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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Device: Intracardiac Impedance Measurement Algorithm (integrated in CRT-D device)

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intracardiac Impedance Measurement	Device: Intracardiac Impedance Measurement Algorithm (integrated in CRT-D device)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intra-indivudual correlation coefficient r between stroke volume (SV) and stroke impedance (SZ).	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.	Month 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intra-individual correlation coefficient r between left-ventricular end-systolic volume (LVESV) and left-ventricular end-systolic impedance (LVESZ).	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.	Month 2

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intra-individual correlation coefficient r between stroke volume (SV) and stroke impedance (SZ).	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.	Month 2

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: October 16, 2012
• First Submitted That Met QC Criteria: October 18, 2012
• First Posted (Estimate): October 22, 2012

Study Record Updates

• Last Update Posted (Estimate): July 15, 2015
• Last Update Submitted That Met QC Criteria: July 14, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Heart Failure; Cardiac Resynchronization Therapy; Implantable Cardioverter-Defibrillator; Home Monitoring; Reverse Remodeling; Intracardiac Impedance Measurement
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: CR010