Hypertension, Resistant to Conventional TherapyPhase 1RHTNCT02042066
Safety and Efficacy Study of Extracorporeal Shockwave Therapy in the Treatment of Patients With Resistant Hypertension
A Phase 1 study testing Omnispec model Vascuspec in people with Hypertension, Resistant to Conventional Therapy, run by Medispec at 1 site in Israel.
Trial summary
Low intensity shockwaves have been proven in animal and human studies to increase tissue perfusion, promote angiogenesis and tissue regeneration and improve neural function. The hypothesis of this study is that shockwave therapy could improve the symptoms of patients with resistant hypertension. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertension, Resistant to Conventional Therapy
- What is being tested?
- Omnispec model Vascuspec
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2015to Jan 2016
- Phase
- Phase 1
- 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
- Subjects who have provided written informed consent.
- Age ≥18 and ≤80 years old.
- Office systolic blood pressure that remains ≥160 mmHg (≥150 mmHg for patient with type 2 diabetes) despite the stable use of ≥3 antihypertensive medications concurrently at maximally tolerated doses, of which one is a diuretic (unless there is a tolerance or a contraindication for a diuretics).
- Able and willing to comply with the required follow-up schedule.
Who cannot join
- Subjects who have participated in a clinical study involving another investigational drug or device within 4 weeks prior to Screening.
- Have hypertension secondary to an identifiable and treatable cause or take medication that can raise the BP.
- Prior renal artery intervention (balloon angioplasty or stenting).
- Pregnancy.
- Uncompensated heart failure.
- Chronic Liver Disease.
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- Patients with skin wound / infection at the treatment area.
- Subjects who take oral anti-coagulants.
- Local tumor of treatment area.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hadassah Medical Organization
Jerusalem, 91120
Ayelet Shauer, MD, +972-2-6776564, aye.shauer@gmail.com
Ayelet Shauer, MD
About this study
Official title: Efficacy and Safety of Low Intensity- Extracorporeal Shockwave Therapy in Drug Resistant Hypertension
Low intensity shockwaves have been proven in animal and human studies to increase tissue perfusion, promote angiogenesis and tissue regeneration and improve neural function.
The hypothesis of this study is that shockwave therapy could improve the symptoms of patients with resistant hypertension.
- Being tested
- Omnispec model Vascuspec
- Keywords
- Resistant Hypertension, RH, RHT, Blood Pressure, Kidney, Shockwave
- Medical subject headings
- Hypertension Resistant to Conventional Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omnispec model VascuspecDevice
Also called Vascuspec
Energy Density: 0.09 - 0.1 mJ/mm2 Extracorporeal Shockwave Therapy
| Study group | Role | What they receive |
|---|---|---|
| Treated Group | Experimental | This group will receive actual shockwave treatment Receives: Device: Omnispec model Vascuspec |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ambulatory Blood Pressure Monitoring (ABPM)
Change in 24 hour ambulatory blood pressure (ABPM) from baseline to six months post last treatment (± 2 weeks)
Measured: 6 Months
Ambulatory Blood Pressure Monitoring (ABPM)
Change in 24 hour ambulatory blood pressure (ABPM) from baseline to three months post last treatment (± 2 weeks)
Measured: 3 Months
Secondary outcomes (6)
Office Blood Pressure
Change in office blood pressure from baseline to three months and six months post last treatment (± 2 weeks).
Measured: 6 Months
Serum Urea and Creatinine
Change in serum urea and creatinine from baseline to 3 months and 6 months (± 2 weeks) post last treatment
Measured: 3 Months
Ultrasound
Change in ultrasound-measured renal resistive index (RRI)
Measured: 3 Months
Serum Urea and Creatinine
Change in serum urea and creatinine from baseline to 3 months and 6 months (± 2 weeks) post last treatment
Measured: 6 Months
Adverse Events
Measured: 6 Months
Office Blood Pressure
Change in office blood pressure from baseline to three months and six months post last treatment (± 2 weeks).
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2014 (estimated)
- Study startJan 2015
- Primary completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension, Resistant to Conventional TherapyStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medispec
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hadassah Medical Organization
- Responsible party
- Sponsor
- Investigators
- Ayelet Shauer, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02042066
- Sponsor's protocol ID
- RHT-01
- Other IDs
- 0449-13
- Acronym
- RHT
- Status last verified
- Jan 2014
- First submitted
- 19 Jan 2014
- Last updated
- 22 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Low Intensity- Extracorporeal Shockwave Therapy in Drug Resistant Hypertension
- ClinicalTrials.gov ID
- NCT02042066
- Acronym / sponsor ID
- RHT / RHT-01
- Keywords
- Resistant Hypertension, RH, RHT, Blood Pressure, Kidney, Shockwave
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- MedispecIndustry (pharma, biotech, devices)
- Collaborators
- Hadassah Medical Organization
- Study start
- Jan 2015
- Primary completion
- Jan 2016 (estimated)
- First posted
- 22 Jan 2014 (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.
Low intensity shockwaves have been proven in animal and human studies to increase tissue perfusion, promote angiogenesis and tissue regeneration and improve neural function.
The hypothesis of this study is that shockwave therapy could improve the symptoms of patients with resistant hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treated Group | Experimental | Device: Omnispec model VascuspecThis group will receive actual shockwave treatment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects who have provided written informed consent.
- Age ≥18 and ≤80 years old.
- Office systolic blood pressure that remains ≥160 mmHg (≥150 mmHg for patient with type 2 diabetes) despite the stable use of ≥3 antihypertensive medications concurrently at maximally tolerated doses, of which one is a diuretic (unless there is a tolerance or a contraindication for a diuretics).
- Able and willing to comply with the required follow-up schedule.
Key exclusion criteria (9 listed)
- Subjects who have participated in a clinical study involving another investigational drug or device within 4 weeks prior to Screening.
- Have hypertension secondary to an identifiable and treatable cause or take medication that can raise the BP.
- Prior renal artery intervention (balloon angioplasty or stenting).
- Pregnancy.
- Uncompensated heart failure.
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 |
|---|---|---|
| Omnispec model VascuspecAlso: VascuspecEnergy Density: 0.09 - 0.1 mJ/mm2 Extracorporeal Shockwave Therapy | Device | Treated Group |
Primary outcome
Ambulatory Blood Pressure Monitoring (ABPM)
Time frame: 6 Months
Change in 24 hour ambulatory blood pressure (ABPM) from baseline to six months post last treatment (± 2 weeks)
Ambulatory Blood Pressure Monitoring (ABPM)
Time frame: 3 Months
Change in 24 hour ambulatory blood pressure (ABPM) from baseline to three months post last treatment (± 2 weeks)
6 secondary outcomes
Office Blood Pressure
Time frame: 6 Months
Serum Urea and Creatinine
Time frame: 3 Months
Ultrasound
Time frame: 3 Months
Serum Urea and Creatinine
Time frame: 6 Months
Adverse Events
Time frame: 6 Months
Office Blood Pressure
Time frame: 3 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2014.
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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.
Ayelet Shauer, MD principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Omnispec model Vascuspec in people with Hypertension, Resistant to Conventional Therapy, run by Medispec at 1 site in Israel.
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 9 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 22 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Ayelet Shauer, MD (+972-2-6776564, aye.shauer@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ambulatory Blood Pressure Monitoring (ABPM) (time frame: 6 Months). The study lists 2 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 22 Jan 2014.