Clinical trial NCT02164435: Effects of Renal Sympathetic Denervation on the Cardiac and Renal Functions in Patients With Drug-resistant Hypertension Through MRI Evaluation
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
Overall status: UNKNOWN
Phase: NA
Conditions: Uncontrolled Hypertension
Keywords: Uncontrolled hypertension
Renal denervation
Renal artery
Lead sponsor: University of Adelaide
Sponsor class: OTHER
First posted: 2014-06-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Cardiac Function (evaluated by MRI)
timeFrame: Baseline and 6 Months
Secondary outcomes:
measure: Renal Function (evaluated by MRI)
timeFrame: Baseline, 6 Months and 24 Months
measure: Cardiac Function
timeFrame: Baseline and 24 Months
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital Adelaide
state: South Australia
Study officials:
References:
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.