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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02164435

Acronym

RDN

Enrollment

Registered

2014-06-16

Start date

2013-01-31

Completion date

2015-10-31

Last updated

2014-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uncontrolled Hypertension

Keywords

Uncontrolled hypertension, Renal denervation, Renal artery

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.

Interventions

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Cardiac Function (evaluated by MRI)	Baseline and 6 Months	MRI Indices of Cardiac Function * Myocardial mass and myocardial fibrosis * Atrial and ventricular ejection function * Myocardial perfusion * Arterial distensibility

Secondary

Measure	Time frame	Description
Renal Function (evaluated by MRI)	Baseline, 6 Months and 24 Months	MRI Indices of Renal Function: * Renal blood flow * Renal perfusion * Urinary protein
Cardiac Function	Baseline and 24 Months	MRI Indices of Cardiac Function * Myocardial mass and myocardial fibrosis * Atrial and ventricular ejection function * Myocardial perfusion * Arterial distensibility

Countries

Australia

Contacts

Primary ContactStephen G Worthley, Prof

stephen.worthley@adelaide.edu.au

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026