Congestive Cardiac Failure Clinical Trial
Official title:
Renal Artery Denervation in Chronic Heart Failure- Pilot
Heart failure is a common condition with debilitating symptoms and a poor prognosis.
Patients with heart failure have a massively overactive sympathetic nervous system which
attempts to compensate for their poorly functioning heart. This ultimately has only
detrimental effects.
One of the principle mediators for this sympathetic response is found in the nerve cells in
the kidneys. Whilst a significant proportion of medications used to treat heart failure act
on these harmful pathways, none target the kidney sympathetic-nerve cells specifically.
Additionally, because of their multiple sites of action these drugs all have side effects.
A new procedure that has recently been developed for the treatment of high blood pressure is
renal denervation. This involves inserting a small catheter through the femoral artery and
passing it to the kidney artery under x-ray guidance. From there, using radiofrequency
waves, the sympathetic nerves within the kidney can be destroyed.
The investigators anticipate that this procedure will have a significant positive effect on
patients with heart failure and aim to perform a pilot safety study on 7 individuals with
advanced heart failure to assess its safety and effectiveness. The investigators hypothesise
that renal artery denervation will lead to significant clinical and biochemical improvements
in patients with marked heart failure.
One of the key physiological changes seen in heart failure patients is overactivity of the
sympathetic nervous system. This is a homeostatic response produced by the body in an
attempt to compensate for a poorly functioning heart and the resultant underperfused
tissues. In acute heart failure this has a positive effect but in chronic heart failure, the
long standing sympathetic overactivity causes multiple undesirable side effects including
profound vasoconstriction, increased sodium reabsorption by the kidneys, renin release and
decreased renal blood flow. Afferent and efferent sympathetic chains in the renal artery
play an important role in the mediation of this response.
Current management of heart failure principally hinges on drugs that attempt to attenuate or
interrupt this response via renin angiotensin system, adrenoreceptors or the renal tubules.
These drugs have multiple side effects, partly because of their multiple sites of action.
None directly target the sympathetic discharge at its source.
The development of renal artery denervation opens a unique opportunity for potentially
longlasting relief of this intense renal sympathetic over-activity. The technique has a
current role in the management of resistant hypertension where it has shown very favourable
results with minimal side effects. The investigators envisage that this technique could also
be highly beneficial to patients with heart failure by directly interrupting this
sympathetic overactivity. This initial study involving 7 patients is a pilot safety study to
assess this potential.
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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