Device Based Therapy in Hypertension Trial (DEBuT-HT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00710190
Recruitment Status : Completed
First Posted : July 4, 2008
Last Update Posted : October 21, 2016
Information provided by (Responsible Party):
CVRx, Inc.

Brief Summary:
The purpose of this study is to demonstrate the safety and efficacy of the Rheos Baroreflex Hypertension Therapy System in patients with refractory hypertension.

Condition or disease Intervention/treatment Phase
Hypertension Device: Rheos Baroreflex Hypertension Therapy System Not Applicable

Detailed Description:
The DEBuT-HT trial will investigate the safety and efficacy of Rheos Baroreflex Hypertension Therapy(TM) in patients with refractory hypertension despite full pharmacologic therapy. Enrolled patients will be carefully assessed prior to receiving a permanently implanted Rheos System. Once the system is implanted, these patients will be followed closely for 1 month to establish baseline information. The Rheos System will be programmed "ON" at the 1 month follow-up and incrementally increased at 2 and 3-month follow-up evaluations. An assessment of safety and efficacy will be made at the 4-month follow-up. Enrolled patients will be followed annually thereafter.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study of Baroreflex Hypertension Therapy in Refractory Hypertension
Study Start Date : July 2003
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Arm Intervention/treatment
Experimental: Rheos Implant Device: Rheos Baroreflex Hypertension Therapy System
This therapy uses implantable device-based electrical activation of the carotid sinus baroreflex to control blood pressure.

Primary Outcome Measures :
  1. Demonstrate the safety of Rheos(TM) Baroreflex Hypertension Therapy (TM) System by evaluating all adverse events and estimating the system and procedure related adverse event rate. [ Time Frame: 4 months post implant ]
  2. Demonstrate a 10 mmHg decrease from baseline (1-Month office cuff blood pressure) in systolic blood pressure after three months of incrementally optimized therapy. [ Time Frame: 4 months post implant ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Be at least 21 years of age.
  • Have been assessed to have bilateral carotid bifurcations located at or below C3 - C4.
  • Have blood pressure greater than or equal to 160 mmHg systolic and/or greater than or equal to 90 mmHg diastolic despite at least two months of full therapy with at least three (3) anti-hypertensive medications, of which at least one (1) must be a diuretic.
  • Must be certified by the investigator as compliant to taking full doses of medications.
  • Have signed an approved informed consent form for participation in this study.

Exclusion Criteria:

  • Have been diagnosed with:

    • Baroreflex failure or significant orthostatic hypotension
    • Cardiac brady arrhythmias or chronic atrial fibrillation
  • Have carotid atherosclerosis determined by ultrasound or angiographic evaluation with a stenosis of greater than 50%.
  • Have prior surgery or radiation in either carotid sinus region
  • Currently have implanted electrical medical devices such as cardiac pacing, defibrillation or neurologic stimulation systems.
  • Are pregnant or contemplating pregnancy during the 4-month follow-up period.
  • Are on dialysis
  • Have hypertension secondary to a treatable cause
  • Have clinically significant cardiac valvular disease
  • Are unable to comply with protocol requirements.
  • Are unlikely to survive the protocol follow-up period
  • Are enrolled in another concurrent clinical trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00710190

Czech Republic
University Hospital Hradec Kralove
Hradec Kralove, Czech Republic
University Hospital Bad Oeynhausen
Bad Oeynhausen, Germany
Charité Campus Buch
Berlin, Germany
Uniklinik Essen
Essen, Germany
University Hospital Hannover
Hannover, Germany
Latvian Centre of Cardiology
Riga, Latvia
Academisch Ziekenhuis Maastricht
Maastricht, Netherlands
Medical University of Gdansk
Gdansk, Poland
Inselspital Bern
Bern, Switzerland
Sponsors and Collaborators
CVRx, Inc.
Study Director: Thomas Baal, PhD CVRx, Inc.

Additional Information:
Responsible Party: CVRx, Inc. Identifier: NCT00710190     History of Changes
Other Study ID Numbers: 360004-001
First Posted: July 4, 2008    Key Record Dates
Last Update Posted: October 21, 2016
Last Verified: October 2016

Keywords provided by CVRx, Inc.:
Drug Resistant Hypertension
Refractory Hypertension
High Blood Pressure
Baroreflex Hypertension Therapy

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases