Uncontrolled HypertensionHDNCT05352425
Effect of the MobiusHD® in Renal Hemodialysis Subjects With Uncontrolled Hypertension
A study testing MobiusHD in people with Uncontrolled Hypertension, run by Vascular Dynamics, Inc..
Trial summary
This is a prospective, multi-center, open-label clinical trial intended to evaluate the safety and benefit of the MobiusHD® system in renal hemodialysis subjects with uncontrolled hypertension. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Uncontrolled 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
- 0 participants
- Where
- No sites listed yet
- Study dates
- 31 May 2022to 10 Oct 2022
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 21 years or above
- End Stage Renal Disease subjects receiving renal hemodialysis at least 3 months prior to procedure
- Hypertension that is unresponsive to medical therapy of at least 3 anti-hypertensive medication classes
- Deemed an acceptable candidate for the implant procedure by the investigator
- Adequacy of the carotid anatomy for treatment with the MobiusHD implant based on non-invasive carotid duplex and CTA imaging, and invasive carotid angiography
Who cannot join
- Known or clinically suspected baroreflex failure or autonomic neuropathy
- History of intradialytic hypotension within the past 3 months
- Secondary cause of hypertension except treated obstructive sleep apnea syndrome
- BMI ≥ 45 kg/m2
- Presence of atherosclerotic plaque in the intended side for implantation as determined by carotid duplex
About this study
Official title: A Study Assessing the Effect of the MobiusHD® Implant in Renal Hemodialysis Subjects Presented With Uncontrolled Hypertension
This is a prospective, multi-center, open-label clinical trial intended to evaluate the safety and benefit of the MobiusHD® system in renal hemodialysis subjects with uncontrolled hypertension.
Read the detailed description
Renal hemodialysis patients with uncontrolled hypertension will be considered for the study. Subjects who meet initial screening requirements will undergo non-invasive imaging of the carotid anatomy to assess adequacy of the anatomy to allow placement of the MobiusHD® device. Eligible subjects will receive an implant placed in the internal carotid artery.
Following implantation of the device, subjects will be followed for 60 months.
- Conditions
- Uncontrolled Hypertension
- Being tested
- MobiusHD
- Keywords
- Uncontrolled Hypertension, End Stage Renal Disease, MobiusHD
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MobiusHDDevice
The MobiusHD® device is a nickel-titanium device that is implanted in the internal carotid sinus using a minimally invasive approach.
| Study group | Role | What they receive |
|---|---|---|
| MobiusHD | Experimental | Each subject enrolled in the study will undergo implantation of the MobiusHD® device Receives: Device: MobiusHD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of intradialytic hypotension (IDH)
Incidence of intradialytic hypotension between baseline and 6 months
Measured: 6 months
Major adverse neurological and cardiovascular events (MANCE)
Incidence of MANCE events between baseline and 6 months
Measured: 6 months
Change in 44-hour ambulatory blood pressure measurements (ABPM)
Change in 44-hour ABPM between baseline and 6 months
Measured: 6 months
Change in rate of blood pressure related hospitalizations
Change in rate of blood pressure related hospitalizations between baseline and 6 months
Measured: 6 months
Change in Quality of Life (QoL), assessed by the London Evaluation of Illness (LEVIL) questionnaire
Changes in the London Evaluation of Illness (LEVIL) questionnaire between baseline and 6 months. The scores on the LEVIL range from 0 to 100 Units on a Scale. A higher unit score indicates a better outcome.
