- Are you between 18 and 85 years of age?
- Are you suffering from uncontrolled blood pressure ≥140mmHg despite treatment with more than 3 anti-hypertensive drugs
People that have resistant hypertension are encouraged to partake in this study (uncontrolled blood pressure despite already being treated with three or more blood pressure lowering drugs). This research project aims to assess how effective a medical treatment called renal denervation is in reducing blood pressure when compared to a sham control (placebo) procedure
Renal denervation (RDN) is a medical procedure which disrupts the activity of nerves in the wall of the blood vessel leading to the kidney (renal artery) by delivering low-level radiofrequency (RF i.e. radiowave) energy to this vessel. The procedure is performed with a medical device called the multi-electrode Spyral® RDN Catheter System. It includes the spyral multi-electrode catheter which features four electrodes that deliver simultaneous radiofrequency energy into the renal artery wall. Both left and right renal arteries are treated. Disrupting the nerves supplying the kidney using RDN has been shown in a number of trials to effectively reduce blood pressure in patients with severe hypertension. This system has been approved for commercial use in the European Union and by the Therapeutic Goods Administration of Australia (TGA) for RDN.
A total of 105 patients will participate in this project. The study will follow a ‘randomised control’ design in a 2:1 ratio. Therefore, two thirds of the patients in this study will be randomly assigned to have the renal denervation procedure (70 patients) while the other third (35 patients) will be assigned to undergo a sham control procedure where no energy is being delivered during the procedure. This will be a double-blind study which means that neither the participant nor the study doctor will know which treatment (renal denervation or placebo control) has been administered. However, in certain circumstances the study doctor can find out which treatment has been received.
Participants will then be switched to a single pill, triple combination medication (Exforge HCT 5/160/12.5mg or Exforge HCT 10/320/25mg) plus Spironolactone 12.5-25mg (or Moxonidine 0.4-0.6mg if Spironolactone is not indicated or tolerated). This will be done prior to the procedure.
Participation in this project will be for 3 years with approximately 10 visits spread over that time. The study visits will be conducted at the Alfred Hospital.
This project has been initiated by Professor Markus Schlaich and is supported by a grant from the National Health and Medical Research Council of Australia. The ethical aspects of this research project have been approved by the HREC of The Alfred Hospital (Project number 002/15).
To register your interest in the AUSHAM study, please contact Louise Hammond on 8532-1872, or firstname.lastname@example.org
|Download the flyer with more specific information about this study|
(Source: Baker IDI Heart and Diabetes Institute)