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New treatment option for Resistant Hypertension
Official title Early Feasibility Study of "HyperQureTM RDN System", Laparoscopic Renal Denervation Therapy, in Patients With Resistant Hypertension
ClinicalTrials.gov ID: NCT06526858
What this study is testing
- What it's testing
- HQ-HTN-G01 is a prospective, multicenter, single arm, open label, early feasibility study to evaluate initial safety and device design concept of "HyperQureTM RDN System", laparoscopic renal denervation therapy, in patients with resistant hypertension on three(3) or more antihypertensive medications
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 80
You may be able to join if
- people are eligible to participate if all of the following criteria are met:
- Aged ≥22 and ≤80 years old at time of enrollment (consent).
- Diagnosed with resistant hypertension.
- Office BP ≥140/90 mmHg at Screening Visit 1, and on at least 3 antihypertensive medications of different classes including a diuretic for at least 4...
- Daytime ABP ≥135/85 mmHg after a four (4)-week run-in period at Screening Visit 2.
You likely can't join if
- people are not eligible to participate if any of the following criteria are met:
- Has coverage diameter of renal artery less than 2 mm or greater than 11 mm.
- Has one or more of the following conditions:
- Unstable angina with stent implantation (percutaneous coronary intervention) within 3 months of enrolment.
- Myocardial infarction within 3 months of enrollment.
- Acute heart failure (New York Heart Association (NYHA) III-IV) within 3 months of enrollment
See the full eligibility criteria
Who can join
- people are eligible to participate if all of the following criteria are met:
- Aged ≥22 and ≤80 years old at time of enrollment (consent).
- Diagnosed with resistant hypertension.
- Office BP ≥140/90 mmHg at Screening Visit 1, and on at least 3 antihypertensive medications of different classes including a diuretic for at least 4 weeks prior to consent.
- Daytime ABP ≥135/85 mmHg after a four (4)-week run-in period at Screening Visit 2.
- Agrees to have all study procedures performed, and is competent and willing to provide written, informed consent to participate in this clinical study.
What rules you out
- people are not eligible to participate if any of the following criteria are met:
- Has coverage diameter of renal artery less than 2 mm or greater than 11 mm.
- Has one or more of the following conditions:
- Unstable angina with stent implantation (percutaneous coronary intervention) within 3 months of enrolment.
- Myocardial infarction within 3 months of enrollment.
- Acute heart failure (New York Heart Association (NYHA) III-IV) within 3 months of enrollment
- Cerebrovascular accident or transient ischemic attack within 3 months of enrollment.
- Atrial fibrillation patients undergoing treatment and not in sinus rhythm. Notes: Patients who have received medical treatment, catheter or surgical treatment for atrial fibrillation and are in sinus rhythm are not...
- Has one or more of the following confirmed anatomical findings in the kidney or renal artery that are not suitable for renal denervation (assessed by the renal CT angiography of Screening 2)
- A single functioning kidney.
- An atheroma, aneurysm or renal artery stent within 5 mm of the renal denervation site.
- Presence of stenosis of 30% or more on all of the blood vessels available for renal denervation therapy.
- When it is deemed impossible to perform denervation on both renal arteries according to the discretion of the investigator.
- Has one or more of the following medical history or a history of surgery/procedure that is not suitable for renal denervation therapy
- Renal denervation therapy.
- Polycystic kidney disease (PKD).
- Atrophic kidney.
- Kidney transplant.
- Dialysis due to end-stage renal disease.
- Any surgery performed on both kidneys. (except endoscopy type of surgery, i.e. endoscopic kidney stone removal)
- FMD (Fibromuscular dysplasia)
- Has comorbidities or surgical/procedural history that are not suitable for retroperitoneal approach
- Surgical history through retroperitoneal approach.
- Fibrosis in the retroperitoneal region.
- Inflammation in the retroperitoneal region.
- Severe obesity (body mass index (BMI) \> 40 kg/m2)
- Risk of increased intracranial pressure
- Has a history of any intervention for underlying renal artery pathology including stenting or balloon angioplasty.
- Individual has an eGFR of \<45 mL/min/1.73m2, using the 4 variable Modification of Diet in Renal Disease (MDRD) calculation (in mL/min) per 1.73 m2 = 175 x Serum Cr-1.154 x age-0.203 x 1.212 (if patient is black) x...
- Type I diabetes mellitus or uncontrolled Type II diabetes (defined as a plasma Hb1Ac ≥ 9.0%).
- Has had a reduction of SBP of ≥20 mm Hg or DBP of ≥10 mm Hg within 3 minutes of standing coupled with symptoms during the screening process (at Screening Visit 2).
- Requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea (e.g., CPAP, BiPAP).
- Has documented primary pulmonary hypertension.
- Has an untreated secondary cause of hypertension (either known or suspected) or is taking drugs that increase sympathetic tone and could contribute to hypertension.
- Has a scheduled or planned surgery that, in the opinion of the Investigator, may affect study endpoints.
- Works night shifts.
- Has severe cardiac valve stenosis for which, in the opinion of the Investigator, a significant reduction of blood pressure is contraindicated.
- Is pregnant, nursing or planning to become pregnant during the course of the study follow-up (Note: Female participants of childbearing potential must have a negative serum or urine human chorionic gonadotropin (hCG)...
- Has a known unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable, in the opinion of the Investigator, to comply with study...
- Has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
- Patients who are at high risk if taken off their anticoagulant and antiplatelet agents for a few days.
- Allergy, intolerance or contraindications to contrast medium.
- Prescribed any standard antihypertensive cardiovascular medication for other chronic conditions (e.g. ischemic heart disease) for less than 90 days before Screening visit 1 and whose discontinuation might pose serious...
- Has frequent intermittent or chronic pain that results in the treatment with non-steroidal anti-inflammatory drugs (NSAIDs) for two (2) or more days per week over the month prior to Screening Visit 2.
- Concurrent enrollment in any other investigational drug or device study(Participation in non-treatment Registries is acceptable).
The study team makes the final eligibility decision.
Where it's taking place
- Orange, California, United States
- Stanford, California, United States
- Gainesville, Florida, United States
- Detroit, Michigan, United States
- Rochester, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Orange, California, United States; Stanford, California, United States; Gainesville, Florida, United States; Detroit, Michigan, United States; Rochester, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.