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

Uncontrolled Hypertension Clinical Trial

— RDN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02164435
• Other study ID #: CI-12-044-AU-HT
• Status: Recruiting
• Phase: N/A
• First received: June 12, 2014
• Last updated: June 12, 2014
• Start date: January 2013
• Est. completion date: October 2015

Study information

• Verified date: June 2014
• Source: University of Adelaide
• Contact: Stephen G Worthley, Prof
• Email: stephen.worthley[@]adelaide.edu.au
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 2015
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Uncontrolled Hypertension

Intervention

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

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital Adelaide	Adelaide	South Australia

Sponsors (1)

Lead Sponsor	Collaborator
University of Adelaide

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Renal Function (evaluated by MRI)	MRI Indices of Renal Function: Renal blood flow; Renal perfusion; Urinary protein	Baseline, 6 Months and 24 Months	Yes
Secondary	Cardiac Function	MRI Indices of Cardiac Function; Myocardial mass and myocardial fibrosis; Atrial and ventricular ejection function; Myocardial perfusion; Arterial distensibility	Baseline and 24 Months	No