Heart FailurePhase 4BIODetectHFIINCT01711281
Monitoring of Hemodynamics in Heart Failure Patients by Intracardiac Impedance Measurement
A Phase 4 study testing Intracardiac Impedance Measurement Algorithm (integrated in CRT-D device) in people with Heart Failure, run by Biotronik SE & Co. KG at 22 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Intracardiac Impedance Measurement Algorithm (integrated in CRT-D device)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 22 sitesin 5 countries
- Study dates
- Oct 2012to Jun 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Addiction to alcohol, medical drugs or illegal drugs
- Pregnant or breast-feeding women
- Participation in another clinical trial
Trial locations and contacts
22 sites in 5 countries.
22 sites in 5 countries
Germany12 sites
Herz- und Diabeteszentrum NRW
Bad Oeynhausen, 32545
Charité Campus Virchow-Klinik, Medizinische Klinik mit Schwerpunkt Kardiologie
Berlin, 13353
Herzzentrum Brandenburg, Immanuel Klinikum
Bernau, 16321
Klinikum Bielefeld Mitte
Bielefeld, 33604
Evangelisches Krankenhaus
Bielefeld, Bielefeld
Universitätsklinikum Essen, Westdeutsches Herzzentrum Essen
Essen, 45147
Medizinische Hochschule Hannover, Klinik für Kardiologie und Angiologie
Hanover, 30625
Kliniken Maria Hilf GmbH, Innere Medizin II, Klinik für Kardiologie
Mönchengladbach, 41063
Klinikum der Universität München - Grosshadern
München, 81377
Havellandklinik Nauen
Nauen, 16461
Krankenhaus Reinbek St. Adolf-Stift, Innere Abt. Kardiologie
Reinbek, 21465
Universitätsklinikum Würzburg, Medizinische Klinik und Poliklinik I, Medizinische Intensiv- und Notfallmedizin
Würzburg, 97080
Denmark4 sites
Aalborg Sygehus, Kardiologisk Afdeling
Aalborg, DK-9100
Aarhus Universitetshospital, Hjertemedicinsk Afdeling B
Aarhus, 8200
Gentofte Hospital, Department P
Hellerup, 2900
Odense University Hospital, Hjertemedicinsk Afdeling B
Odense, 5000
Netherlands3 sites
Leiden University Medical Center
Leiden, 2333 ZA
Erasmus Medical Center
Rotterdam, 3015CE
Isala Klinieken, Hospital de Weezenlanden, Department of Cardiology
Zwolle, 8011 JW
Italy2 sites
Azienda Ospedaliero Univesitaria, Ospedali Riuniti Umberto I- G.M. Lancisi- G. Salesi
Ancona, 60126
Fondazione Toscana G. Monasterio
Pisa, 56124
About this study
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.
- Conditions
- Heart Failure
- Being tested
- Intracardiac Impedance Measurement Algorithm (integrated in CRT-D device)
- Keywords
- Heart Failure, Implantable Cardioverter-Defibrillator, Intracardiac Impedance Measurement, Cardiac Resynchronization Therapy, Home Monitoring, Reverse Remodeling
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracardiac Impedance Measurement Algorithm (integrated in CRT-D device)Device
| Study group | Role | What they receive |
|---|---|---|
| Intracardiac Impedance Measurement | Experimental | Not described Receives: Device: Intracardiac Impedance Measurement Algorithm (integrated in CRT-D device) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Month 2
Secondary outcomes (1)
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.
Measured: Month 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik SE & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Sogaard, MD, PhD, Prof., Study chair, Aalborg University, Aalborg University HospitalKlaus-Jürgen Gutleben, MD, PhD, Study chair, Herz- und Diabeteszentrum NRW, Bad Oeynhausen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01711281
- Sponsor's protocol ID
- CR010
- Acronym
- BIODetectHFII
- Status last verified
- Jul 2015
- First submitted
- 16 Oct 2012
- Last updated
- 15 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring of Hemodynamics in Heart Failure Patients by Intracardiac Impedance Measurement
- ClinicalTrials.gov ID
- NCT01711281
- Acronym / sponsor ID
- BIODetectHFII / CR010
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Implantable Cardioverter-Defibrillator, Intracardiac Impedance Measurement, Cardiac Resynchronization Therapy, Home Monitoring, Reverse Remodeling
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Biotronik SE & Co. KGIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Jun 2015 (actual)
- First posted
- 22 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intracardiac Impedance Measurement | Experimental | Device: Intracardiac Impedance Measurement Algorithm (integrated in CRT-D device) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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%
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intracardiac Impedance Measurement Algorithm (integrated in CRT-D device) | Device | Intracardiac Impedance Measurement |
Primary outcome
Intra-indivudual correlation coefficient r between stroke volume (SV) and stroke impedance (SZ).
Time frame: Month 2
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.
1 secondary outcome
Intra-individual correlation coefficient r between left-ventricular end-systolic volume (LVESV) and left-ventricular end-systolic impedance (LVESZ).
Time frame: Month 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Sogaard, MD, PhD, Prof. study chair
Aalborg University, Aalborg University Hospital
Klaus-Jürgen Gutleben, MD, PhD study chair
Herz- und Diabeteszentrum NRW, Bad Oeynhausen
22 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intracardiac Impedance Measurement Algorithm (integrated in CRT-D device) in people with Heart Failure, run by Biotronik SE & Co. KG at 22 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Germany, Denmark, Netherlands, Italy, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra-indivudual correlation coefficient r between stroke volume (SV) and stroke impedance (SZ). (time frame: Month 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2015.