Feasibility Study of Renal Denervation for the Treatment of Resistant Hypertension (SoundITV)

Sound Interventions

Status and phase: Unknown; Early Phase 1

Conditions: Uncontrolled Hypertension

Treatments: Device: Ultrasound-based Renal Denervation

Study type: Interventional

Funder types: Industry

Identifiers

NCT01865591

SITV-CL-0001

Details and patient eligibility

About

The aim of this study is to assess the potential therapeutic benefit of catheter-based renal sympathetic denervation using therapeutic unfocussed ultrasound in a single-arm feasibility trial.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Uncontrolled hypertension (defined as SBP ≥ 140 mmHg during 24Hr Ambulatory BP monitoring)
• Current treatment with ≥ 3 anti-hypertensive drugs (including at least one diuretic)
• Renal artery diameter ≥5mm by digital angiography
• Accessibility of renal vasculature

Exclusion criteria

• Estimated GFR < 45
• Type 1 Diabetes
• Known renovascular abnormalities (eg, renal artery stenosis, previous renal artery stenting or angioplasty)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Renal denervation

Experimental group

Description:

Subjects are treated with unfocussed ultrasound-based renal denervation and are maintained on baseline anti-hypertensive medications.

Treatment:

Device: Ultrasound-based Renal Denervation