Renal Pelvic Denervation Pilot Trial
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 21 Years to 80 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests the safety and effectiveness of the RPD system for people whose high blood pressure is not controlled by two medicines. The device enters through a natural body opening and uses radio-wave energy to destroy nerves near the urine-collecting area of both kidneys.
The RPD Pilot trial will evaluate the safety and effectiveness of Verve Medical's RPDTM renal denervation system for hypertensive patients with uncontrolled blood pressure despite use of two medications at a therapeutic dose. The novelty of the RPDTM system relates to its placement via natural orifice into the renal pelvis (bilaterally) for delivery of radiofrequency energy to ablate the nerves that pass through the outer wall of the renal pelvis, a technique referred to as renal pelvic denervation (RPD).
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Take two blood pressure medicines at treatment doses.
- One medicine must be an ACE inhibitor, ARB, or renin inhibitor. These block a system in the body that raises blood pressure.
- The second medicine must be a calcium channel blocker, which relaxes blood vessels, or a thiazide diuretic, or water pill.
- Have no changes to your blood pressure medicines for at least 30 days, and agree to no changes until after the study’s 2-month check.
- On a daytime blood pressure monitor, have an average top number of at least 135 but below 170, and a bottom number below 105.
- At the clinic, have a blood pressure top number of at least 140 but below 180.
Who can't join
- Are pregnant, breastfeeding, or planning pregnancy.
- Have certain kidney or urinary tract problems, such as kidney disease, low kidney function, dialysis, a kidney transplant, one kidney, kidney stones, infection, cancer, or abnormal urine drainage.
- Have certain heart or blood vessel problems, including an irregular heartbeat called atrial fibrillation, heart failure, or a heart attack or stroke in the past 6 months.
- Have type 1 diabetes, take certain diabetes drugs called SGLT2 inhibitors or GLP-1 agonists, or have high blood pressure caused by another illness.
- Take medicines that are not allowed, including clonidine, guanfacine, methyldopa, or drugs that can affect blood pressure, such as steroids and some pain or cold medicines.
- Have certain breathing problems, severe sleep apnea not well treated with CPAP, an untreated bleeding problem, opioid misuse, or chronic pain treated with opioids.
- Work night shifts, have an upper arm larger than 20 inches around, are in another high blood pressure trial, or had a device treatment for high blood pressure before.
- Have other conditions, planned procedures, trouble following medical care, or blood pressure measurement problems that could affect safety or study results. The study also excludes people expected to live less than 24 months and certain vulnerable groups, such as people in prison.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: 1. Currently taking 2 anti-hypertensive medications (NOTE: no changes to medications allowed until after 2-month primary endpoint). \- As recommended in ACC/AHA 2017 Guideline,2 subjects are to be taking one anti-hypertensive antagonizing the renin-angiotensin system, including ACE inhibitor, ARB or renin inhibitor. Second drug should either be a calcium channel blocker (amlodipine preferred) or a thiazide diuretic. 2. Stable antihypertensive medical regimen for at least 30 days. 3. Ambulatory mean daytime SBP ≥135 mmHg. 4. Ambulatory daytime SBP \<170 and DBP \<105 mmHg. 5. Office systolic SBP ≥140 mmHg and \<180. Exclusion Criteria: 1. History of non-compliance with medical care or medical treatments. 2. History of atrial fibrillation. 3. Pregnant (verified with a urine or blood pregnancy test), breast-feeding, or planning to become pregnant. Note that all premenopausal women will be screened for pregnancy (see section 4.7.4). 4. Office SBP ≥180 and DBP ≥110 mmHg. 5. Untreated urinary tract infection. 6. Renal collecting system is compromised, such that the subject cannot undergo routine cystoscopy and retrograde pyelogram, as exemplified by duplicated collecting system, i.e., two or more ipsilateral ureters. 7. Pre-existing hydronephrosis, presence of renal calculi or ectopic, pelvic or ptotic kidney(s). 8. Receiving dialysis treatment. 9. Renal transplant recipient. 10. Presence of only one kidney, or patients with dominant unilateral kidney function with one kidney split function less than 35% 11. Polycystic kidney disease. 12. Diabetes treated with SGLT2 inhibitor and/or GLP-1 agonist 13. Persistent albuminuria (urine with 30-300 mg albumin/g creatinine) 14. Focal sclerosing glomerulosclerosis. 