NCT01865253

Brief Summary

This is an observational proof of concept study investigating the safety and effectiveness of renal denervation to lower blood pressure in people whose blood pressure is not adequately controlled due to:

  • intolerance to antihypertensive medication
  • inability to take antihypertensive medication due to planned pregnancy
  • renal artery stenosis
  • chronic kidney disease
  • non-compliance to antihypertensive medication A total of 125 participants, 25 from each of the groups mentioned above will be recruited to the study. The duration of this study is 36 months.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for phase_4 hypertension

Timeline
Completed

Started May 2012

Typical duration for phase_4 hypertension

Geographic Reach
1 country

1 active site

Status
terminated

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

Study Start

First participant enrolled

May 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 27, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 30, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

November 5, 2018

Status Verified

November 1, 2018

Enrollment Period

2.8 years

First QC Date

May 27, 2013

Last Update Submit

November 1, 2018

Conditions

Hypertension

Keywords

renal denervationblood pressurecardiovascular risktarget organ damagesympathetic activitychronic kidney diseasenon-compliance

Outcome Measures

Primary Outcomes (1)

  • Change in average office blood pressure

    Change in systolic and diastolic average office blood pressure from baseline to 6 months post procedure

    baseline to 6 months post procedure

Secondary Outcomes (8)

  • Blood pressure control

    baseline to 6 months post procedure

  • Number of drugs required to reach target blood pressure

    baseline to 6 months post procedure

  • Time to achieve blood pressure target

    baseline to 6 months post procedure

  • Change in sympathetic nerve activity

    baseline to 6 months post procedure

  • Change in left ventricular structure and function

    baseline to 6 months post procedure

  • +3 more secondary outcomes

Study Arms (1)

Renal Denervation

EXPERIMENTAL

Renal Denervation treatment

Device: Renal Denervation

Interventions

Renal DenervationDEVICE

Renal Denervation

Also known as: Symplicity Renal Denervation Catheter
Renal Denervation

Eligibility Criteria

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

You may qualify if:

  • BP ≥140/90 mmHg (or ≥130/80 mmHg for patients with diabetes)
  • Intolerance to ≥2 antihypertensive drug classes
  • Inability to take Angiotensin-Converting-Enzyme Inhibitor (ACEI), Angiotensin II Receptor Blockers (ARBs) or Direct Renin inhibitors (DRIs) due to planned pregnancy
  • Renal artery stenosis
  • Chronic Kidney Disease

You may not qualify if:

  • renal artery anatomy ineligible for treatment
  • individual has had myocardial infarction, unstable angina or cerebrovascular accident within 6 months of screening visit
  • 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

MeSH Terms

Conditions

HypertensionRenal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Markus P Schlaich, MD

    Baker IDI Heart & Diabetes Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2013

First Posted

May 30, 2013

Study Start

May 1, 2012

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

November 5, 2018

Record last verified: 2018-11

Locations

AU(1)