Renal Denervation for Complicated Hypertension (RDNP-2012-03)

Baker Heart and Diabetes Institute

Status and phase: Terminated; Phase 4

Conditions: Hypertension

Treatments: Device: Renal Denervation

Study type: Interventional

Funder types: Other

Identifiers

NCT01865253

1034397 (Other Grant/Funding Number)

087/12

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

Renal Denervation

Experimental group

Description:

Renal Denervation treatment

Treatment:

Device: Renal Denervation