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

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Device: Renal Denervation; Other: Sham control

• Registration Number: NCT02444442
• Lead Sponsor: Baker Heart and Diabetes Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-05-12
• Study First Submitted QC: 2015-05-13
• Study First Posted: 2015-05-14
• Study Start: 2015-06
• Primary Completion: 2020-04
• Study Completion: 2020-04
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-13
• Last Update Posted: 2023-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Renal Denervation	Renal Denervation	participants randomised to undergo renal denervation
Sham control	Sham control	participants randomised to undergo sham procedure

Primary Outcome Measures

Name	Time	Method
Change in ambulatory systolic blood pressure between groups	6 months post procedure	Difference in mean ambulatory systolic daytime blood pressure between RDN group and sham-control group at 6 month follow up.

Secondary Outcome Measures

Name	Time	Method
Change in mean 24h systolic blood pressure between groups	6 months post procedure	Change in mean 24h systolic blood pressure between RDN group and sham-control group at 6 month follow up.
Change in mean night time systolic blood pressure between groups	6 months post procedure	Change in mean night time systolic blood pressure between RDN group and sham-control group at 6 month follow up.
Change in mean office systolic blood pressure between groups	6 months post procedure	Change in mean office systolic blood pressure between RDN group and sham-control group at 6 month follow up.

Trial Locations

Locations (1)

Baker IDI Heart & Diabetes Institute; 🇦🇺 Melbourne, Victoria, Australia