Measured: 6 months
Change in Quality of Life (QoL), assessed by the Kidney Disease Quality of Life (KDQOL-36) questionnaire
Changes in the Kidney Disease Quality of Life (KDQOL-36) questionnaire between baseline and 6 months. The KDQOL-36 compares patients to others of the same age, gender, and diabetes status and is measured on by Units on a Scale. The higher a patient's average is above the mean indicates a better outcome.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start31 May 2022
- Primary completion10 Oct 2022
- Study completion10 Oct 2022
Why it stopped: Sponsor decided to not pursue study at this time
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uncontrolled 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vascular Dynamics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05352425
- Sponsor's protocol ID
- CRD0597, CRD0597_CAN
- Acronym
- HD
- Status last verified
- May 2023
- First submitted
- 1 Apr 2022
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Assessing the Effect of the MobiusHD® Implant in Renal Hemodialysis Subjects Presented With Uncontrolled Hypertension
- ClinicalTrials.gov ID
- NCT05352425
- Acronym / sponsor ID
- HD / CRD0597, CRD0597_CAN
- Conditions
- Uncontrolled Hypertension
- Keywords
- Uncontrolled Hypertension, End Stage Renal Disease, MobiusHD
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor decided to not pursue study at this time
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vascular Dynamics, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 May 2022 (actual)
- Primary completion
- 10 Oct 2022 (actual)
- Study completion
- 10 Oct 2022 (actual)
- First posted
- 28 Apr 2022 (actual)
- 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.
This is a prospective, multi-center, open-label clinical trial intended to evaluate the safety and benefit of the MobiusHD® system in renal hemodialysis subjects with uncontrolled hypertension.
Detailed description
Renal hemodialysis patients with uncontrolled hypertension will be considered for the study. Subjects who meet initial screening requirements will undergo non-invasive imaging of the carotid anatomy to assess adequacy of the anatomy to allow placement of the MobiusHD® device. Eligible subjects will receive an implant placed in the internal carotid artery.
Following implantation of the device, subjects will be followed for 60 months.
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: MobiusHDEach subject enrolled in the study will undergo implantation of the MobiusHD® device |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 21 years or above
- End Stage Renal Disease subjects receiving renal hemodialysis at least 3 months prior to procedure
- Hypertension that is unresponsive to medical therapy of at least 3 anti-hypertensive medication classes
- Deemed an acceptable candidate for the implant procedure by the investigator
- Adequacy of the carotid anatomy for treatment with the MobiusHD implant based on non-invasive carotid duplex and CTA imaging, and invasive carotid angiography
Key exclusion criteria (5 listed)
- Known or clinically suspected baroreflex failure or autonomic neuropathy
- History of intradialytic hypotension within the past 3 months
- Secondary cause of hypertension except treated obstructive sleep apnea syndrome
- BMI ≥ 45 kg/m2
- Presence of atherosclerotic plaque in the intended side for implantation as determined by carotid duplex
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 |
|---|---|---|
| MobiusHDThe MobiusHD® device is a nickel-titanium device that is implanted in the internal carotid sinus using a minimally invasive approach. | Device | MobiusHD |
Primary outcome
Incidence of intradialytic hypotension (IDH)
Time frame: 6 months
Incidence of intradialytic hypotension between baseline and 6 months
Major adverse neurological and cardiovascular events (MANCE)
Time frame: 6 months
Incidence of MANCE events between baseline and 6 months
Change in 44-hour ambulatory blood pressure measurements (ABPM)
Time frame: 6 months
Change in 44-hour ABPM between baseline and 6 months
Change in rate of blood pressure related hospitalizations
Time frame: 6 months
Change in rate of blood pressure related hospitalizations between baseline and 6 months
Change in Quality of Life (QoL), assessed by the London Evaluation of Illness (LEVIL) questionnaire
Time frame: 6 months
Changes in the London Evaluation of Illness (LEVIL) questionnaire between baseline and 6 months. The scores on the LEVIL range from 0 to 100 Units on a Scale. A higher unit score indicates a better outcome.
Change in Quality of Life (QoL), assessed by the Kidney Disease Quality of Life (KDQOL-36) questionnaire
Time frame: 6 months
Changes in the Kidney Disease Quality of Life (KDQOL-36) questionnaire between baseline and 6 months. The KDQOL-36 compares patients to others of the same age, gender, and diabetes status and is measured on by Units on a Scale. The higher a patient's average is above the mean indicates a better outcome.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing MobiusHD in people with Uncontrolled Hypertension, run by Vascular Dynamics, Inc..
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 5 inclusion and 5 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: withdrawn, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of intradialytic hypotension (IDH) (time frame: 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 May 2023.