Clinical trial NCT00710190: Device Based Therapy in Hypertension Trial
Official title: A Study of Baroreflex Hypertension Therapy in Refractory Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Drug Resistant Hypertension
Refractory Hypertension
High Blood Pressure
Baroreflex Hypertension Therapy
Lead sponsor: CVRx, Inc.
Sponsor class: INDUSTRY
First posted: 2008-07-04
Enrollment: 46
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: 4 months post implant
measure: Demonstrate a 10 mmHg decrease from baseline (1-Month office cuff blood pressure) in systolic blood pressure after three months of incrementally optimized therapy.
timeFrame: 4 months post implant
Secondary outcomes:
Other outcomes:
Locations:
city: Hradec Kralove
country: Czech Republic
facility: University Hospital Hradec Kralove
city: Bad Oeynhausen
country: Germany
facility: University Hospital Bad Oeynhausen
city: Berlin
country: Germany
facility: Charité Campus Buch
city: Essen
country: Germany
facility: Uniklinik Essen
city: Hannover
country: Germany
facility: University Hospital Hannover
city: Riga
country: Latvia
facility: Latvian Centre of Cardiology
city: Maastricht
country: Netherlands
facility: Academisch Ziekenhuis Maastricht
city: Gdansk
country: Poland
facility: Medical University of Gdansk
city: Bern
country: Switzerland
facility: Inselspital Bern
Study officials:
affiliation: CVRx, Inc.
name: Thomas Baal, PhD
role: STUDY_DIRECTOR
References: