Safety and Efficacy Study of Extracorporeal Shockwave Therapy in the Treatment of Patients With Resistant Hypertension

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy and Safety of Low Intensity- Extracorporeal Shockwave Therapy in Drug Resistant Hypertension

Conditions
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Hypertension, Resistant to Conventional Therapy

Intervention / Treatment
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* Device: Omnispec model Vascuspec


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treated Group<br>This group will receive actual shockwave treatment | Device: Omnispec model Vascuspec<br>* Energy Density: 0.09 - 0.1 mJ/mm2 Extracorporeal Shockwave Therapy<br>* Other names: Vascuspec;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Resistant Hypertension, RH, RHT, Blood Pressure, Kidney, Shockwave