• Name of PI and Coordinator:
  Jordy Cohen, MD, Elkys Funez, Shira Blady
• Contact:
  Elkys Funez – elkys.funez@uphs.upenn.edu
• Purpose of Study/Patient Population: Antihypertensive class effects, blood pressure control, and renal and cardiac outcomes—The goal of this study is to evaluate the effect of obesity and body fat distribution on how blood pressure medication classes impact degree of blood pressure control.

• Name of PI and Sub I:
  Debbie Cohen, MD and Maria Bonanni, NP 
• Contact Coordinator:
  Jaldhi Patel, Jaldhi.Patel@pennmedicine.upenn.edu, 215-615-4886

Purpose of Study/Patient Population:

High blood pressure is also known as “hypertension.” The purpose of this clinical study is to see whether a medical device called the Paradise Renal Denervation System (also called The Paradise System) can lower high blood pressure in patients who are known to have hypertension. Renal denervation utilizing the Paradise system uses therapeutically heated ultrasound energy to disrupt nerve activity by either disabling or destroying the nerves that provide signals to the kidney and may lower blood pressure. 

Study Description

TRIO CAP is a non-randomized study designed to allow for continued access to ultrasound renal denervation therapy via the Paradise System, and to allow for the on-going collection of safety and effectiveness data in subjects with uncontrolled hypertension despite the prescription of three or more antihypertensive medications. Looking for 150 participants.

Duration: Enrollment in the study will continue until market approval or 150 subjects have been treated, whichever occurs first. All subjects undergoing ultrasound renal denervation will be followed for 5 years (60 months) following the study procedure.

Main Inclusion Criteria:

1. Age ≥18 and ≤75 years at time of consent of any gender
2. Documented history of hypertension with minimum 3 anti-hypertensive medications
3. Average seated office BP ≥140/90 mmHg at screening visit (V0) despite taking stable doses of three or more antihypertensive medications, including a diuretic, for at least 4 weeks prior to consent
4. Documented daytime ABP ≥135/85 mmHg following 4-week stabilization period on standardized antihypertensive medication regimen
5. Suitable renal anatomy compatible with the renal denervation procedure and documented by renal CTA or MRA of good quality performed within one year prior to consent (a CTA or MRA will be obtained in subjects without a recent (≤1 year) renal imaging)
6. Able and willing to comply with all study procedures

Main Exclusion Criteria:

1. Type I diabetes mellitus or uncontrolled Type II diabetes (defined as a plasma HbA1c ≥9.0%)
2. Secondary hypertension not including sleep apnea
3. Documented history of chronic active inflammatory bowel disorders such as Crohn’s disease or ulcerative colitis
4. eGFR of < 40 mL/min/1.73 m^2
5. Night shift workers
6. Any known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or for any reason in the opinion of the investigator, would be unlikely or unable to comply with study protocol requirements or whose participation may result in data analysis confounders
7. Pregnant, nursing or planning to become pregnant (documented negative pregnancy test required documented within a maximum of 7 days prior to procedure for all women of childbearing potential)

• Name of PI, Sub I and Coordinator:
  Debbie Cohen, MD, Yonghong Huan, MD, Matt Denker, MD, Robin Neubauer, RN
• Contact:
  Robin Neubauer, RN – robin.neubauer@uphs.upenn.edu, 215-615-0773
• Purpose of Study/Patient Population:
  The purpose of this study is to provide additional information about a medical device intended to help treat high blood pressure in patients who are currently not taking medications for high blood pressure.

• Name of PI, Sub I and Coordinator:
  Debbie Cohen, MD, Yonghong Huan, MD, Matt Denker, MD; Robin Neubauer, RN
• Contact:
  Robin Neubauer – robin.neubauer@uphs.upenn.edu, 215-615-0773
• Purpose of Study/Patient Population:
  The purpose of this study is to provide additional information about a medical device intended to help treat high blood pressure in patients whose blood pressure is not controlled, despite treatment with three blood pressure medications.