventricular volume would provide information about heart performance and could be used for both heart failure monitoring and optimization of CRT-therapy.


Condition Intervention Phase
Heart Failure
Device: Intracardiac Impedance Measurement Algorithm (integrated in CRT-D device)
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Monitoring of Hemodynamics in Heart Failure Patients by Intracardiac Impedance Measurement

Resource links provided by NLM:


Further study details as provided by Biotronik SE & Co. KG:

Primary Outcome Measures:
  • Intra-indivudual correlation coefficient r between stroke volume (SV) and stroke impedance (SZ). [ Time Frame: Month 2 ] [ Designated as safety issue: No ]
    SV will be assessed using Echo Doppler Ao-VTI (Aortic velocity time integral). SZ will be measured in parallel using intracardiac impedance measurement. The parameters will be assessed during a sequential measurement being conducted in month 2 of the observational period. Hemodynamic changes will be actively provoked using the CRT-D system for overdrive-pacing.


Secondary Outcome Measures:
  • Intra-individual correlation coefficient r between left-ventricular end-systolic volume (LVESV) and left-ventricular end-systolic impedance (LVESZ). [ Time Frame: Month 2 ] [ Designated as safety issue: No ]
    LVESV will be assessed using echo Biplane Simpson's method. LVESZ will be measured using the intracardiac impedance measurement. The parameters will be assessed during a sequential measurement being conducted in month 2 of the observational period. Hemodynamic changes will be actively provoked using the CRT-D system for overdrive-pacing.


Other Outcome Measures:
  • Intra-individual correlation coefficient r between stroke volume (SV) and stroke impedance (SZ). [ Time Frame: Month 2 ] [ Designated as safety issue: No ]
    SV will be assessed using a non-invasive blood pressure measurement device. SZ will be measured using the intracardiac impedance measurement.The parameters will be assessed during a sequential measurement being conducted in month 2 of the observational period. Hemodynamic changes will be actively provoked using the CRT-D system for overdrive-pacing.


Estimated Enrollment: 60
Study Start Date: October 2012
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intracardiac Impedance Measurement Device: Intracardiac Impedance Measurement Algorithm (integrated in CRT-D device)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • De novo CRT-patients
  • Planned implantation with a Lumax 740 HF-T device, a bipolar LV-lead and a true bipolar RV-lead
  • NYHA class II or III
  • QRS ≥ 150 ms
  • LVEF between 15% and 35%
  • LVEDD ≥ 55 mm
  • Evaluable echo measurements

Exclusion Criteria:

  • Persistent or permanent atrial fibrillation
  • Heart surgery within the previous 3 months or planned for the time of study participation; post-heart transplantation or listed for heart transplantation
  • Non-ambulatory patients
  • Chronic renal dialysis
  • Life expectancy less than 1 year due to a non-cardiac disease
  • Age < 18 years and/or limited contractual capability
  • Addiction to alcohol, medical drugs or illegal drugs
  • Pregnant or breast-feeding women
  • Participation in another clinical trial
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01711281

Contacts
Contact: Helmuth Wagner, Dr. +49 30 68905 1302 helmuth.wagner@biotronik.com

