Heart Failure Clinical Trial
Official title:
Studies of Empagliflozin and Its Cardiovascular, Renal and Metabolic Effects in Patients With Diabetes Mellitus (or Pre-diabetes) and Heart Failure (SUGAR-DM-HF)
The investigators hypothesise that empagliflozin 10mg daily will have haemodynamic, cardiac, and renal benefits compared to placebo over 36 weeks in heart failure patients with type 2 diabetes (or pre-diabetes), leading to measurable improvements in clinical measures of cardiac structure and function (LVESVI, and LV strain) as well as renal blood flow.
The results of the EMPA-REG OUTCOME trial on CVD outcomes and heart failure hospitalisation
suggests that empagliflozin works quickly to lessen CVD mortality and reduce heart failure
hospitalisations in patients with diabetes and existing cardiovascular disease. The lack of
effect on non-fatal MI and stroke would suggest limited impact on atherothrombotic
mechanisms. It is important to understand the mechanisms by which empagliflozin is acting in
more detail, in order that the drug can be more widely targeted at patient groups that might
benefit most; particularly patients with heart failure and diabetes (or pre-diabetes) (as
discussed in the rationale).
The investigators have hypothesised, in a detailed published review, that the benefit derives
from the specific effects of sodium-glucose linked transporter-2 (SGLT2) inhibition on renal
sodium and glucose handling, leading to both diuresis and improvements in diabetes-related
maladaptive renal arteriolar responses. These haemodynamic and renal effects are likely to be
beneficial in patients with clinical or subclinical cardiac dysfunction. The net result of
these processes is an improvement in cardiac systolic and diastolic function and, thereby, a
lower risk of heart failure hospitalisation (HFH) and sudden cardiac death.
The investigators have therefore designed the present trial to perform a comprehensive
clinical trial to interrogate in detail the effects of empagliflozin on specific pathways
(inclusive of cardiac and renal effects) in patients with type 2 diabetes (or pre-diabetes)
and heart failure.
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