Hypertension, Resistant to Conventional Therapy
Conditions
Keywords
Resistant Hypertension, RH, RHT, Blood Pressure, Kidney, Shockwave
Brief 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.
Interventions
DEVICEOmnispec model Vascuspec
Energy Density: 0.09 - 0.1 mJ/mm2 Extracorporeal Shockwave Therapy
Sponsors
Hadassah Medical Organization
Medispec
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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. * Patients with skin wound / infection at the treatment area. * Subjects who take oral anti-coagulants. * Local tumor of treatment area.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ambulatory Blood Pressure Monitoring (ABPM) | 6 Months | Change in 24 hour ambulatory blood pressure (ABPM) from baseline to six months post last treatment (± 2 weeks) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Office Blood Pressure | 6 Months | Change in office blood pressure from baseline to three months and six months post last treatment (± 2 weeks). |
| Serum Urea and Creatinine | 3 Months | Change in serum urea and creatinine from baseline to 3 months and 6 months (± 2 weeks) post last treatment |
| Ultrasound | 3 Months | Change in ultrasound-measured renal resistive index (RRI) |
| Adverse Events | 6 Months | — |
Countries
Israel
Contacts
Primary ContactAyelet Shauer, MD
Outcome results
None listed