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Device Based Therapy in Hypertension Trial (DEBuT-HT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CVRx, Inc.
ClinicalTrials.gov Identifier:
NCT00710190
First received: July 1, 2008
Last updated: October 28, 2011
Last verified: October 2011
  Purpose

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 Intervention
Hypertension
Device: Rheos Baroreflex Hypertension Therapy System

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study of Baroreflex Hypertension Therapy in Refractory Hypertension

Resource links provided by NLM:


Further study details as provided by CVRx, Inc.:

Primary Outcome Measures:
  • The purpose of this clinical investigation is to demonstrate the safety and efficacy of the Rheos Baroreflex Hypertension Therapy System in patients with refractory hypertension. [ Time Frame: end of trial ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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: 2009 ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: July 2003
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Rheos Baroreflex Hypertension Therapy System
    This therapy uses implantable device-based electrical activation of the carotid sinus baroreflex to control blood pressure.
Detailed Description:

The DEBuT-HT trial will investigate the safety and efficacy of Rheos Baroreflex Hypertension TherapyT 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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00710190

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

Additional Information:
No publications provided

Responsible Party: CVRx, Inc.
ClinicalTrials.gov Identifier: NCT00710190     History of Changes
Other Study ID Numbers: 360004-001
Study First Received: July 1, 2008
Last Updated: October 28, 2011
Health Authority: Germany: Ethics Commission
Netherlands: Independent Ethics Committee

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

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 19, 2014