Locations
Denmark
Aalborg Sygehus, Kardiologisk Afdeling Recruiting
Aalborg, Denmark, DK-9100
Contact: Ole Eschen, MD, PhD    +45 99324914    oe@rn.dk   
Principal Investigator: Ole Eschen, MD, PhD         
Aarhus Universitetshospital, Hjertemedicinsk Afdeling B Recruiting
Aarhus, Denmark, 8200
Contact: Jens C Nielsen, MD, PhD, Prof.    +45 78450999    jenniels@rm.dk   
Principal Investigator: Jens C Nielsen, MD, PhD, Prof.         
Gentofte Hospital, Department P Recruiting
Hellerup, Denmark, 2900
Contact: Niels E Bruun, MD, PhD, DMSc    +45 39777947    nibru@geh.regionh.dk   
Principal Investigator: Niels E Bruun, MD, PhD, DMSc         
Odense University Hospital, Hjertemedicinsk Afdeling B Recruiting
Odense, Denmark, 5000
Contact: Jens B Johansen, MD, PhD    +45 66113333    brock@dadlnet.dk   
Principal Investigator: Jens B Johansen, MD, PhD         
Germany
Herz- und Diabeteszentrum NRW Recruiting
Bad Oeynhausen, Germany, 32545
Contact: Klaus-Jürgen Gutleben, MD, PhD    +49 5731971327    kjgutleben@hdz-nrw.de   
Principal Investigator: Klaus-Jürgen Gutleben, MD, PhD         
Charité Campus Virchow-Klinik, Medizinische Klinik mit Schwerpunkt Kardiologie Not yet recruiting
Berlin, Germany, 13353
Contact: Mattias J Roser, MD, PhD    +49 30450553741    mattias.roser@charite.de   
Principal Investigator: Mattias J Roser, MD, PhD         
Herzzentrum Brandenburg, Immanuel Klinikum Recruiting
Bernau, Germany, 16321
Contact: Christian Butter, MD, PhD, PD    +49 3338694610    c.butter@immanuel.de   
Principal Investigator: Christian Butter, MD, PhD, PD         
Evangelisches Krankenhaus Not yet recruiting
Bielefeld, Germany, Bielefeld
Contact: Carsten W. Israel, PD Dr. med.    +49 521 - 77277525    carsten.israel@evkb.de   
Principal Investigator: Carsten W. Israel, PD. Dr. med.         
Klinikum Bielefeld Mitte Recruiting
Bielefeld, Germany, 33604
Contact: Christoph Stellbrink, MD, PhD, Prof.    +49 521 5813401    christoph.stellbrink@sk-bielefeld.de   
Principal Investigator: Christoph Stellbrink, MD, PhD, Prof.         
Universitätsklinikum Essen, Westdeutsches Herzzentrum Essen Recruiting
Essen, Germany, 45147
Contact: Nico Reinsch, Dr. med.    +49 201 723 84805    nico.reinsch@uk-essen.de   
Principal Investigator: Nico Reinsch, Dr. med.         
Medizinische Hochschule Hannover, Klinik für Kardiologie und Angiologie Recruiting
Hannover, Germany, 30625
Contact: Hanno HH Oswald, MD, PhD, PD    +49 5115326523    oswald.hanno@mh-hannover.de   
Principal Investigator: Hanno HH Oswald, MD, PhD, PD         
Kliniken Maria Hilf GmbH, Innere Medizin II, Klinik für Kardiologie Recruiting
Mönchengladbach, Germany, 41063
Contact: Istvan Szendey, MD, PhD,    +49 21618920    istvan.szendey@mariahilf.de   
Principal Investigator: Istvan Szendey, MD, PhD         
Klinikum der Universität München - Grosshadern Recruiting
München, Germany, 81377
Contact: Heidi L. Estner, PD Dr. med.    +49 89 70956036    heidi.estner@med.uni-muenchen.de   
Principal Investigator: Heidi L. Estner, PD Dr. med.         
Havellandklinik Nauen Not yet recruiting
Nauen, Germany, 16461
Contact: Martin Stickburger, PD Dr. med    +49 (0) 3321 42 1100    martin.stockburger@havelland-kliniken.de   
Principal Investigator: Martin Stockburger, PD Dr. med.         
Krankenhaus Reinbek St. Adolf-Stift, Innere Abt. Kardiologie Recruiting
Reinbek, Germany, 21465
Contact: Herbert Nägele, MD, PhD, Prof.    +49 4072805158    herbert-naegele@krankenhaus-reinbek.de   
Principal Investigator: Herbert Nägele, MD, PhD, Prof.         
Universitätsklinikum Würzburg, Medizinische Klinik und Poliklinik I, Medizinische Intensiv- und Notfallmedizin Recruiting
Würzburg, Germany, 97080
Contact: Oliver Ritter, MD, PhD, Prof.    +49 931 20139033    Ritter_O@klinik.uni-wuerzburg.de   
Principal Investigator: Oliver Ritter, MD, PhD, Prof.         
Italy
Azienda Ospedaliero Univesitaria, Ospedali Riuniti Umberto I- G.M. Lancisi- G. Salesi Not yet recruiting
Ancona, Italy, 60126
Contact: Alessandro Capucci, Prof. Dr.    +39 71 5965440    a.capucci@univpm.it   
Principal Investigator: Alessandro Capucci, Prof. Dr.         
Fondazione Toscana G. Monasterio Not yet recruiting
Pisa, Italy, 56124
Contact: Marcello Piacenti, Dr.         
Principal Investigator: Marcello Piacenti, Dr.         
Netherlands
Leiden University Medical Center Recruiting
Leiden, Netherlands, 2333 ZA
Contact: Lieselotte van Erven, MD, PhD    +31 715262020    l.van_erven@lumc.nl   
Principal Investigator: Lieselotte van Erven, MD, PhD         
Erasmus Medical Center Recruiting
Rotterdam, Netherlands, 3015CE
Contact: Tamás Szili-Török, Dr. med.    +31 (0) 6 33330605    t.szilitorok@erasmusmc.nl   
Principal Investigator: Tamás Szili-Török, Dr. med.         
Isala Klinieken, Hospital de Weezenlanden, Department of Cardiology Recruiting
Zwolle, Netherlands, 8011 JW
Contact: Peter-Paul HM Delnoy, MD, PhD    +31 384247025    p.p.h.m.delnoy@isala.nl   
Principal Investigator: Peter-Paul HM Delnoy, MD, PhD         
Switzerland
Universitätsspital Zürich Not yet recruiting
Zürich, Switzerland, 8091
Contact: Jan Steffel, PD Dr. med.    +41 43 343-1956    Jan.Steffel@usz.ch   
Principal Investigator: Jan Steffel, PD Dr. med.         
Sponsors and Collaborators
Biotronik SE & Co. KG
Investigators
Study Chair: Peter Sogaard, MD, PhD, Prof. Aalborg University, Aalborg University Hospital
Study Chair: Klaus-Jürgen Gutleben, MD, PhD Herz- und Diabeteszentrum NRW, Bad Oeynhausen
  More Information

No publications provided

Responsible Party: Biotronik SE & Co. KG
ClinicalTrials.gov Identifier: NCT01711281     History of Changes
Other Study ID Numbers: CR010
Study First Received: October 16, 2012
Last Updated: July 23, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Biotronik SE & Co. KG:
Heart Failure
Implantable Cardioverter-Defibrillator
Intracardiac Impedance Measurement
Cardiac Resynchronization Therapy
Home Monitoring
Reverse Remodeling

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014