Clinical trial NCT02827032: Controlling and Lowering Blood Pressure With the MobiusHD™
Official title: Controlling and Lowering Blood Pressure With the MobiusHD™ - Defining Efficacy Markers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Keywords: Hypertension
Lead sponsor: Vascular Dynamics, Inc.
Sponsor class: INDUSTRY
First posted: 2016-07-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To perform post-market surveillance and evaluate the performance of the MobiusHD System in subjects with primary resistant hypertension.

Detailed description: The CALM-DIEM Trial is an open-label, prospective, multicenter study for patients who have been selected for treatment with the MobiusHD.

Eligibility criteria: Inclusion Criteria:

* Mean 24-hour systolic ABPM is ≥130 mmHg following at least 30 days on a stable antihypertensive medication regimen (no changes in medication or dose), and no more than 28 days prior to implantation.

Exclusion Criteria:

* Known or clinically suspected baroreflex failure or autonomic neuropathy

Substudy Eligibility Criteria: A maximum of 16 patients will be enrolled in the sub-study at one site (Universitair Medisch Centrum Utrecht)

Inclusion Criteria:

- Patients must be eligible for the main study and must have passed all CALM-DIEM study inclusion and exclusion criteria at time of screening

Exclusion Criteria:

* Use of anti-hypertensive drugs directly acting on the sympathetic nervous system that cannot be discontinued safely
* Underlying conditions that prohibit microneurography, performance of a Valsalva maneuver and/or magnetic resonance imaging

Primary outcomes:
measure: Evaluation of 24-hour systolic Ambulatory Blood Pressure Measurement (ABPM)
timeFrame: Baseline to ninety (90) days post treatment
Secondary outcomes:
measure: Incidence of Adverse Events
timeFrame: Baseline to three (3) years post treatment
Other outcomes:
measure: Substudy Outcome Measure - Change in sympathetic activity
timeFrame: Baseline to 90 days post treatment
measure: Substudy Outcome Measure - Change in sympathetic activity
timeFrame: Baseline to 90 days post treatment
measure: Substudy Outcome Measure - Change in sympathetic activity
timeFrame: Baseline to 90 days post treatment
measure: Substudy Outcome Measure - Change in baroreflex sensitivity
timeFrame: Baseline to 90 days post treatment
measure: Substudy Outcome Measure - Change in baroreflex sensitivity
timeFrame: Baseline to 90 days post treatment
measure: Substudy Outcome Measure - Change in baroreflex sensitivity
timeFrame: Baseline to 90 days post treatment
measure: Substudy Outcome Measure - Change in baroreflex sensitivity
timeFrame: Baseline to 90 days post treatment
Locations:
city: Mannheim
country: Germany
facility: Universitätsmedizin Mannheim
state: Baden-Württemberg
city: Frankfurt am Main
country: Germany
facility: CVC Frankfurt
state: Hesse
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
state: Lower Saxony
city: Cologne
country: Germany
facility: Uniklinik Köln
state: North Rhine-Westphalia
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf
state: North Rhine-Westphalia
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: Charite Berlin
city: Hamburg
country: Germany
facility: Asklepiod Klinik Hamburg
city: Homburg
country: Germany
facility: Universitatsklinikum des Saarlandes
city: The Hague
country: Netherlands
facility: HagaZiekenhuis
state: AA
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
state: EM
city: Maastricht
country: Netherlands
facility: Maastricht UMC+
state: HX
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Center
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht
city: Zwolle
country: Netherlands
facility: Isala
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital - Glasgo
state: Scotland
city: Glasgow
country: United Kingdom
facility: Golden Jubilee National Hospital
state: Scotland
city: Brighton
country: United Kingdom
facility: The Royal Sussex County Hospital
city: London
country: United Kingdom
facility: St. Bartholomew's Hospital
city: London
country: United Kingdom
facility: St. Thomas' Hospital
city: London
country: United Kingdom
facility: University College London Hospital
city: Manchester
country: United Kingdom
facility: Manchester University
Study officials:
References:
citation: van Kleef MEAM, Heusser K, Diedrich A, Oey PL, Tank J, Jordan J, Blankestijn PJ, Williams B, Spiering W. Endovascular baroreflex amplification and the effect on sympathetic nerve activity in patients with resistant hypertension: A proof-of-principle study. PLoS One. 2021 Nov 16;16(11):e0259826. doi: 10.1371/journal.pone.0259826. eCollection 2021.