Device Based Therapy in Hypertension Trial (DEBuT-HT)

A Study of Baroreflex Hypertension Therapy in Refractory Hypertension

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

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Device: Rheos Baroreflex Hypertension Therapy System

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
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czech Republic
  • Hradec Kralove, Czech Republic
    • University Hospital Hradec Kralove
• Germany
  • Bad Oeynhausen, Germany
    • University Hospital Bad Oeynhausen
  • Berlin, Germany
    • Charite Campus Buch
  • Essen, Germany
    • Uniklinik Essen
  • Hannover, Germany
    • University Hospital Hannover
• Latvia
  • Riga, Latvia
    • Latvian Centre of Cardiology
• Netherlands
  • Maastricht, Netherlands
    • Academisch Ziekenhuis Maastricht
• Poland
  • Gdansk, Poland
    • Medical University of Gdansk
• Switzerland
  • Bern, Switzerland
    • Inselspital Bern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	4 months post implant
Demonstrate a 10 mmHg decrease from baseline (1-Month office cuff blood pressure) in systolic blood pressure after three months of incrementally optimized therapy.	4 months post implant

Collaborators and Investigators

• Sponsor: CVRx, Inc.
• Investigators: Study Director: Thomas Baal, PhD, CVRx, Inc.

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: July 1, 2003
• Primary Completion (ACTUAL): October 1, 2011
• Study Completion (ACTUAL): October 1, 2011

Study Registration Dates

• First Submitted: July 1, 2008
• First Submitted That Met QC Criteria: July 3, 2008
• First Posted (ESTIMATE): July 4, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): October 21, 2016
• Last Update Submitted That Met QC Criteria: October 19, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: High Blood Pressure; Refractory Hypertension; Drug Resistant Hypertension; Baroreflex Hypertension Therapy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 360004-001