NCT02444442

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Jun 2015

Longer than P75 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 14, 2015

Completed
18 days until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

September 14, 2023

Status Verified

September 1, 2023

Enrollment Period

4.8 years

First QC Date

May 12, 2015

Last Update Submit

September 13, 2023

Conditions

Hypertension

Keywords

Renal denervationBlood pressureCardiovascular riskTarget organ damageSympathetic activityNon-compliance

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months post procedure

Secondary Outcomes (3)

  • Change in mean 24h systolic blood pressure between groups

    6 months post procedure

  • Change in mean night time systolic blood pressure between groups

    6 months post procedure

  • Change in mean office systolic blood pressure between groups

    6 months post procedure

Other Outcomes (10)

  • Change in percentage of patients achieving BP target between groups

    6 months post procedure

  • Change in percentage of patients with an ambulatory systolic BP reduction ≥5mmHg between groups

    6 months post procedure

  • Change in percentage of patients with an office systolic BP reduction ≥10mmHg between groups

    6 months post procedure

  • +7 more other outcomes

Study Arms (2)

Renal Denervation

ACTIVE COMPARATOR

participants randomised to undergo renal denervation

Device: Renal Denervation

Sham control

SHAM COMPARATOR

participants randomised to undergo sham procedure

Other: Sham control

Interventions

Renal DenervationDEVICE

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

Renal Denervation
Sham controlOTHER

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

Sham control

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • systolic office BP ≥140mmHg and ambulatory day time average ≥135mmHg despite concurrent treatment with ≥3 anti-hypertensive drugs

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baker IDI Heart & Diabetes Institute

Melbourne, Victoria, 3004, Australia

Location

Related Publications (1)

  • Pisano A, Iannone LF, Leo A, Russo E, Coppolino G, Bolignano D. Renal denervation for resistant hypertension. Cochrane Database Syst Rev. 2021 Nov 22;11(11):CD011499. doi: 10.1002/14651858.CD011499.pub3.

    PMID: 34806762DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Markus P Schlaich, Professor

    Laboratory Head, Neurovascular Hypertension and Kidney Disease (Baker IDI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2015

First Posted

May 14, 2015

Study Start

June 1, 2015

Primary Completion

April 1, 2020

Study Completion

April 1, 2020

Last Updated

September 14, 2023

Record last verified: 2023-09

Locations

AU(1)