None listed
Conditions
Brief summary
Sudden cardiac death accounts for 26-45% of cardiovascular deaths in patients on dialysis. Sympathetic overactivity from the diseased kidneys is thought to contribute substantially to the high risk of cardiac events. The Australasian Kidney Trials Network (AKTN) have initiated a feasibility study of beta blocker therapy (BLOCADE) to test the tolerability of carvidolol in dialysis patients, with the view to a full study investigating sympathetic blockade on cardiac events in dialysis patients. Renal sympathetic denervation by radiofrequency ablation is a new novel alternative to medical therapy to reduce sympathetic overactivity. It would be logical to compare ß blocker therapy to renal denervation in dialysis patients in a head to head study. However, it is necessary to test the feasibility of renal denervation in this high risk group and to obtain appropriate data that would accurately inform end points and surrogate markers of the endpoints. The surrogate end points are changes in blood pressure, reduction in anti-hypertensive medications, changes in heart rate, changes in sympathetic nerve activity measured directly by microneurography and indirectly by changes in circulating neuro-hormones. This application is for a feasibility study to inform scientific committee of the AKTN to allow a well designed intervention study to reduce sudden cardiac death in a very high risk population, that is patients on dialysis.
Interventions
The denervation procedure itself involves an endovascular catheter-based approach to disrupt renal sympathetic nerves using radiofrequency (RF) ablation. This is a single intervention, which takes approximately 40 minutes for the proceedure in the cardiology angiography suite. This procedure will by performed by Assoc Prof G Wilkins. Data will be collected at baseline (over a week prior to the procedure) and following renal denervation at 1, 3, and 12 months. The impact of renal denervation will
The denervation procedure itself involves an endovascular catheter-based approach to disrupt renal sympathetic nerves using radiofrequency (RF) ablation. This is a single intervention, which takes approximately 40 minutes for the proceedure in the cardiology angiography suite. This procedure will by performed by Assoc Prof G Wilkins. Data will be collected at baseline (over a week prior to the procedure) and following renal denervation at 1, 3, and 12 months. The impact of renal denervation will be measured by changes in blood pressure; cardiac function by way of holter monitoring and echocardiographic measurement of left ventricular function; multiunit postganglionic sympathetic nerve activity (MSNA) will be recorded through the use of microneurography in the peroneal nerve; circulating plasma catecholamines as an indirect marker of sympathetic activity
Sponsors
University of Otago
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
8 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Age > 18 and able to give consent. On dialysis for at least 3 months. Clinically stable with no evidence of fluid overload, recent myocardial ischaemia or heart attack. Blood pressure > 130/90 despite medications. They must have intact native renal kidneys
Exclusion criteria
Patients with significant renovascular abnormalities will not permitted to undergo the intervention. Anatomic abnormalities including multiple main renal arteries, short length main renal arteries, failed renal transplant, are exclusion criteria. Inability to give consent.
Outcome results
None listed