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โ† Trials
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Renal Pelvic Denervation Pilot Trial

RecruitingNAAges 21 Years - 80 YearsAllVerve Medical, Inc
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In plain words

What the trial is, and whether it could suit you

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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ135 mmHg. 4. Ambulatory daytime SBP \<170 and DBP \<105 mmHg. 5. Office systolic SBP โ‰ฅ140 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 โ‰ฅ180 and DBP โ‰ฅ110 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 โ‰ฅ20 mmHg or diastolic blood pressure of โ‰ฅ10 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
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What it tests

  • RPD
  • Active hypertension medical therapy
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Where

9 sites
University of Alabama at Birmingham
Birmingham, United States
Panoramic Health / Southwest Kidney Institute, PLC
Surprise, United States
Folio Clinical Research/Manchester Medical Group
Los Angeles, United States
SIU School of Medicine
Springfield, United States
University of Iowa Health Care
Iowa City, United States
University of Minnesota
Minneapolis, United States
Mayo Clinic
Rochester, United States
DaVita Clinical Research
Las Vegas, United States

โ€ฆand 1 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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