Blood pressure changes over 3 years in a resistant severe hypertensive crisis population
Project Details
Aim: The aim of the project is to identify patients who have severe resistant hypertension and look at their natural progression over a historical three year time period in order to compare them to similar patients who have severe resistant hypertension who were treated with renal denervation (RDN). The research questions is: "Does RDN therapy in addition to at least three anti-hypertensive medication reduce systolic BP and/or diastolic blood pressure significantly compared to at least three anti-hypertensive medication with no RDN therapy in a severe resistant hypertensive crisis patient population?"
Overview: The primary objective is to use the Patron data to as a historical control group to be matched to the RDN registry data. We are looking to match patients from the Patron database that are prescribed three or more anti-hypertensive medications yet still have a systolic blood pressure (BP) of ≥ 180 mmHg and/or a diastolic BP of ≥ 120 mmHg to clinically similar patients from the RDN registry as a baseline cohort of patients who have not received RDN therapy. This indirect comparison of the single arm RDN registry to the general clinical practice (Patron data) will be used to inform a Medical Services Advisory Committee (MSAC) application for a new MBS item number for the renal denervation (RDN) procedure. As there are no RCTs in this severe hypertensive patient population, the best available evidence of RDN in this patient population is a single arm registry. MSAC advisors have advised we do an indirect comparison to an external control group for our MSAC application.
A secondary objective is to determine the prevalence of hypertensive crisis in a real-world patient population. This will be used to inform the budget impact analyses in the MSAC application of the eligible patient cohort for RDN in Australia. It will also contribute to the public health knowledge on hypertensive crisis and the extent to which Australian patients and the Australian healthcare system are impacted.
Project Lead: Michelle Hill
Lead Organisation: Medtronic Australasia Pty Ltd
Patron ID: PAT1058