Renal Denervation in Patients With Uncontrolled Hypertension (Symplicity HTN-2)

Medtronic Vascular106 enrolled

Overview

An international, multi-center, prospective, randomized, controlled study of the safety and effectiveness of renal denervation in patients with uncontrolled hypertension.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

106

Conditions

Uncontrolled Hypertension

Interventions

Renal Denervation (Symplicity® Renal Denervation System)DEVICE

Catheter-based renal denervation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * systolic blood pressure \>=160mmHg (\>=150 mmHg for type 2 diabetics); * on 3 or more antihypertensive medications * \>= 18 and =\< 85 years of age. Exclusion Criteria: * renal artery abnormalities * eGFR \< 45mL/min * MI, angina, CVA within 6 months * Type 1 diabetes * ICD or pacemaker, or any other metallic implant not compatible with MRI * others

Locations (20)

Alfred Hospital

Melbourne, Australia

Vienna General Hospital

Vienna, Austria

Outcomes

Primary Outcomes

Office Systolic Blood Pressure Reduction

The primary effectiveness endpoint is change in Office Systolic Blood Pressure (SBP) from baseline to 6 months post-randomization.

Time frame: Baseline to 6 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.