Clinical trial NCT01711281: Monitoring of Hemodynamics in Heart Failure Patients by Intracardiac Impedance Measurement
Official title: Monitoring of Hemodynamics in Heart Failure Patients by Intracardiac Impedance Measurement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heart Failure
Keywords: Heart Failure
Implantable Cardioverter-Defibrillator
Intracardiac Impedance Measurement
Cardiac Resynchronization Therapy
Home Monitoring
Reverse Remodeling
Lead sponsor: Biotronik SE & Co. KG
Sponsor class: INDUSTRY
First posted: 2012-10-22
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Intra-indivudual correlation coefficient r between stroke volume (SV) and stroke impedance (SZ).
timeFrame: Month 2
Secondary outcomes:
measure: Intra-individual correlation coefficient r between left-ventricular end-systolic volume (LVESV) and left-ventricular end-systolic impedance (LVESZ).
timeFrame: Month 2
Other outcomes:
measure: Intra-individual correlation coefficient r between stroke volume (SV) and stroke impedance (SZ).
timeFrame: Month 2
Locations:
city: Aalborg
country: Denmark
facility: Aalborg Sygehus, Kardiologisk Afdeling
city: Aarhus
country: Denmark
facility: Aarhus Universitetshospital, Hjertemedicinsk Afdeling B
city: Hellerup
country: Denmark
facility: Gentofte Hospital, Department P
city: Odense
country: Denmark
facility: Odense University Hospital, Hjertemedicinsk Afdeling B
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum NRW
city: Berlin
country: Germany
facility: Charité Campus Virchow-Klinik, Medizinische Klinik mit Schwerpunkt Kardiologie
city: Bernau
country: Germany
facility: Herzzentrum Brandenburg, Immanuel Klinikum
city: Bielefeld
country: Germany
facility: Klinikum Bielefeld Mitte
city: Bielefeld
country: Germany
facility: Evangelisches Krankenhaus
city: Essen
country: Germany
facility: Universitätsklinikum Essen, Westdeutsches Herzzentrum Essen
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover, Klinik für Kardiologie und Angiologie
city: Mönchengladbach
country: Germany
facility: Kliniken Maria Hilf GmbH, Innere Medizin II, Klinik für Kardiologie
city: München
country: Germany
facility: Klinikum der Universität München - Grosshadern
city: Nauen
country: Germany
facility: Havellandklinik Nauen
city: Reinbek
country: Germany
facility: Krankenhaus Reinbek St. Adolf-Stift, Innere Abt. Kardiologie
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg, Medizinische Klinik und Poliklinik I, Medizinische Intensiv- und Notfallmedizin
city: Ancona
country: Italy
facility: Azienda Ospedaliero Univesitaria, Ospedali Riuniti Umberto I- G.M. Lancisi- G. Salesi
city: Pisa
country: Italy
facility: Fondazione Toscana G. Monasterio
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
city: Zwolle
country: Netherlands
facility: Isala Klinieken, Hospital de Weezenlanden, Department of Cardiology
city: Zürich
country: Switzerland
facility: Universitätsspital Zürich
Study officials:
affiliation: Aalborg University, Aalborg University Hospital
name: Peter Sogaard, MD, PhD, Prof.
role: STUDY_CHAIR
affiliation: Herz- und Diabeteszentrum NRW, Bad Oeynhausen
name: Klaus-Jürgen Gutleben, MD, PhD
role: STUDY_CHAIR
References: