euromodulation for Uncontrolled Hypertensio
- Conditions
- ncontrolled hypertensionUncontrolled hypertensionCardiovascular - Hypertension
- Registration Number
- ACTRN12613000360718
- Lead Sponsor
- Valencia Technologies, Corp.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 102
1.Individual has a systolic blood pressure measured at greater than or equal to 140mmHg in the most recent medical history and which is confirmed with in-office blood pressure measured at both an initial screening and baseline screening visit and also with a 24 hour Ambulatory blood pressure, despite adhering to a stable anti-hypertensive drug regimen for a minimum of two weeks prior to enrollment of three or more anti- hypertensive medications including a diuretic
OR
2.Individual has a systolic blood pressure measured at greater than or equal to 160mmHg in the most recent medical history and which is confirmed with in-office blood pressure measured at both an initial screening and baseline screening visit and also with a 24 hour Ambulatory blood pressure, despite adhering to a stable anti-hypertensive drug regimen for a minimum of two weeks prior to enrollment of two or more anti- hypertensive medications and has documented allergy to or intolerance of additional antihypertensive medications.
1.Individual in whom medications are expected to change during the next 12 months
2.Individual does not agree to have all study procedures performed, and is not competent and willing to provide written, informed consent to participate in this clinical study.
3.Individual has type 1 diabetes mellitus.
4.Individual has experienced a myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within six months of the screening visit.
5.Individual has a scheduled or planned surgery, cardiovascular intervention, or dialysis in the next six months.
6.Individual has hemodynamically significant valvular heart disease for which reduction of blood pressure would be considered hazardous.
7.Individual has any serious medical condition with a prognosis of <2 years.
8.Individual has significant anemia (hemoglobin <100g/L), thrombocytopenia (platelets <100x109/L) or a severe bleeding disorder eg. hemophilia.
9.Individual has secondary hypertension (other than associated with obstructive sleep apnea)
10.Individual is pregnant, nursing or planning to be pregnant.
11.Individual has known or suspected history of medication non-compliance
12.Individual has known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable to comply with study follow-up requirements.
13.Patient has undergone renal denervation.
14.Individual has severe renal dysfunction (CKD V, eGFR <15)
15.Individual has another implantable stimulation device including a cardiac pacemaker, ICD, spinal cord stimulator, brain stimulator, vagus nerve stimulator, peripheral nerve stimulator, or cochlear implant.
16.Patient is scheduled to have an MRI.
17.Individual is currently enrolled in another investigational drug or device trial that has not reached its primary endpoint.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint is change in Office Systolic Blood Pressure (SBP) using an automatic sphygmomanometer and following the American Heart Association guidelines.[From baseline to six months post implant and activation in total patient cohort.]
- Secondary Outcome Measures
Name Time Method Difference in office systolic blood pressure in those in whom the SNS is implanted and activated compared with those in whom it is implanted and not activated using an automatic sphygmomanometer and following the American Heart Association Guidelines.[Difference in office systolic blood pressure at 6 months in those in whom the SNS is implanted and activated compared with those in whom it is implanted and not activated]