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

Medispec

Status and phase

Unknown

Phase 1

Conditions

Hypertension, Resistant to Conventional Therapy

Treatments

Device: Omnispec model Vascuspec

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02042066

RHT-01

0449-13 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

10 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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.