Renal Denervation for Resistant Hypertension (RDNP-2012-01)

Baker Heart and Diabetes Institute

Status and phase

Terminated

Phase 4

Conditions

Hypertension

Treatments

Device: Renal Denervation

Study type

Interventional

Funder types

Other

Identifiers

NCT01865240

008/12

NHMRC (Other Grant/Funding Number)

Details and patient eligibility

About

This is a study investigating the effectiveness of renal denervation in lowering blood pressure in people whose blood pressure is not adequately controlled despite treatment with 3 or more blood pressure lowering drugs. The study is designed to compare the effects of renal denervation to a usual care group receiving additional blood pressure lowering drugs.

Full description

Previous studies have shown that the renal denervation procedure is safe and effective in reducing blood pressure in patients with resistant hypertension. A total of 100 participants with uncontrolled blood pressure, treated with three or more blood pressure lowering medications will be recruited into the study. Patients will be assigned to one (1) of two (2) groups with the aim of attaining blood pressure control. Participants in group 1 will be assigned to renal denervation, participants in group 2 will receive additional antihypertensive medication according to current guidelines and best practice in an attempt to reach blood pressure targets.

Enrollment

5 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

systolic BP ≥140mmHg or ≥130mmHg for patients with diabetes
concurrent treatment with ≥3 anti-hypertensive drugs

Exclusion criteria

renal artery anatomy ineligible for treatment
eGFR <15mL/min/1.73m2 (using Modification of Diet in Renal Disease (MDRD) calculation)
female participants of childbearing potential must have negative pregnancy test prior to treatment