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

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

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.

Study Overview

• Status: Unknown
• Conditions: Hypertension, Resistant to Conventional Therapy
• Intervention / Treatment: Device: Omnispec model Vascuspec

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Ayelet Shauer, MD; Phone Number: +972-2-6776564; Email: aye.shauer@gmail.com

Study Locations

• Israel
  • Jerusalem, Israel, 91120
    • Hadassah Medical Organization
    • Principal Investigator: Ayelet Shauer, MD
    • Contact: Ayelet Shauer, MD; Phone Number: +972-2-6776564; Email: aye.shauer@gmail.com
    • Sub-Investigator: David Libovitz, Professor
    • Sub-Investigator: Ido Ben-Dov, MD
    • Sub-Investigator: Shmuel Hen, MD
    • Sub-Investigator: Amir Orlev, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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
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).	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
Office Blood Pressure	Change in office blood pressure from baseline to three months and six months post last treatment (± 2 weeks).	3 Months

Collaborators and Investigators

• Sponsor: Medispec
• Collaborators: Hadassah Medical Organization
• Investigators: Principal Investigator: Ayelet Shauer, MD, Hadassah Medical Organization

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Anticipated): January 1, 2016

Study Registration Dates

• First Submitted: January 19, 2014
• First Submitted That Met QC Criteria: January 21, 2014
• First Posted (Estimate): January 22, 2014

Study Record Updates

• Last Update Posted (Estimate): January 22, 2014
• Last Update Submitted That Met QC Criteria: January 21, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: Blood Pressure; Resistant Hypertension; Kidney; Shockwave; RH; RHT
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: RHT-01; 0449-13 (Other Identifier: The Department of Clinical Trials - Israel, Hadassah Helsinki Committee)