Renal Denervation in Patients with Uncontrolled Hypertension (SYMPLICITY HTN-3)

Study Status

Open to Enrollment

Study Description

The Symplicity HTN-3 Study is testing the effectiveness of a medical device in treating uncontrolled high blood pressure (hypertension).

The kidneys are an important regulator of blood pressure. Previous research has shown that disrupting the nerves of the kidney (“renal denervation”) may successfully decrease blood pressure.

This study is testing an experimental device called the Symplicity Catheter System, which provides catheter-based renal denervation, to determine if it is a safe and effective alternative for uncontrolled hypertension.  Men and women whose systolic (top) blood pressure is above 160 despite treatment with 3 or more blood pressure medications (including a diuretic) may be eligible for the study.

Study participants will be randomly assigned to one of two study groups:

  • Treatment Group: Intervention with the denervation procedure
  • Control Group: Will not undergo the denervation procedure

Two-thirds of participants will be randomized to the treatment group and one-third to the control group. Participants will not be told which group they are assigned to, and procedures will be followed to prevent participants from knowing which group they are in.

All participants will continue with their blood pressure medications and will be followed for the next 6 months, after which they will learn whether they received the real or control procedure.

Participants who received the control procedure will then have the option to receive the renal denervation. All participants will then be followed for an additional 30 months. Follow‐up visits will occur 1, 3, and 6 months after the procedure (real or sham), then every 6 months until study completion. Follow‐up visits will include a physical exam with blood pressure measurements, blood, and urine collection.

Disease Status and/or Stage

Hypertension

Sponsor

Medtronic Ardian

Key Eligibility

  • Men and women age 18 to 80
  • Systolic Blood Pressure ≥ 160 mmHg despite being on at least 3 antihypertensive drugs (1 of which is a diuretic)

Principal Investigator

Samuel Mann, MD

Contact

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Contact Us

For general inquiries, or if you need assistance finding a study, please contact:

Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
[email protected]

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