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Clinical Trials/NL-OMON54976
NL-OMON54976CompletedNot Applicable

A First in Humans Study of Safety and Feasibility of baroloop: The baroloop Study - The baroloop Study

neuroloop GmbH0 sites6 target enrollmentStarted: TBDLast updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
6
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Trial is onging in other countries

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18 to 99 (—)

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
  • •diuretic and spironolactone for 4 weeks at treatment. If spironolactone is not
  • •tolerated, the regimen must include instead the addition of further diuretic
  • •therapy with either eplerenone, amiloride, higher-dose thiazide/thiazide-like
  • •diuretic or a loop diuretic, or the addition of bisoprolol or doxazosin. If
  • •none of these medicines are tolerated, then patients on a 3-drug regimen may be
  • •. The Investigator has confirmed that the patient has already tried and/or is
  • •not suitable for treatment with currently CE-marked device-based therapies for
  • •resistant hypertension as an alternative to baroloop therapy.
  • •Negative pregnancy test for women of child-bearing age
  • •Willingness and ability to comply with follow-up requirements.
  • •Signed informed consent.

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)
  • •Morbid obesity, defined as Body Mass Index >40 kg/m2 or arm circumference 46
  • •Pacemaker and/or implantable defibrillators.
  • •History of transient ischemic accident or cerebrovascular accident during six
  • •(6) months prior to screening.
  • •Symptomatic carotid artery disease or > 70% occlusion of either carotid
  • •artery ; any carotid malformation or lesion, a carotid bruit or other abnormal
  • •carotid sound.
  • •. Prior surgery, radiation therapy or scarring in the neck in the region of the
  • •carotid artery (e.g., patients with a tracheostomy, extensive thymectomy or
  • •thyroid surgery).
  • •. Limited mobility of the neck secondary to vertebral disease or prior
  • •vertebral surgery, including patients who wear a cervical support.
  • •History of heart failure (NYHA class III-IV or ejection fraction < 30%),
  • •myocardial infarction, unstable angina, coronary bypass or coronary angioplasty
  • •during six (6) months prior to screening.
  • •Cardiac arrythmias (atrial fibrillation, atrial flutter, etc.) that require
  • •anticoagulation or interfere with a consistent measurement of blood pressure.
  • •women of childbearing age are excluded for participation in this trial
  • •Syncope in the last 6 months.
  • •History of bleeding disorders, thrombocytopenia, hemophilia or significant
  • •anemia (hemoglobin (Hgb) < 10 gm/dl).
  • •Current anticoagulation therapy (excluding antiplatelet therapy with aspirin
  • •as a sole therapy).
  • •Works night shifts.
  • •History of unresolved drug or alcohol use.
  • •Active treatment of a psychiatric ailment.
  • •Life expectancy of less than 12 months due to other disease.
  • •Subject has a condition that, in the opinion of the investigator, precludes
  • •participation, including willingness to comply, with all follow-up procedures.
  • •Participation in another clinical study for which follow-up is currently
  • •. Baroreflex failure or autonomic neuropathy
  • •. Symptomatic, uncontrolled bradyarrhythmias
  • •. Atrioventricular block of any grade
  • •. Patients who are treated with Pacemaker and/or implantable defibrillators
  • •. Presence of a vagus stimulator
  • •. Patients who expect to require magnetic resonance imaging (MRI) of the
  • •cervical area
  • •. Occupational exposure to high levels of non-ionizing radiation that may
  • •interfere with therapy
  • •. Patients with a limited ability to read, understand and execute adjustment
  • +2 more not shown

Investigators

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