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

Primary Purpose

Hypertension, Resistant to Conventional Therapy

Status

Unknown status

Phase

Phase 1

Locations

Israel

Study Type

Interventional

Intervention

Omnispec model Vascuspec

About this trial

This is an interventional treatment trial for Hypertension, Resistant to Conventional Therapy focused on measuring Resistant Hypertension, RH, RHT, Blood Pressure, Kidney, Shockwave

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Hadassah Medical Organization

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treated Group

Arm Description

This group will receive actual shockwave treatment

Outcomes

Primary Outcome Measures

Ambulatory Blood Pressure Monitoring (ABPM)

Change in 24 hour ambulatory blood pressure (ABPM) from baseline to six months post last treatment (± 2 weeks)

Ambulatory Blood Pressure Monitoring (ABPM)

Change in 24 hour ambulatory blood pressure (ABPM) from baseline to three months post last treatment (± 2 weeks)

Secondary Outcome Measures

Office Blood Pressure

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

Serum Urea and Creatinine

Change in serum urea and creatinine from baseline to 3 months and 6 months (± 2 weeks) post last treatment

Ultrasound

Change in ultrasound-measured renal resistive index (RRI)

Serum Urea and Creatinine

Change in serum urea and creatinine from baseline to 3 months and 6 months (± 2 weeks) post last treatment

Adverse Events

Office Blood Pressure

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

Full Information

NCT ID

NCT02042066

First Posted

January 19, 2014

Last Updated

January 21, 2014

Sponsor

Medispec

Collaborators

Hadassah Medical Organization

1. Study Identification

Unique Protocol Identification Number

NCT02042066

Brief Title

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

Acronym

RHT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Unknown status

Study Start Date

January 2015 (undefined)

Primary Completion Date

January 2016 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medispec

Collaborators

Hadassah Medical Organization

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension, Resistant to Conventional Therapy

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treated Group

Arm Type

Experimental

Arm Description

This group will receive actual shockwave treatment

Intervention Type

Device

Intervention Name(s)

Omnispec model Vascuspec

Other Intervention Name(s)

Vascuspec

Intervention Description

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

Primary Outcome Measure Information:

Title

Ambulatory Blood Pressure Monitoring (ABPM)

Description

Change in 24 hour ambulatory blood pressure (ABPM) from baseline to six months post last treatment (± 2 weeks)

Time Frame

6 Months

Title

Ambulatory Blood Pressure Monitoring (ABPM)

Description

Change in 24 hour ambulatory blood pressure (ABPM) from baseline to three months post last treatment (± 2 weeks)

Time Frame

3 Months

Secondary Outcome Measure Information:

Title

Office Blood Pressure

Description

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

Time Frame

6 Months

Title

Serum Urea and Creatinine

Description

Change in serum urea and creatinine from baseline to 3 months and 6 months (± 2 weeks) post last treatment

Time Frame

3 Months

Title

Ultrasound

Description

Change in ultrasound-measured renal resistive index (RRI)

Time Frame

3 Months

Title

Serum Urea and Creatinine

Description

Change in serum urea and creatinine from baseline to 3 months and 6 months (± 2 weeks) post last treatment

Time Frame

6 Months

Title

Adverse Events

Time Frame

6 Months

Title

Office Blood Pressure

Description

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

Time Frame

3 Months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ayelet Shauer, MD

Phone

+972-2-6776564

aye.shauer@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ayelet Shauer, MD

Organizational Affiliation

Hadassah Medical Organization

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hadassah Medical Organization

City

Jerusalem

ZIP/Postal Code

91120

Country

Israel

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ayelet Shauer, MD

Phone

+972-2-6776564

aye.shauer@gmail.com

First Name & Middle Initial & Last Name & Degree

Ayelet Shauer, MD

First Name & Middle Initial & Last Name & Degree

David Libovitz, Professor

First Name & Middle Initial & Last Name & Degree

Ido Ben-Dov, MD

First Name & Middle Initial & Last Name & Degree

Shmuel Hen, MD

First Name & Middle Initial & Last Name & Degree

Amir Orlev, MD

12. IPD Sharing Statement

Learn more about this trial

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

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