Resistant HypertensionNCT02926495
Subcutaneous Median Nerve Neuromodulation For Drug-Treatment Resistant Hypertension.
A study testing eCoin System in people with Resistant Hypertension, run by Valencia Technologies Corporation.
Trial summary
Hypertension is a serious public health issue, affecting approximately 30% of adults. Hypertension greatly contributes to the risk for heart disease and stroke, both among the top three leading causes of death in the Americas, Europe, and Asia. Read more about this study
- Who is it for?
- Ages 30 to 74 years
- Conditions the study is for
- Resistant Hypertension
- What is being tested?
- eCoin System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Dec 2018
- 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 30 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individual is ≥30 and <75 years of age at the time of randomization.
- Individual is receiving a stable medication regimen including maximally tolerated doses of 3 or more anti-hypertensive medications of different classes, of which one must be a diuretic (with no changes for a minimum of 4 weeks prior to screening) that is expected to be maintained without changes for at least 6 months post randomization.
- Individual has an office systolic BP ≥140 mmHg and ≤180 mmHg and diastolic BP ≥80 mmHg and ≤110 mmHg measured at an initial screening visit and a confirmatory baseline visit.
- Individual has a 24 hour ambulatory systolic BP of ≥135 mmHg and ≤175 mmHg at baseline.
Who cannot join
- Individual in whom medications are expected to change in the next 9 months (6 months post randomization).
- Individual does not agree to have all study procedures performed, and is not competent and willing to provide written, informed consent to participate in this clinical study.
- Individual has type 1 diabetes mellitus or type 2 diabetes mellitus with an A1C ≥ 9%.
- Individual has experienced, within one year of the screening visit, a myocardial infarction, hospitalized unstable angina pectoris, hospitalized heart failure, TIA or a cerebrovascular accident.
- Individual has a scheduled or planned surgery, cardiovascular intervention, or dialysis in the next six months.
- Individual has hemodynamically significant valvular heart disease for which reduction of BP would be considered hazardous.
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- Individual has any serious medical condition with a prognosis of <2 years.
- Individual has significant anemia (hemoglobin <100g/L), thrombocytopenia (platelets <100x10(9) /L) or a severe bleeding disorder eg. hemophilia.
- Individual has known secondary hypertension including primary aldosteronism (other than associated with obstructive sleep apnea).
- Individual has pulmonary hypertension.
- Individual requires chronic oxygen support or mechanical ventilation (e.g., tracheostomy, CPAP, BiPAP) other than nocturnal respiratory support for sleep apnea.
- Individual is pregnant, nursing or planning to become pregnant.
- Individual has known or suspected history of medication non-compliance.
- Individual has known unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable to comply with study follow-up requirements.
- Individual has undergone renal denervation or baroreflex activation therapy.
- Individual has an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2.
- Individual has another implantable stimulation device including a cardiac pacemaker, ICD, spinal cord stimulator, brain stimulator, vagus nerve stimulator, peripheral nerve stimulator, or cochlear implant.
- Individual is scheduled to have an MRI.
- Individual is currently enrolled in another investigational drug or device trial that has not reached its primary endpoint.
- Individual is working nights or is on a rotating work schedule.
- Individual has an arm circumference too large or small to allow accurate blood pressure measurement with available devices.
- Individual has a history of carpal tunnel syndrome/wrist surgery or other pre-existing compression or non-compression neuropathy in the forearm, wrist or hands that is incompatible with device placement.
About this study
Hypertension is a serious public health issue, affecting approximately 30% of adults. Hypertension greatly contributes to the risk for heart disease and stroke, both among the top three leading causes of death in the Americas, Europe, and Asia. While most treated individuals with hypertension are controlled on medication, diet and exercise, an estimated 12% are resistant to conventional medical intervention. Alternative effective treatments are still needed for this hypertensive patient population to mitigate the risk and incidence of mortality and morbidity.
This original Investigational Device Application is for a study intended to confirm the safety and efficacy of bilateral subcutaneous median nerve stimulation using the eCoin system to treat resistant hypertension. The eCoin device delivers electrical stimulation pulses to the median nerve from a small coin sized device placed under the skin of the distal anterior forearm. The implant delivers a weekly 30 minute treatment based on previous studies showing a long lasting and cumulative effect. The safety and efficacy of eCoin therapy has previously been demonstrated in a multinational, randomized, double-blind, sham-controlled study in New Zealand, Taiwan and Canada.
This trial is a multi-center, prospective, double-blind, 1:1 randomized sham-controlled study of the safety and effectiveness of eCoin median nerve neuromodulation in subjects with drug-treatment resistant hypertension. The eCoin neuromodulation device will be implanted subcutaneously in the right and left forearms of patients with uncontrolled hypertension despite treatment with 3 or more antihypertensive agents. After a 4 week implant healing period, subjects will be 1:1 randomized into either a treatment or control group. One half of the subjects have their devices activated (treatment) and the other half undergo a sham activation (control) to maintain participant blinding to their treatment allocation. During the six months post-randomization, the eCoin is ON in the treatment group and OFF in the control group.
