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

NCT02444442 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2023-09-14

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Renal Denervation

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

OTHER

Sham control

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

Sponsors & Collaborators

  • Baker Heart and Diabetes Institute

    lead OTHER

Principal Investigators

  • Markus P Schlaich, Professor · Laboratory Head, Neurovascular Hypertension and Kidney Disease (Baker IDI)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2020-04-30
Completion
2020-04-30

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02444442 on ClinicalTrials.gov