Renal Denervation for Uncontrolled Hypertension (RDNP-2012-02)

Baker Heart and Diabetes Institute

Status

Withdrawn

Conditions

Hypertension

Treatments

Device: Renal Denervation

Study type

Interventional

Funder types

Other

Identifiers

NCT02016573

1034397 (Other Grant/Funding Number)

070/12

Details and patient eligibility

About

This is a study investigating the safety and usefulness of the Renal Denervation Procedure in reducing high blood pressure in people whose blood pressure is not adequately controlled despite already being treated with 2 blood pressure lowering drugs. This study is designed to compare the effects renal denervation to a usual care group.

Full description

This is a phase 4 randomised control trial of renal denervation for the treatment of uncontrolled hypertension.

Previous studies have shown that the renal denervation procedure is safe and effective in reducing blood pressure.

A total of 100 participants with uncontrolled blood pressure, treated with two blood pressure lowering medications will be recruited into the study. Patients will be assigned to one of two groups. Participants in Group 1 will be assigned to undergo the renal denervation procedure. Participants in group 2 will undergo usual care, receiving additional antihypertensive medication in an attempt to reach blood pressure targets.

The duration of this study is 36 months.

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

BP ≥140/90 mmHg (or ≥130/80 mmHg for patients with diabetes)
concurrent treatment with 2 anti-hypertensive drugs

Exclusion criteria

renal artery anatomy ineligible for treatment
eGFR <15mL/min/1.73m2 (using MDRD formula)
individual has had myocardial infarction, unstable angina or cerebrovascular accident within 6 months of screening visit
female participants of child bearing potential must have negative pregnancy test prior to treatment