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

Hypertension, Resistant to Conventional Therapy Clinical Trial

— RHT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02042066
• Other study ID #: RHT-01
• Secondary ID: 0449-13
• Status: Not yet recruiting
• Phase: Phase 1
• First received: January 19, 2014
• Last updated: January 21, 2014
• Start date: January 2015

Study information

• Verified date: January 2014
• Source: Medispec
• Contact: Ayelet Shauer, MD
• Phone: +972-2-6776564
• Email: aye.shauer[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Vasospasm
• Hypertension
• Hypertension, Resistant to Conventional Therapy

Intervention

Device:
• Omnispec model Vascuspec
Energy Density: 0.09 - 0.1 mJ/mm2 Extracorporeal Shockwave Therapy

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (2)

Lead Sponsor	Collaborator
Medispec	Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Office Blood Pressure	Change in office blood pressure from baseline to three months and six months post last treatment (± 2 weeks).	6 Months	No
Secondary	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	No
Secondary	Ultrasound	Change in ultrasound-measured renal resistive index (RRI)	3 Months	No
Secondary	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	No
Secondary	Adverse Events		6 Months	Yes
Secondary	Office Blood Pressure	Change in office blood pressure from baseline to three months and six months post last treatment (± 2 weeks).	3 Months	No