Effects of Renal Sympathetic Denervation on the Cardiac and Renal Functions in Patients With Drug-resistant Hypertension Through MRI Evaluation (RDN)

June 12, 2014 updated by: Stephen Grant Worthley, University of Adelaide
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Recruiting
        • Royal Adelaide Hospital Adelaide
        • Contact:
        • Principal Investigator:
          • Stephen Worthley, Prof

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Standard CMR exclusions;

    • 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
    • EnligHTN™ Renal Denervation System exclusion criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Renal Denervation
Procedure: Renal Denervation (EnligHTN™) Renal artery ablation with the EnligHTN™ Renal Denervation System.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac Function (evaluated by MRI)
Time Frame: Baseline and 6 Months

MRI Indices of Cardiac Function

  • Myocardial mass and myocardial fibrosis
  • Atrial and ventricular ejection function
  • Myocardial perfusion
  • Arterial distensibility
Baseline and 6 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Renal Function (evaluated by MRI)
Time Frame: Baseline, 6 Months and 24 Months

MRI Indices of Renal Function:

  • Renal blood flow
  • Renal perfusion
  • Urinary protein
Baseline, 6 Months and 24 Months
Cardiac Function
Time Frame: Baseline and 24 Months

MRI Indices of Cardiac Function

  • Myocardial mass and myocardial fibrosis
  • Atrial and ventricular ejection function
  • Myocardial perfusion
  • Arterial distensibility
Baseline and 24 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Adelaide

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Anticipated)

July 1, 2014

Study Completion (Anticipated)

October 1, 2015

Study Registration Dates

First Submitted

June 12, 2014

First Submitted That Met QC Criteria

June 12, 2014

First Posted (Estimate)

June 16, 2014

Study Record Updates

Last Update Posted (Estimate)

June 16, 2014

Last Update Submitted That Met QC Criteria

June 12, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CI-12-044-AU-HT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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