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

Primary Purpose

Heart Failure

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Intracardiac Impedance Measurement Algorithm (integrated in CRT-D device)
Sponsored by
Biotronik SE & Co. KG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Heart Failure focused on measuring Heart Failure, Implantable Cardioverter-Defibrillator, Intracardiac Impedance Measurement, Cardiac Resynchronization Therapy, Home Monitoring, Reverse Remodeling

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aalborg Sygehus, Kardiologisk Afdeling
  • Aarhus Universitetshospital, Hjertemedicinsk Afdeling B
  • Gentofte Hospital, Department P
  • Odense University Hospital, Hjertemedicinsk Afdeling B
  • Herz- und Diabeteszentrum NRW
  • Charité Campus Virchow-Klinik, Medizinische Klinik mit Schwerpunkt Kardiologie
  • Herzzentrum Brandenburg, Immanuel Klinikum
  • Klinikum Bielefeld Mitte
  • Evangelisches Krankenhaus
  • Universitätsklinikum Essen, Westdeutsches Herzzentrum Essen
  • Medizinische Hochschule Hannover, Klinik für Kardiologie und Angiologie
  • Kliniken Maria Hilf GmbH, Innere Medizin II, Klinik für Kardiologie
  • Klinikum der Universität München - Grosshadern
  • Havellandklinik Nauen
  • Krankenhaus Reinbek St. Adolf-Stift, Innere Abt. Kardiologie
  • Universitätsklinikum Würzburg, Medizinische Klinik und Poliklinik I, Medizinische Intensiv- und Notfallmedizin
  • Azienda Ospedaliero Univesitaria, Ospedali Riuniti Umberto I- G.M. Lancisi- G. Salesi
  • Fondazione Toscana G. Monasterio
  • Leiden University Medical Center
  • Erasmus Medical Center
  • Isala Klinieken, Hospital de Weezenlanden, Department of Cardiology
  • Universitätsspital Zürich

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intracardiac Impedance Measurement

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
October 16, 2012
Last Updated
July 14, 2015
Sponsor
Biotronik SE & Co. KG
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1. Study Identification

Unique Protocol Identification Number
NCT01711281
Brief Title
Monitoring of Hemodynamics in Heart Failure Patients by Intracardiac Impedance Measurement
Acronym
BIODetectHFII
Official Title
Monitoring of Hemodynamics in Heart Failure Patients by Intracardiac Impedance Measurement
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biotronik SE & Co. KG

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart Failure, Implantable Cardioverter-Defibrillator, Intracardiac Impedance Measurement, Cardiac Resynchronization Therapy, Home Monitoring, Reverse Remodeling

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intracardiac Impedance Measurement
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Intracardiac Impedance Measurement Algorithm (integrated in CRT-D device)
Primary Outcome Measure Information:
Title
Intra-indivudual correlation coefficient r between stroke volume (SV) and stroke impedance (SZ).
Description
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.
Time Frame
Month 2
Secondary Outcome Measure Information:
Title
Intra-individual correlation coefficient r between left-ventricular end-systolic volume (LVESV) and left-ventricular end-systolic impedance (LVESZ).
Description
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.
Time Frame
Month 2
Other Pre-specified Outcome Measures:
Title
Intra-individual correlation coefficient r between stroke volume (SV) and stroke impedance (SZ).
Description
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.
Time Frame
Month 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Sogaard, MD, PhD, Prof.
Organizational Affiliation
Aalborg University, Aalborg University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Klaus-Jürgen Gutleben, MD, PhD
Organizational Affiliation
Herz- und Diabeteszentrum NRW, Bad Oeynhausen
Official's Role
Study Chair
Facility Information:
Facility Name
Aalborg Sygehus, Kardiologisk Afdeling
City
Aalborg
ZIP/Postal Code
DK-9100
Country
Denmark
Facility Name
Aarhus Universitetshospital, Hjertemedicinsk Afdeling B
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Gentofte Hospital, Department P
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark
Facility Name
Odense University Hospital, Hjertemedicinsk Afdeling B
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Herz- und Diabeteszentrum NRW
City
Bad Oeynhausen
ZIP/Postal Code
32545
Country
Germany
Facility Name
Charité Campus Virchow-Klinik, Medizinische Klinik mit Schwerpunkt Kardiologie
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Herzzentrum Brandenburg, Immanuel Klinikum
City
Bernau
ZIP/Postal Code
16321
Country
Germany
Facility Name
Klinikum Bielefeld Mitte
City
Bielefeld
ZIP/Postal Code
33604
Country
Germany
Facility Name
Evangelisches Krankenhaus
City
Bielefeld
ZIP/Postal Code
Bielefeld
Country
Germany
Facility Name
Universitätsklinikum Essen, Westdeutsches Herzzentrum Essen
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Medizinische Hochschule Hannover, Klinik für Kardiologie und Angiologie
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Kliniken Maria Hilf GmbH, Innere Medizin II, Klinik für Kardiologie
City
Mönchengladbach
ZIP/Postal Code
41063
Country
Germany
Facility Name
Klinikum der Universität München - Grosshadern
City
München
ZIP/Postal Code
81377
Country
Germany
Facility Name
Havellandklinik Nauen
City
Nauen
ZIP/Postal Code
16461
Country
Germany
Facility Name
Krankenhaus Reinbek St. Adolf-Stift, Innere Abt. Kardiologie
City
Reinbek
ZIP/Postal Code
21465
Country
Germany
Facility Name
Universitätsklinikum Würzburg, Medizinische Klinik und Poliklinik I, Medizinische Intensiv- und Notfallmedizin
City
Würzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Azienda Ospedaliero Univesitaria, Ospedali Riuniti Umberto I- G.M. Lancisi- G. Salesi
City
Ancona
ZIP/Postal Code
60126
Country
Italy
Facility Name
Fondazione Toscana G. Monasterio
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Facility Name
Leiden University Medical Center
City
Leiden
ZIP/Postal Code
2333 ZA
Country
Netherlands
Facility Name
Erasmus Medical Center
City
Rotterdam
ZIP/Postal Code
3015CE
Country
Netherlands
Facility Name
Isala Klinieken, Hospital de Weezenlanden, Department of Cardiology
City
Zwolle
ZIP/Postal Code
8011 JW
Country
Netherlands
Facility Name
Universitätsspital Zürich
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland

12. IPD Sharing Statement

Learn more about this trial

Monitoring of Hemodynamics in Heart Failure Patients by Intracardiac Impedance Measurement

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