HypertensionCALM-DIEMNCT02827032
Controlling and Lowering Blood Pressure With the MobiusHD™
A study testing MobiusHD™ in people with Hypertension, run by Vascular Dynamics, Inc. at 22 sites in 3 countries.
Trial summary
To perform post-market surveillance and evaluate the performance of the MobiusHD System in subjects with primary resistant hypertension. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertension
- What is being tested?
- MobiusHD™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 22 sitesin 3 countries
- Study dates
- Jul 2016to Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Patients must be eligible for the main study and must have passed all CALM-DIEM study inclusion and exclusion criteria at time of screening
Who cannot join
- 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)
- 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
Trial locations and contacts
22 sites in 3 countries.
22 sites in 3 countries
Germany9 sites, 1 recruiting
- Withdrawn
Charite Berlin
Berlin, 12200
- Completed
Uniklinik Köln
Cologne, North Rhine-Westphalia, 50937
- Completed
Universitätsklinikum Düsseldorf
Düsseldorf, North Rhine-Westphalia, 40225
- Recruiting
CVC Frankfurt
Frankfurt am Main, Hesse, 60389
Sabine de Bruijn, +49 69 97947653, s.debruijn@cvcfrankfurt.de
Horst Sievert, MD
- Completed
Asklepiod Klinik Hamburg
Hamburg
- Withdrawn
Medizinische Hochschule Hannover
Hanover, Lower Saxony, 30451
- Completed
Universitatsklinikum des Saarlandes
Homburg
- Withdrawn
Universitätsklinikum Schleswig-Holstein
Kiel, Schleswig-Holstein, 24105
- Withdrawn
Universitätsmedizin Mannheim
Mannheim, Baden-Wurttemberg, 68167
United Kingdom7 sites, 1 recruiting
- Withdrawn
The Royal Sussex County Hospital
Brighton, BN2 5BE
- Withdrawn
Queen Elizabeth University Hospital - Glasgo
Glasgow, Scotland, G51 4TF
- Withdrawn
Golden Jubilee National Hospital
Glasgow, Scotland, G81 4DY
- Completed
St. Bartholomew's Hospital
London, EC1A 7BE
- Withdrawn
St. Thomas' Hospital
London, SE1 7EH
- Recruiting
University College London Hospital
London, WC1E 6HX
Donna Moskal-Fitzpatrick, +44 207 679 9007 ext. 09007, donna.moskal@ucl.ac.uk
Bryan Williams
- Withdrawn
Manchester University
Manchester, M13 9PL
Netherlands6 sites, 1 recruiting
- Completed
Maastricht UMC+
Maastricht, HX, 6229
- Completed
St. Antonius Ziekenhuis
Nieuwegein, EM, 3435
- Active, not recruiting
Radboud University Medical Center
Nijmegen, 6525GA
- Completed
HagaZiekenhuis
The Hague, AA, 2545
- Recruiting
Universitair Medisch Centrum Utrecht
Utrecht, 3508 GA
Ingrid Klaassen, +31 88 7559954, i.klaassen@umcutrecht.nl
Corina Joosten, +31 88 7559954, C.A.M.Joosten@umcutrecht.nl
- Completed
Isala
Zwolle, 8025AB
About this study
Official title: Controlling and Lowering Blood Pressure With the MobiusHD™ - Defining Efficacy Markers
To perform post-market surveillance and evaluate the performance of the MobiusHD System in subjects with primary resistant hypertension.
Read the detailed description
The CALM-DIEM Trial is an open-label, prospective, multicenter study for patients who have been selected for treatment with the MobiusHD.
- Conditions
- Hypertension
- Being tested
- MobiusHD™
- Keywords
- Hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MobiusHD™Device
The MobiusHD device is a self-expanding nitinol implant that is delivered intravascularly to the internal carotid sinus via the delivery catheter.
| Study group | Role | What they receive |
|---|---|---|
| MobiusHD™ | Experimental | The MobiusHD device is a self-expanding nitinol implant that is delivered intravascularly to the internal carotid sinus via the delivery catheter. Receives: Device: MobiusHD™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of 24-hour systolic Ambulatory Blood Pressure Measurement (ABPM)
Change in the mean 24-hours systolic Ambulatory Blood Pressure
Measured: Baseline to ninety (90) days post treatment
Secondary outcomes (1)
Incidence of Adverse Events
Incidence of SAEs and UADEs reported from implantation through three years post treatment
Measured: Baseline to three (3) years post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionDec 2024 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vascular Dynamics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02827032
- Sponsor's protocol ID
- CRD0328
- Acronym
- CALM-DIEM
- Status last verified
- Oct 2023
- First submitted
- 6 Jul 2016
- Last updated
- 6 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Groenland EH, van Kleef MEAM, Hendrikse J, Spiering W, Siero JCW. The effect of endovascular baroreflex amplification on central sympathetic nerve circuits and cerebral blood flow in patients with resistant hypertension: A functional MRI study. Front Neuroimaging. 2022 Jul 25;1:924724. doi: 10.3389/fnimg.2022.924724. eCollection 2022.
PubMed 37555165van 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.
PubMed 34784359
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlling and Lowering Blood Pressure With the MobiusHD™ - Defining Efficacy Markers
- ClinicalTrials.gov ID
- NCT02827032
- Acronym / sponsor ID
- CALM-DIEM / CRD0328
- Conditions
- Hypertension
- Keywords
- Hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Vascular Dynamics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2016 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 11 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MobiusHD™ | Experimental | Device: MobiusHD™The MobiusHD device is a self-expanding nitinol implant that is delivered intravascularly to the internal carotid sinus via the delivery catheter. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
- Patients must be eligible for the main study and must have passed all CALM-DIEM study inclusion and exclusion criteria at time of screening
Key exclusion criteria (4 listed)
- 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)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MobiusHD™The MobiusHD device is a self-expanding nitinol implant that is delivered intravascularly to the internal carotid sinus via the delivery catheter. | Device | MobiusHD™ |
Primary outcome
Evaluation of 24-hour systolic Ambulatory Blood Pressure Measurement (ABPM)
Time frame: Baseline to ninety (90) days post treatment
Change in the mean 24-hours systolic Ambulatory Blood Pressure
1 secondary outcome
Incidence of Adverse Events
Time frame: Baseline to three (3) years post treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
- Derived from this study: PubMed 37555165Groenland EH, van Kleef MEAM, Hendrikse J, Spiering W, Siero JCW. The effect of endovascular baroreflex amplification on central sympathetic nerve circuits and cerebral blood flow in patients with resistant hypertension: A functional MRI study. Front Neuroimaging. 2022 Jul 25;1:924724. doi: 10.3389/fnimg.2022.924724. eCollection 2022.
- Derived from this study: PubMed 34784359van 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
22 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MobiusHD™ in people with Hypertension, run by Vascular Dynamics, Inc. at 22 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Germany, United Kingdom, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lisa Green (949.231.7602, lgreen@vasculardynamics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of 24-hour systolic Ambulatory Blood Pressure Measurement (ABPM) (time frame: Baseline to ninety (90) days post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02827032, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2023.