Renal Denervation for Complicated Hypertension

Phase 4TerminatedNCT01865253

Baker Heart and Diabetes Institute23 enrolled

Overview

This is an observational proof of concept study investigating the safety and effectiveness of renal denervation to lower blood pressure in people whose blood pressure is not adequately controlled due to: * intolerance to antihypertensive medication * inability to take antihypertensive medication due to planned pregnancy * renal artery stenosis * chronic kidney disease * non-compliance to antihypertensive medication A total of 125 participants, 25 from each of the groups mentioned above will be recruited to the study. The duration of this study is 36 months.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hypertension

Interventions

Renal DenervationDEVICE

Renal Denervation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * BP ≥140/90 mmHg (or ≥130/80 mmHg for patients with diabetes) * Intolerance to ≥2 antihypertensive drug classes * Inability to take Angiotensin-Converting-Enzyme Inhibitor (ACEI), Angiotensin II Receptor Blockers (ARBs) or Direct Renin inhibitors (DRIs) due to planned pregnancy * Renal artery stenosis * Chronic Kidney Disease Exclusion Criteria: * renal artery anatomy ineligible for treatment * individual has had myocardial infarction, unstable angina or cerebrovascular accident within 6 months of screening visit * female participants of childbearing potential must have negative pregnancy test prior to treatment

Locations (1)

Baker IDI Heart & Diabetes Institute

Melbourne, Victoria, Australia

Outcomes

Primary Outcomes

Change in average office blood pressure

Change in systolic and diastolic average office blood pressure from baseline to 6 months post procedure