Controlling And Lowering blood pressure with the MobiusHD device: STudying effects in A Randomized Trial.

Phase 2

Completed

• Conditions: drug resistant high blood pressure; resistant hypertension; 10057166

• Registration Number: NL-OMON47214
• Lead Sponsor: Vascular Dynamics, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

Screening:
1. Aged 18-70 years;
2. Diagnosed with resistant hypertension;
3. A mean systolic 24-hour ambulatory blood pressure of 135-170 mmHg following at least 30 days on a stable antihypertensive medication regimen (no changes in medications or dose).;Baseline:
1. A mean systolic 24-hour ambulatory blood pressure of 135-170 mmHg after washout of all antihypertensive medications.

Exclusion Criteria

Screening:
1. An inability to provide written informed consent;
2. Taking more than 4 antihypertensive medications;
3. Taking medications co-indicated for hypertension and a comorbidity that cannot be safely stopped for the antihypertensive medication washout periods (examples include beta-blockers) or taking other medications that cause hypotension (i.e. SGLT2 inhibitors for the treatment of diabetes mellitus) that cannot be safely switched/stopped;
4. Currently taking centrally acting agonists such as clonidine, moxonidine, or methyl dopa;
5. White coat hypertension, defined as >20% difference between an average of 3 consecutive systolic OBP measurements and mean systolic 24-hour ABP;
6. Patient with a history of hypertensive crisis in the past 6 months;
7. Known or clinically suspected baroreflex failure or autonomic neuropathy;
8. Known significant aortoiliac or common femoral artery disease that will prohibit safe femoral access, or determination upon femoral pulse assessment and examination of inguinal anatomy that femoral access is contraindicated;
9. Hypertension secondary to an identifiable cause other than treated sleep apnea (e.g., hyperaldosteronism, renal artery stenosis, pheochromocytoma, Cushing's syndrome, coarctation of the aorta, hyper- or hypothyroidism and intracranial tumor);
10. Treatable cause of hypertension including, but not limited to, improper BP measurement, volume overload and pseudotolerance (excessive sodium intake, volume retention from kidney disease, inadequate diuretic therapy), drug-induced or other causes (non-adherence, inadequate doses, inappropriate combinations, NSAIDs, COX-2 inhibitors, cocaine, amphetamines, or other drugs, sympathomimetics, oral contraceptives (confirmed cause of hypertension), adrenocortical steroids, cyclosporine, tacrolimus, erythropoietin, excessive licorice (including some chewing tobacco), ephedra, ma haung, bitter orange; and excessive alcohol intake;
11. Arm circumference >46 cm and/or BMI >=40 kg/m2;
12. Chronic atrial fibrillation, or intermittent atrial fibrillation with one or more episode(s) within the last twelve (12) months;
13. History of bleeding complications with dual antiplatelet therapy in the past, or has known uncorrected bleeding diathesis, or has history of Heparin Induced Thrombocytopenia (HIT);
14. Current or planned use of chronic anticoagulation therapy, including vitamin K antagonists and novel oral anticoagulants (apixaban, rivaroxaban, dabigatran and edoxaban).
15. Peptic ulcer disease with documented active ulcer, or gastrointestinal bleeding within the last year;
16. History of allergy to nickel, or allergy to contrast media that cannot be managed medically;
17. Persistent symptomatic orthostatic hypotension (>20/10 mmHg after 5 minutes of standing upright);
18. Syncope documented to be related to changes in BP within the last six (6) months;
19. History of myocardial infarction, or unstable angina within the past six (6) months;
20. History of cerebral vascular accident within the past year, and NIHSS >5 or mRS >1, or any prior stroke with permanent neurologic defect or any intracranial bleed;
21. Chronic kidney disease (Glomerular filtration rate (GFR) calculated by the Modification of Diet in Renal Disease equation <45 ml/min);
22. Prior carotid surgery, therapeutic radiation, or endovascular stent placement in either carotid region;
23. Severe v

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary efficacy endpoint is the difference in the change in mean systolic<br /><br>24-hour ambulatory blood pressure - in subjects after antihypertensive<br /><br>medication washout - from baseline to 90 days post-randomization, between the<br /><br>treatment arm and the sham arm.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary efficacy endpoints are differences in a) ambulatory and office blood<br /><br>pressure measurements (on and off medication), b) antihypertensive medication<br /><br>dosages, c) pathophysiology markers, and d) patient eand organ outcome markers<br /><br>from baseline through 180 days post-randomization, between the treatment and<br /><br>sham arms.<br /><br><br /><br>Safety endpoints are a) differences in the rate of serious adverse clinical<br /><br>events, including death, any stroke, carotid interventions, and/or myocardial<br /><br>infarction, from baseline to 30 days post-randomization, between the treatment<br /><br>and sham arms. </p><br>