Intrathoracic Bloodvolume Measurement by Contrast Enhanced Ultrasound: Validation of the Technique and Evaluation as a Measurement of Response to Cardiac Resynchronization Therapy: a Pilot Study
Summary Rationale: Cardiac resynchronisation therapy (CRT) with biventricular pacemakers and implantable cardiac defibrillators (ICD) has proven to be a valuable therapy in selected patients with systolic heart failure, ameliorating both morbidity and mortality. However, with current selection criteria and implant technique, about 20 to 30 % of patients remain non-responders. Non-responders might be due to failing selection criteria or methodology in casu echocardiography. Moreover, the definition of response to CRT is unequivocal and there is a need for a simple and reproducible measure of response with low inter- and intra-observer variability.
Primary objectives: This study evaluates the correlation between intrathoracic blood volume (ITBV) measured by contrast enhanced ultrasound (CEUS) and magnetic resonance imaging (MRI), as well as the feasibility to use intrathoracic blood volume as a predictor for response to CRT.
Study design: a prospective nonrandomized pilot study Study population: patients with heart failure New York Heart Association (NYHA) class III or IV, a left ventricular ejection fraction equal to or less than 35% and a QRS-duration equal to or more than 0.12 seconds who are referred to our centre for implantation of a CRT-P or CRT-D device.
Intervention: No specific intervention will be performed. Main study parameters: correlation between intrathoracic bloodvolume measured by CEUS and MRI, correlation between LVEF measured by CEUS and by standard 2D ultrasound (biplane methods of discs), change in intrathoracic blood volume as a response to CRT.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: at baseline a clinical examination, laboratory analysis, cardiopulmonary exercise testing, echocardiography and cardiac magnetic resonance imaging will be performed. All of these examinations will be repeated at 3-months follow-up except for the cardiac magnetic resonance imaging. All examinations, except for the MRI, are part of the standard workup in our hospital for patients undergoing implantation of a CRT device. Data needed for the purpose of this study, will be acquired by offline image analysis with dedicated software.
Intrathoracic Blood Volume in Heart Failure Patients
|Study Design:||Time Perspective: Prospective|
|Official Title:||Intrathoracic Bloodvolume Measurement by Contrast Enhanced Ultrasound: Validation of the Technique and Evaluation as a Measurement of Response to Cardiac Resynchronization Therapy: a Pilot Study|
- a. change in ITBV measured by CEUS before and after CRT [ Time Frame: two years anticipated ] [ Designated as safety issue: No ]
- b. correlation of ITBV measured by CEUS and MRI before CRT [ Time Frame: two years anticipated ] [ Designated as safety issue: No ]
- a. correlation between LVEF estimated with CEUS and standard contrast 2D ultrasound [ Time Frame: two years anticipated ] [ Designated as safety issue: No ]
- b. correlation between LVEF estimated with CEUS and MRI [ Time Frame: two years anticipated ] [ Designated as safety issue: No ]
|Study Start Date:||June 2012|
|Study Completion Date:||July 2015|
|Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01735838
|Catharina Hospital Eindhoven|
|Eindhoven, Netherlands, 4194 TR|
|Principal Investigator:||I.H.F. Herold, MD||Catharina Hospital Eindhoven|