- Conditions
- Resistant Hypertension
- Being tested
- eCoin System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eCoin SystemDevice
Median nerve neurostimulator.
| Study group | Role | What they receive |
|---|---|---|
| Treatment (ON) | Active comparator | Not described Receives: Device: eCoin System |
| Control (OFF) | Sham comparator | Not described Receives: Device: eCoin System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Change in 24-hr SBP Between Groups at 6 Months
The difference in 24-hour ambulatory systolic blood pressure change from baseline to 6 months post-randomization between the eCoin neuromodulation ON (Treatment) and eCoin neuromodulation OFF (Control) groups.
Measured: From baseline to 6 months post-randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2016 (estimated)
- Study startNov 2016 (estimated)
- Primary completionMay 2018 (estimated)
- Study completionDec 2018 (estimated)
Why it stopped: The study was stopped before start because the project was not fully-funded.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resistant 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valencia Technologies Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02926495
- Sponsor's protocol ID
- G160188
- Status last verified
- Feb 2017
- First submitted
- 3 Oct 2016
- Last updated
- 23 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subcutaneous Median Nerve Neuromodulation For Drug-Treatment Resistant Hypertension.
- ClinicalTrials.gov ID
- NCT02926495
- Acronym / sponsor ID
- G160188
- Conditions
- Resistant Hypertension
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was stopped before start because the project was not fully-funded.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Valencia Technologies CorporationIndustry (pharma, biotech, devices)
- Study start
- Nov 2016 (estimated)
- Primary completion
- May 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 6 Oct 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.
Hypertension is a serious public health issue, affecting approximately 30% of adults. Hypertension greatly contributes to the risk for heart disease and stroke, both among the top three leading causes of death in the Americas, Europe, and Asia. While most treated individuals with hypertension are controlled on medication, diet and exercise, an estimated 12% are resistant to conventional medical intervention. Alternative effective treatments are still needed for this hypertensive patient population to mitigate the risk and incidence of mortality and morbidity.
This original Investigational Device Application is for a study intended to confirm the safety and efficacy of bilateral subcutaneous median nerve stimulation using the eCoin system to treat resistant hypertension. The eCoin device delivers electrical stimulation pulses to the median nerve from a small coin sized device placed under the skin of the distal anterior forearm. The implant delivers a weekly 30 minute treatment based on previous studies showing a long lasting and cumulative effect. The safety and efficacy of eCoin therapy has previously been demonstrated in a multinational, randomized, double-blind, sham-controlled study in New Zealand, Taiwan and Canada.
This trial is a multi-center, prospective, double-blind, 1:1 randomized sham-controlled study of the safety and effectiveness of eCoin median nerve neuromodulation in subjects with drug-treatment resistant hypertension. The eCoin neuromodulation device will be implanted subcutaneously in the right and left forearms of patients with uncontrolled hypertension despite treatment with 3 or more antihypertensive agents. After a 4 week implant healing period, subjects will be 1:1 randomized into either a treatment or control group. One half of the subjects have their devices activated (treatment) and the other half undergo a sham activation (control) to maintain participant blinding to their treatment allocation. During the six months post-randomization, the eCoin is ON in the treatment group and OFF in the control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment (ON) | Active comparator | Device: eCoin System |
| Control (OFF) | Sham comparator | Device: eCoin System |
Who may qualify
- Ages
- 30 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Individual is ≥30 and <75 years of age at the time of randomization.
- Individual is receiving a stable medication regimen including maximally tolerated doses of 3 or more anti-hypertensive medications of different classes, of which one must be a diuretic (with no changes for a minimum of 4 weeks prior to screening) that is expected to be maintained without changes for at least 6 months post randomization.
- Individual has an office systolic BP ≥140 mmHg and ≤180 mmHg and diastolic BP ≥80 mmHg and ≤110 mmHg measured at an initial screening visit and a confirmatory baseline visit.
- Individual has a 24 hour ambulatory systolic BP of ≥135 mmHg and ≤175 mmHg at baseline.
Key exclusion criteria (22 listed)
- Individual in whom medications are expected to change in the next 9 months (6 months post randomization).
- Individual does not agree to have all study procedures performed, and is not competent and willing to provide written, informed consent to participate in this clinical study.
- Individual has type 1 diabetes mellitus or type 2 diabetes mellitus with an A1C ≥ 9%.
- Individual has experienced, within one year of the screening visit, a myocardial infarction, hospitalized unstable angina pectoris, hospitalized heart failure, TIA or a cerebrovascular accident.
- Individual has a scheduled or planned surgery, cardiovascular intervention, or dialysis in the next six months.
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 |
|---|---|---|
| eCoin SystemMedian nerve neurostimulator. | Device | Control (OFF), Treatment (ON) |
Primary outcome
Difference in Change in 24-hr SBP Between Groups at 6 Months
Time frame: From baseline to 6 months post-randomization.
The difference in 24-hour ambulatory systolic blood pressure change from baseline to 6 months post-randomization between the eCoin neuromodulation ON (Treatment) and eCoin neuromodulation OFF (Control) groups.
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 23 Feb 2017.
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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 eCoin System in people with Resistant Hypertension, run by Valencia Technologies Corporation.
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 4 inclusion and 22 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 23 Feb 2017. 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. Some participants in this study may receive a placebo. 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?
Difference in Change in 24-hr SBP Between Groups at 6 Months (time frame: From baseline to 6 months post-randomization.). 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 23 Feb 2017.