NCT02164435

Brief Summary

This is a prospective, single centre clinical investigation looking at short (6 months) and long term (24 months) changes in cardiac function and renal function in patients with drug-resistant hypertension post renal sympathetic denervation.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2013

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 12, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 16, 2014

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

June 16, 2014

Status Verified

June 1, 2014

Enrollment Period

1.5 years

First QC Date

June 12, 2014

Last Update Submit

June 12, 2014

Conditions

Uncontrolled Hypertension

Keywords

Uncontrolled hypertensionRenal denervationRenal artery

Outcome Measures

Primary Outcomes (1)

  • Cardiac Function (evaluated by MRI)

    MRI Indices of Cardiac Function * Myocardial mass and myocardial fibrosis * Atrial and ventricular ejection function * Myocardial perfusion * Arterial distensibility

    Baseline and 6 Months

Secondary Outcomes (2)

  • Renal Function (evaluated by MRI)

    Baseline, 6 Months and 24 Months

  • Cardiac Function

    Baseline and 24 Months

Study Arms (1)

Renal Denervation

OTHER
Procedure: Renal Denervation (EnligHTN™) Renal artery ablation with the EnligHTN™ Renal Denervation System.

Interventions

Renal Denervation (EnligHTN™) Renal artery ablation with the EnligHTN™ Renal Denervation System.PROCEDURE
Renal Denervation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject must be able and willing to comply with the required follow-up schedule
  • Therapeutic Goods Association approved indications for EnligHTN™ Renal Denervation System
  • Subject is ≥ 18 years of age at time of consent Subject has office SBP ≥ 160 mmHg (except for subjects with Diabetes Mellitus who must demonstrate an office SBP of ≥ 150 mm Hg) within 14 days of the procedure ◦Subject is taking ≥ 3 antihypertensive medications concurrently at maximum tolerated dose (this must include one diuretic) or subject has a documented intolerance to at least 2 out of the 4 major classes of anti-hypertensives (ACE/ARB, CCB, Diuretics, Beta Blockers and is unable to take 3 antihypertensive drugs.

You may not qualify if:

  • implanted cardiac device
  • intracranial metallic implants
  • claustrophobia -Gadolinium-specific: estimated GFR \<60 mls/min (usual clinical cut-off is \<30 mls/min).
  • Adenosine-specific:
  • asthma / reactive airways disease
  • \>first degree atrioventricular block
  • concomitant use of dipyridamole or theophylline consumption of caffeine within 48 hours of proposed investigation
  • Subject has an identified cause of secondary hypertension
  • Subject has an estimated GFR \<45 mL/min per 1.73 m2 using the MDRD formula
  • Subject has undergone prior renal angioplasty, indwelling renal stents, and/or aortic stent grafts
  • Subject has haemodynamically significant valvular heart disease
  • Subject has a life expectancy less than 12 months, as determined by the PI
  • Subject is participating in another clinical study Subject is pregnant, nursing, or of childbearing potential and is not using adequate contraceptive methods
  • Subject has renal arteries with diameter(s) \< 4 mm in diameter

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Adelaide Hospital Adelaide

Adelaide, South Australia, 5000, Australia

RECRUITING

Related Publications (1)

  • Delacroix S, Chokka RG, Nelson AJ, Wong DT, Pederson S, Nimmo J, Rajwani A, Williams K, Teo KS, Worthley SG. Effects of renal sympathetic denervation on myocardial structure, function and perfusion: A serial CMR study. Atherosclerosis. 2018 May;272:207-215. doi: 10.1016/j.atherosclerosis.2018.03.022. Epub 2018 Mar 10.

    PMID: 29627741DERIVED

Central Study Contacts

Stephen G Worthley, Prof

CONTACT

stephen.worthley@adelaide.edu.au

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Helpman Chair of Cardiovascular Medicine

Study Record Dates

First Submitted

June 12, 2014

First Posted

June 16, 2014

Study Start

January 1, 2013

Primary Completion

July 1, 2014

Study Completion

October 1, 2015

Last Updated

June 16, 2014

Record last verified: 2014-06

Locations

AU(1)