Heart Failure Clinical Trial
Official title:
Partial Left Ventricular Support in Advanced Heart Failure
Heart failure is a common condition, and the number of people with advanced disease continues to increase. We need new treatments that improve patients' symptoms and extend life. Recently the new CircuLite Synergy pump has come into use. It is the smallest pump manufactured to date and does not cover the full work of the heart, instead providing "partial" support. One interesting thing about this is that taking some strain off the heart might allow the muscle to repair and rebuild its own strength. This process is called reverse remodelling, and is the topic of this research. Our hypothesis is that "partial" support improves patients' symptoms and causes improvement in heart muscle function. We also want to examine the best techniques for assessing this, including new scanning and molecular tests, and study some practical aspects of the pump to do with blood clotting.
The CircuLite Synergy pump is a new minimally-invasive partial support left ventricular
assist device (LVAD) that pumps blood from the left atrium to the right subclavian artery.
Ex vivo pilot data suggests that the Synergy pump induces structural reverse remodelling,
which proposes the Synergy device as a new disease-modifying therapy. We will assess whether
the Synergy pump facilitates functional, structural and molecular LV reverse remodelling in
vivo; assess how this can be determined and predicted by analysis of circulating micro RNA
profiles and specific echocardiographic parameters; and evaluate the haematological
abnormalities associated with this new LVAD.
We will address these questions with a prospective, observational study comparing patients
implanted with the Synergy device with matched heart failure controls. The two study centres
will be Royal Brompton & Harefield NHS Foundation Trust (Harefield Hospital) and University
Hospitals Leuven, Belgium. We will recruit a total of 64 patients. The primary outcome will
be change in peak VO2 at 6 months. Secondary outcomes will include functional parameters,
profiling of circulating microRNA, multimodal echocardiographic assessment and comprehensive
assessment of platelet activation and coagulopathy.
We will quantify the LV reverse remodelling associated with partial support; define new echo
and microRNA markers of reverse remodelling for clinical use, with insights into underlying
pathophysiology; and describe the haematological profile of these patients to guide future
antiplatelet and anticoagulant therapy.
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Observational Model: Case Control, Time Perspective: Prospective
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