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

University of Adelaide1 site in 1 country20 target enrollmentJanuary 2013

ConditionsUncontrolled Hypertension

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Uncontrolled Hypertension
Sponsor: University of Adelaide
Enrollment: 20
Locations: 1
Primary Endpoint: Cardiac Function (evaluated by MRI)
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2013

End Date

October 2015

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of Adelaide

Responsible Party

Principal Investigator

Stephen Grant Worthley

Helpman Chair of Cardiovascular Medicine

University of Adelaide

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

Outcomes

Primary Outcomes

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