Using the baroloop device to treat resistant hypertension

Baroloop MCT - A Multicenter Trial of Safety and Performance of Baroloop

This study is testing if a new device called baroloop can help adults with stubborn high blood pressure that doesn’t get better with regular medications.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: neuroloop GmbH (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 4 sites (Münster, North Rhine-Westphalia and 3 other locations)
• Trial ID: NCT06518915 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety and efficacy of the baroloop system in treating adults with hypertension that does not respond adequately to conventional medication. Participants will have the baroloop device implanted and will undergo follow-up visits at specified intervals for device adjustments and assessments. The study will monitor for any major medical complications and measure changes in blood pressure, as well as gather information on participants' quality of life.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 years or older with persistent hypertension despite being on a stable regimen of three antihypertensive medications.

Not a fit: Patients who may not benefit from this study include those with anatomical limitations preventing access to the vagus nerve or those with a history of vagus nerve injury.

Why it matters

Potential benefit: If successful, this treatment could provide a new option for patients with resistant hypertension, potentially improving their blood pressure control and overall health.

How similar studies have performed: While the baroloop device represents a novel approach, similar interventions targeting the vagus nerve have shown promise in other studies.

Eligibility criteria

Inclusion Criteria:

1. Aged 18 years or older.
2. Persistent office systolic blood pressure (SBP) ≥ 140 mm Hg and diastolic blood pressure (DBP) \> 90 mm Hg on antihypertensive medicines on two visits separated by a minimum of four weeks.
3. 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.
4. Stable drug regimen of 3 antihypertensive medicines consisting of a reninangiotensin blocker (ACE) or Angiotensin II Receptor Blocker (ARBs), a calcium channel blocker (CCB), and a diuretic for 4 weeks at treatment.
5. Willingness and ability to comply with follow-up requirements.
6. Signed informed consent.

Exclusion Criteria:

1. 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).
2. Any patient with a history of injury to the vagus nerve or its branches (e.g., the recurrent laryngeal nerve).
3. Secondary causes of hypertension.
4. Calculated eGFR \< 30 mL/min/1.73m2.
5. Type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus (HbA1c \> 10%).
6. Requirement for chronic oxygen therapy or mechanical ventilation.
7. Untreated (no CPAP therapy) sleep apnea (AHI \> 15)
8. Morbid obesity, defined as Body Mass Index \>40 kg/m2 or arm circumference 46 cm.
9. Pacemaker and/or implantable defibrillators.
10. History of transient ischemic accident or cerebrovascular accident during six (6) months prior to screening.
11. Symptomatic carotid artery disease or \> 70% occlusion of either carotid artery; any carotid malformation or lesion, a carotid bruit or other abnormal carotid sound.
12. 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).
13. Limited mobility of the neck secondary to vertebral disease or prior vertebral surgery, including patients who wear a cervical support.
14. History of heart failure (NYHA class III-IV).
15. Cardiac arrythmias (atrial fibrillation, atrial flutter, etc.) that require anticoagulation if the condition interferes with a consistent measurement of blood pressure.
16. Unexplained syncope in the last 6 months.
17. History of bleeding disorders, thrombocytopenia, hemophilia, or significant anemia (hemoglobin (Hgb) \< 10 g/dl).
18. Current anticoagulation therapy (excluding antiplatelet therapy with aspirin as a sole therapy).
19. History of unresolved drug or alcohol use.
20. Active treatment of a psychiatric ailment.
21. Life expectancy of less than 12 months due to other disease.
22. Subject has a condition that, in the opinion of the investigator, precludes participation, including willingness to comply, with all follow-up procedures.
23. Participation in another clinical study for which follow-up is currently on-going.
24. Women who are pregnant
25. Resting heart rateof \< 45 beats/min s, confirmed at both baseline visits.
26. Baroreflex failure or autonomic neuropathy
27. Symptomatic, uncontrolled bradyarrhythmias
28. Atrioventricular block of any grade
29. Presence of a vagus stimulator
30. Patients who are likely to require magnetic resonance imaging (MRI) of the cervical area
31. Occupational exposure to high levels of non-ionizing radiation that may interfere with therapy
32. Patients with a limited ability to read, understand and execute adjustment procedures (for example, persons suffering from dementia).
33. Likely exposure to diathermy.

Where this trial is running

Münster, North Rhine-Westphalia and 3 other locations

• Clemenshospital Münster — Münster, North Rhine-Westphalia, Germany (Recruiting)
• Marienhaus Klinikum Mainz — Mainz, Rhineland-Westphalia, Germany (Recruiting)
• Städtisches Klinikum Dresden — Dresden, Saxony, Germany (Recruiting)
• UMC Utrecht — Utrecht, Utrecht, Netherlands (Recruiting)

Study contacts

• Study coordinator: Medical Scientific Affairs

Conditions Hypertension, Resistant to Conventional Therapy