Back to results

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

Primary Purpose

Uncontrolled Hypertension

Status

Unknown status

Phase

Not Applicable

Locations

Australia

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Uncontrolled Hypertension focused on measuring Uncontrolled hypertension, Renal denervation, Renal artery

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Royal Adelaide Hospital AdelaideRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Renal Denervation

Arm Description

Outcomes

Primary Outcome Measures

Cardiac Function (evaluated by MRI)

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

Secondary Outcome Measures

Renal Function (evaluated by MRI)

MRI Indices of Renal Function: Renal blood flow Renal perfusion Urinary protein

Cardiac Function

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

Full Information

NCT ID

NCT02164435

First Posted

June 12, 2014

Last Updated

June 12, 2014

Sponsor

University of Adelaide

1. Study Identification

Unique Protocol Identification Number

NCT02164435

Brief Title

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

Acronym

RDN

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2014

Overall Recruitment Status

Unknown status

Study Start Date

January 2013 (undefined)

Primary Completion Date

July 2014 (Anticipated)

Study Completion Date

October 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Adelaide

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Uncontrolled Hypertension

Keywords

Uncontrolled hypertension, Renal denervation, Renal artery

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Renal Denervation

Arm Type

Other

Intervention Type

Procedure

Intervention Name(s)

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

Primary Outcome Measure Information:

Title

Cardiac Function (evaluated by MRI)

Description

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

Time Frame

Baseline and 6 Months

Secondary Outcome Measure Information:

Title

Renal Function (evaluated by MRI)

Description

MRI Indices of Renal Function: Renal blood flow Renal perfusion Urinary protein

Time Frame

Baseline, 6 Months and 24 Months

Title

Cardiac Function

Description

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

Time Frame

Baseline and 24 Months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Stephen G Worthley, Prof

stephen.worthley@adelaide.edu.au

Facility Information:

Facility Name

Royal Adelaide Hospital Adelaide

City

Adelaide

State/Province

South Australia

ZIP/Postal Code

5000

Country

Australia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Joanne Nimmo

Phone

08 8222 2899

joanne.nimmo@health.sa.gov.au

First Name & Middle Initial & Last Name & Degree

Stephen Worthley, Prof

12. IPD Sharing Statement

Citations:

PubMed Identifier

29627741

Citation

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.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs