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

This study is currently recruiting participants.
Verified August 2013 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: December 18, 2013
Last verified: August 2013
  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: Allocation: Non-Randomized
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: September 2014 (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
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         
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.         
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.         
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 Not yet 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 Not yet 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         
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: December 18, 2013
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 April 17, 2014