Evaluation of the Integrated Radio Frequency Denervation System to Reduce Sympathetic Drive
- Conditions
- HypertensionType 2 DiabetesCardiovascular - HypertensionMetabolic and Endocrine - Diabetes
- Registration Number
- ACTRN12620000412932
- Lead Sponsor
- Metavention, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 45
1) Age greater than or equal to 22 and less than or equal to 70 years old
2) Type 2 Diabetes diagnosis meeting the following criteria:
a) On oral anti-diabetic (OAD) medication: Hb1A1c 58 mmol/mol – 97 mmol/mol (7.5% - 11%), AND on a consistent drug regimen of oral anti diabetic agents (i.e., metformin, SGLT-2 inhibitor) or injectables (GLP 1-Ra) for at least 90 days prior to screening
OR
b) Medication naïve subjects at screening (off any medications for diabetes for at least 90- days): HbA1c 53 mmol/mol – 86 mmol/mol (7% - 10%)
3) Diagnosis of Hypertension meeting one of the following screening criteria AND baseline criteria:
a)Subjects on antihypertension medication at screening:
Office Systolic BP greater than or equal to 130 mmHg and less tahn 180 mmHg based on an average of 3 automated office blood pressure (AOBP) readings, AND on a consistent regimen of 1 - 2 antihypertensive medications (monotherapy or combination pills) or up to 3 oral antihypertensive agents (ARBs, CCBs, ACE inhibitors, hydrochlorothiazide etc.) for at least 4 weeks prior to screening
OR
b)Medication naïve subjects at screening (off any medications for hypertension for at least 28- days prior to screening):
Office Systolic BP greater than or equal to 140 mmHg and less tahn 180 mmHg based on an average of 3 automated office blood pressure (AOBP) readings.
AND
c)Subjects at Baseline (not on medication):
Systolic daytime BP greated than or equal to 135 mmHg and less than 170 mmHg based on baseline ABPM
4) Waist circumference criteria greater than or equal to 102 cm (male) and greater than or equal to 88cm (female)
i) Asians: greater than or equal to 90 cm (male) and greater than or equal to 80 cm (female)
5) Willing and able to discontinue all anti-hypertensive medications through 90-day follow-up visit
6) Documented status of stable lifestyle modifications
7) Women of childbearing potential (WOCBP) must be using at least one acceptable method of contraception throughout the study
8)BMI >40 kg/m2
9)Diagnosis of type 1 diabetes
10)Use of insulin within 90 days of consent
11)Two or more self-reported or documented severe hypoglycaemia events (severe hypoglycaemia event defined as severe cognitive impairment requiring external assistance for recovery) in the 180 days prior to Screening or any hypoglycaemia event from the time of Screening until Index Procedure
12)One or more documented hyperglycaemia episodes requiring hospitalization in the 180-days prior to Index Procedure
13)Severe hyperglycaemia event (confirmed by 2 consecutive fasting plasma glucose levels >240mg/dL) from time of Screening until Index Procedure
14)Current use of >2 antihypertension medications (monotherapy or combination pills) or >3 oral antihypertensive agents (ARBs, CCBs, ACE inhibitors, hydrochlorothiazide etc.)
15)Prescribed to any standard antihypertensive of cardiovascular medication (e.g., beta blockers) for other chronic conditions (e.g., ischemic heart disease) such that discontinuation might pose serious risk to health
16)Severe hypertensive episode within 180 days prior to the Index Procedure (confirmed by 3 Office Systolic BP measurements of greater than or equal to 180 mmHg)
17)A history of bariatric surgery, baroreflex activation therapy, or liver transplant, or these procedures are planned in the 365 days following Index Procedure
18)Any surgical procedure within 30 days prior to Index Procedure
19)Previous renal denervation procedure
20)History of or current symptomatic gallstones (e.g., cholecystitis, bile duct dilatation) without a cholecystectomy being performed (Note: subjects who have had a cholecystectomy are not excluded)
21)Previous hepatobiliary surgery/intervention that in the opinion of the investigator could preclude the ability to perform denervation of the CHA
22)Currently taking the following medications within 90 days prior to screening and/or there is a need or anticipated need for these medications during the study:
a)Systemic Corticosteroids
b)Anticonvulsants
c)Centrally acting sympatholytics (other than for treatment of hypertension)
23)Use of anticoagulation therapy which cannot be discontinued from 7 days before to 14 days after the Index Procedure
24)Any other condition(s) that would compromise the safety of the subject or compromise study quality as judged by the Investigator
25)eGFR <45 mL/min/1.73 m2
26)History or diagnosis of proliferative retinopathy or advanced autonomic neuropathy (e.g., orthostatic hypotension attributable to autonomic neuropathy, a diagnosis of gastroparesis, or a clinical history strongly suggestive of delayed gastric emptying)
27)Myocardial infarction, unstable angina, stroke, or transient ischemic attack within the 180 days prior to Index Procedure, or has widespread atherosclerosis, with documented intravascular thrombosis or unstable plaques
28)Subject has any of the following conditions: severe cardiac valve stenosis, heart failure (New York Heart Association [NYHA] Class III or IV), chronic atrial fibrillation, and known primary pulmonary hypertension (>60 mmHg pulmonary artery or right ventricular systolic pressure).
29)Documented history or concurrent signs of significant thyroid disease NOTE: If a subject is on chronic thyroid drug treatment, and has a serum TSH test result in normal range at Baseline they may enter study
30)Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet co
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method