Intrathoracic Blood Volume in Heart Failure Patients Clinical Trial
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
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.
n/a
Time Perspective: Prospective