NL-OMON54976
Completed
N/A
A First in Humans Study of Safety and Feasibility of baroloop: The baroloop Study - The baroloop Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- hypertension
- Sponsor
- neuroloop GmbH
- Enrollment
- 6
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial is onging in other countries
Investigators
Eligibility Criteria
Inclusion Criteria
- •Aged 18 years or older and less than 80 years of age.
- •Persistent office systolic blood pressure (SBP) \>\= 140 mm Hg or diastolic
- •blood pressure (DBP) \> 90 mm Hg on antihypertensive medicines on two visits
- •separated by a minimum of four weeks.
- •Mean 24\-hour systolic ABPM \>\= 130 mm Hg and mean 24\-hour diastolic ABPM \>\= 80
- •mm Hg conducted after direct observed therapy to confirm that antihypertensive
- •medicines were taken as prescribed during the ABPM measurement.
- •. Stable drug regimen of 4 antihypertensive medicines consisting of a
- •renin\-angiotensin blocker(ACE) or Angiotensin II Receptor Blocker (ARBs), a
- •calcium channel blocker (CCB), and a diuretic for 4 weeks at treatmenta
Exclusion Criteria
- •Any patient in whom access to the vagal nerve is .limited by the size of the
- •vagus (a size not compatible with the baroloop cuff).
- •. Any patient with a history of injury to the vagus nerve or its branches
- •(e.g., the recurrent laryngeal nerve).
- •Secondary causes of hypertension.
- •Calculated eGFR \< 30 mL/min/1\.73m2\.
- •Type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus (HbA1c
- •One or more episodes of orthostatic hypotension in the past year
- •Requirement for chronic oxygen therapy or mechanical ventilation.
- •Untreated (no CPAP therapy) sleep apnea (AHI \> 15\)
Outcomes
Primary Outcomes
Not specified
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