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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biotronik SE & Co. KG
ClinicalTrials.gov Identifier:
NCT01711281
First received: October 16, 2012
Last updated: July 14, 2015
Last verified: July 2015
  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.


Enrollment: 68
Study Start Date: October 2012
Primary Completion Date: June 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

Locations
Denmark
Aalborg Sygehus, Kardiologisk Afdeling
Aalborg, Denmark, DK-9100
Aarhus Universitetshospital, Hjertemedicinsk Afdeling B
Aarhus, Denmark, 8200
Gentofte Hospital, Department P
Hellerup, Denmark, 2900
Odense University Hospital, Hjertemedicinsk Afdeling B
Odense, Denmark, 5000
Germany
Herz- und Diabeteszentrum NRW
Bad Oeynhausen, Germany, 32545
Charité Campus Virchow-Klinik, Medizinische Klinik mit Schwerpunkt Kardiologie
Berlin, Germany, 13353
Herzzentrum Brandenburg, Immanuel Klinikum
Bernau, Germany, 16321
Evangelisches Krankenhaus
Bielefeld, Germany, Bielefeld
Klinikum Bielefeld Mitte
Bielefeld, Germany, 33604
Universitätsklinikum Essen, Westdeutsches Herzzentrum Essen
Essen, Germany, 45147
Medizinische Hochschule Hannover, Klinik für Kardiologie und Angiologie
Hannover, Germany, 30625
Kliniken Maria Hilf GmbH, Innere Medizin II, Klinik für Kardiologie
Mönchengladbach, Germany, 41063
Klinikum der Universität München - Grosshadern
München, Germany, 81377
Havellandklinik Nauen
Nauen, Germany, 16461
Krankenhaus Reinbek St. Adolf-Stift, Innere Abt. Kardiologie
Reinbek, Germany, 21465
Universitätsklinikum Würzburg, Medizinische Klinik und Poliklinik I, Medizinische Intensiv- und Notfallmedizin
Würzburg, Germany, 97080
Italy
Azienda Ospedaliero Univesitaria, Ospedali Riuniti Umberto I- G.M. Lancisi- G. Salesi
Ancona, Italy, 60126
Fondazione Toscana G. Monasterio
Pisa, Italy, 56124
Netherlands
Leiden University Medical Center
Leiden, Netherlands, 2333 ZA
Erasmus Medical Center
Rotterdam, Netherlands, 3015CE
Isala Klinieken, Hospital de Weezenlanden, Department of Cardiology
Zwolle, Netherlands, 8011 JW
Switzerland
Universitätsspital Zürich
Zürich, Switzerland, 8091
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 14, 2015
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
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on September 03, 2015