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| ID | Type | Description | Link |
|---|---|---|---|
| 0449-13 | Other Identifier | The Department of Clinical Trials - Israel, Hadassah Helsinki Committee |
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| Name | Class |
|---|---|
| Hadassah Medical Organization | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treated Group | Experimental | This group will receive actual shockwave treatment |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omnispec model Vascuspec | Device | Energy Density: 0.09 - 0.1 mJ/mm2 Extracorporeal Shockwave Therapy |
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| Measure | Description | Time Frame |
|---|---|---|
| Ambulatory Blood Pressure Monitoring (ABPM) | Change in 24 hour ambulatory blood pressure (ABPM) from baseline to six months post last treatment (± 2 weeks) | 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) | 3 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Office Blood Pressure | Change in office blood pressure from baseline to three months and six months post last treatment (± 2 weeks). | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ayelet Shauer, MD | Contact | +972-2-6776564 | aye.shauer@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ayelet Shauer, MD | Hadassah Medical Organization | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hadassah Medical Organization | Jerusalem | 91120 | Israel |
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| ID | Term |
|---|---|
| C563514 | Hypertension Resistant to Conventional Therapy |
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| 3 Months |
| Ultrasound | Change in ultrasound-measured renal resistive index (RRI) | 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 | 6 Months |
| Adverse Events | 6 Months |
| Office Blood Pressure | Change in office blood pressure from baseline to three months and six months post last treatment (± 2 weeks). | 3 Months |