15. On any of the following medications: clonidine, guanfacine, or methyldopa. 16. Known secondary causes of hypertension such as adrenal disease, renal artery stenosis, renovascular hypertension. 17. Evidence in medical history or at screening of hyperaldosteronism, defined as aldosterone/renin activity \> 30 or aldosterone level \>15 ng/dL 18. Glomerulonephritis or interstitial nephritis or eGFR \<45 ml/min/1.73m2. 19. Type I diabetes mellitus. 20. Stenotic valvular heart disease for which reduction of blood pressure would be hazardous. 21. One or more episodes of orthostatic hypotension within the prior 6 months defined in section 6.6.2 as reduction of systolic blood pressure of ≥20 mmHg or diastolic blood pressure of ≥10 mm Hg within 3 minutes of standing. 22. Myocardial infarction, unstable angina, or stroke in the prior 6 months. 23. History of symptomatic heart failure 24. Echocardiographic evidence of dilated, infiltrative or hypertrophic cardiomyopathy or intracardiac mass. 25. Surgically correctable valvular heart disease. 26. Peripheral arterial disease manifest clinically by claudication or non-healing ulcers. 27. Any medical condition (including psychiatric disease) that would interfere with conducting the study or would not be in the best interest of the subject. 28. Prior diagnosis of pulmonary hypertension, use of chronic oxygen therapy or need for mechanical ventilation 29. Presence of severe obstructive sleep apnea not treated adequately by CPAP at screening. 30. On medications that affect blood pressure through off target effects, e.g., NSAIDs, steroids etc. 31. Uncorrected bleeding diathesis 32. Any clinical condition that can affect blood pressure or require the use of medications that can affect blood pressure (e.g., NSAIDs, steroids, cold remedies). 33. Life expectancy \< 24 months for any reason (investigator determination). 34. Works night shifts. 35. Upper arm circumference \> 20". 36. Subjects currently enrolled in another hypertension trial. 37. Subjects who previously received device therapy for hypertension, including renal denervation. 38. Subjects with a history of recurrent renal stones including episodes within the prior 6 months (subjects with first diagnosis of asymptomatic renal stone(s) at baseline/screening can be treated and rescreened at least one week following successful therapy of nephrolithiasis). 39. History of narcotic / opiate drug abuse 40. History of chronic pain syndrome receiving ongoing therapy with narcotic and/or opiate therapy 41. Active uroepithelial cancer 42. Artificial urinary sphincter or penile prosthesis implanted. 43. Planned medical procedures that could potentially interfere with measurement of blood pressure or assessment of any safety/effectiveness endpoints within 12 months of randomization 44. Conditions that could potentially interfere with accuracy of blood pressure measurements 45. Vulnerable subject populations (e.g., incarcerated or cognitively challenged adults). 46. Pre-existing urological abnormalities such as hydronephrosis, ureteral vesicular reflux (congenital or acquired), neoplasia, etc. 47. Urinary tract anomalies or primary (FSGS) or secondary (e.g., Diabetic nephropathy) renal disease
Study sites (9)
AL
- University of Alabama at Birmingham · Birmingham, AL 35294Maria El Hachem · Study contact · mehachem@uabmc.eduEric Judd, MD · Principal investigatorMore trials in Birmingham
AZ
- Panoramic Health / Southwest Kidney Institute, PLC · Surprise, AZ 85374Ana Miller · Study contact · amiller@panoramichealth.comMinesh Rajpal, MD · Principal investigatorMore trials in Surprise
CA
- Folio Clinical Research/Manchester Medical Group · Los Angeles, CA 90045Kellie Konitzer · Study contact · kkonitzer@folioclinicalresearch.comPaymon Banafshe, DO · Principal investigatorMore trials in Los Angeles
IA
- University of Iowa Health Care · Iowa City, IA 52242Matt Dickerson · Study contact · matthew-dickerson@uiowa.eduWaleed Hassan, MD · Principal investigatorMore trials in Iowa City
IL
- SIU School of Medicine · Springfield, IL 62702Katy Martz · Study contact · kmartz35@siumed.eduJohn Flack, MD · Principal investigatorMore trials in Springfield
MN
- University of Minnesota · Minneapolis, MN 55455Kathryn Vera · Study contact · giero002@umn.eduJohn Osborn · Principal investigatorSabine Karam · Sub-investigatorMore trials in Minneapolis
- Mayo Clinic · Rochester, MN 55905More trials in Rochester
NV
- DaVita Clinical Research · Las Vegas, NV 89107Tetiana Kolomoiets · Study contact · tetiana.kolomoiets@davita.comMark Vishnepolsky, MD · Principal investigatorMore trials in Las Vegas
TX
- Azura Vascular Care · San Antonio, TX 78207Susan Marshall · Study contact · smarshall@rapadocs.comRashid Sharaf, MD · Principal investigatorMore trials in San Antonio