Renal Pelvic Denervation Pilot Trial

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Uncontrolled Hypertension

In brief

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).

Key facts

Study ID

NCT07005050

Run by

Verve Medical, Inc

People needed

60

Starts

2025-12-30

Expected to finish

2029-03-02

Last updated by the study team

2026-01-08

Who can join

Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Stable antihypertensive medical regimen for at least 30 days.
• Ambulatory mean daytime SBP ≥135 mmHg.
• Ambulatory daytime SBP <170 and DBP <105 mmHg.
• Office systolic SBP ≥140 mmHg and <180.

You may not qualify if…

• History of non-compliance with medical care or medical treatments.
• History of atrial fibrillation.
• 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).
• Office SBP ≥180 and DBP ≥110 mmHg.
• Untreated urinary tract infection.
• 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.
• Pre-existing hydronephrosis, presence of renal calculi or ectopic, pelvic or ptotic kidney(s).
• Receiving dialysis treatment.
• Renal transplant recipient.
• Presence of only one kidney, or patients with dominant unilateral kidney function with one kidney split function less than 35%
• Polycystic kidney disease.
• Diabetes treated with SGLT2 inhibitor and/or GLP-1 agonist
• Persistent albuminuria (urine with 30-300 mg albumin/g creatinine)
• Focal sclerosing glomerulosclerosis.
• On any of the following medications: clonidine, guanfacine, or methyldopa.
• Known secondary causes of hypertension such as adrenal disease, renal artery stenosis, renovascular hypertension.
• Evidence in medical history or at screening of hyperaldosteronism, defined as aldosterone/renin activity > 30 or aldosterone level >15 ng/dL
• Glomerulonephritis or interstitial nephritis or eGFR <45 ml/min/1.73m2.
• Type I diabetes mellitus.
• Stenotic valvular heart disease for which reduction of blood pressure would be hazardous.
• 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.
• Myocardial infarction, unstable angina, or stroke in the prior 6 months.
• History of symptomatic heart failure
• Echocardiographic evidence of dilated, infiltrative or hypertrophic cardiomyopathy or intracardiac mass.
• Surgically correctable valvular heart disease.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States (enrolling)
• Panoramic Health / Southwest Kidney Institute, PLC — Surprise, Arizona, United States (enrolling)
• University of Minnesota — Minneapolis, Minnesota, United States (enrolling)
• Mayo Clinic — Rochester, Minnesota, United States (enrolling)
• DaVita Clinical Research — Las Vegas, Nevada, United States (enrolling)

Full record on ClinicalTrials.gov

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