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

University of Adelaide

Status

Unknown

Conditions

Uncontrolled Hypertension

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT02164435

CI-12-044-AU-HT

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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