Safety and Efficacy Study of Extracorporeal Shockwave Therapy in the Treatment of Patients With Resistant Hypertension
Phase 1
- Conditions
- Hypertension, Resistant to Conventional Therapy
- Interventions
- Device: Omnispec model Vascuspec
- Registration Number
- NCT02042066
- Lead Sponsor
- Medispec
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 10
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treated Group Omnispec model Vascuspec This group will receive actual shockwave treatment
- Primary Outcome Measures
Name Time Method Ambulatory Blood Pressure Monitoring (ABPM) 3 Months Change in 24 hour ambulatory blood pressure (ABPM) from baseline to three months post last treatment (± 2 weeks)
- Secondary Outcome Measures
Name Time Method Serum Urea and Creatinine 6 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 Office Blood Pressure 3 Months Change in office blood pressure from baseline to three months and six months post last treatment (± 2 weeks).
Trial Locations
- Locations (1)
Hadassah Medical Organization
🇮🇱Jerusalem, Israel