Sham Controlled Clinical Trial of Renal Denervation in Patients With Resistant Hypertension

Baker Heart and Diabetes Institute105 enrolled

Overview

The purpose of this study is to assess the efficacy of catheter-based renal denervation in reducing blood pressure in patients with resistant hypertension compared to a sham procedure. Patients will be randomized to RDN or sham control in a 2:1 ratio. All participants will be switched to a single pill triple combination treatment prior to the procedure. A total of 105 patients will be recruited into the study, 70 patients in the RDN arm and 35 patients in the sham control arm. The duration of this study is 36 months.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

105

Conditions

Hypertension

Interventions

Renal DenervationDEVICE

Deliberate disruption of the renal nerves via radio frequency energy delivery to renal arteries.

Sham controlOTHER

Arterial access only. No delivery of radio frequency energy to renal arteries.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * systolic office BP ≥140mmHg and ambulatory day time average ≥135mmHg despite concurrent treatment with ≥3 anti-hypertensive drugs Exclusion Criteria: * renal artery anatomy ineligible for treatment * eGFR \<15mL/min/1.73m2 (using MDRD calculation) * myocardial infarction, unstable angina or cerebrovascular accident within 3 months of screening visit * life expectancy of \<12 months * female participants of childbearing potential must have negative pregnancy test prior to treatment

Locations (1)

Baker IDI Heart & Diabetes Institute

Melbourne, Victoria, Australia

Outcomes

Primary Outcomes

Change in ambulatory systolic blood pressure between groups

Difference in mean ambulatory systolic daytime blood pressure between RDN group and sham-control group at 6 month follow up.

Time frame: 6 months post procedure

Secondary Outcomes

Change in mean 24h systolic blood pressure between groups

Change in mean 24h systolic blood pressure between RDN group and sham-control group at 6 month follow up.

Time frame: 6 months post procedure

Change in mean night time systolic blood pressure between groups

Change in mean night time systolic blood pressure between RDN group and sham-control group at 6 month follow up.

Time frame: 6 months post procedure

Change in mean office systolic blood pressure between groups

Change in mean office systolic blood pressure between RDN group and sham-control group at 6 month follow up.

Time frame: 6 months post procedure

Data from ClinicalTrials.gov

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