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

NCT02042066 | Unknown Phase 1

• 2 other identifiers: RHT-010449-13
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension, Resistant to Conventional Therapy

Keywords

Resistant Hypertension; RH; RHT; Blood Pressure; Kidney; Shockwave

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Office Blood Pressure

  6 Months

• Serum Urea and Creatinine

  3 Months

• Ultrasound

  3 Months

• Serum Urea and Creatinine

  6 Months

• Adverse Events

  6 Months

Study Arms (1)

Treated Group

EXPERIMENTAL

This group will receive actual shockwave treatment

Device: Omnispec model Vascuspec

Interventions

Omnispec model Vascuspec DEVICE

Energy Density: 0.09 - 0.1 mJ/mm2 Extracorporeal Shockwave Therapy

Also known as: Vascuspec

Treated Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medispec: lead
• Hadassah Medical Organization: collaborator

Study Sites (1)

Hadassah Medical Organization

Jerusalem, 91120, Israel

Location

MeSH Terms

Conditions

Hypertension Resistant to Conventional Therapy

Study Officials

• Ayelet Shauer, MD

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayelet Shauer, MD

CONTACT

+972-2-6776564; aye.shauer@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2014
• First Posted: January 22, 2014
• Study Start: January 1, 2015
• Primary Completion: January 1, 2016
• Last Updated: January 22, 2014

Record last verified: 2014-01

Locations

IL (1)