Uncontrolled HypertensionNCT07005050
Renal Pelvic Denervation Pilot Trial
A study testing RPD and Active hypertension medical therapy in people with Uncontrolled Hypertension, run by Verve Medical, Inc at 9 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Uncontrolled Hypertension
- What is being tested?
- RPD and Active hypertension medical therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 9 sitesUnited States
- Study dates
- 30 Jan 2026to 2 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- Peripheral arterial disease manifest clinically by claudication or non-healing ulcers.
- Any medical condition (including psychiatric disease) that would interfere with conducting the study or would not be in the best interest of the subject.
- Prior diagnosis of pulmonary hypertension, use of chronic oxygen therapy or need for mechanical ventilation
- Presence of severe obstructive sleep apnea not treated adequately by CPAP at screening.
- On medications that affect blood pressure through off target effects, e.g., NSAIDs, steroids etc.
- Uncorrected bleeding diathesis
- 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).
- Life expectancy < 24 months for any reason (investigator determination).
- Works night shifts.
- Upper arm circumference > 20".
- Subjects currently enrolled in another hypertension trial.
- Subjects who previously received device therapy for hypertension, including renal denervation.
- 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).
- History of narcotic / opiate drug abuse
- History of chronic pain syndrome receiving ongoing therapy with narcotic and/or opiate therapy
- Active uroepithelial cancer
- Artificial urinary sphincter or penile prosthesis implanted.
- Planned medical procedures that could potentially interfere with measurement of blood pressure or assessment of any safety/effectiveness endpoints within 12 months of randomization
- Conditions that could potentially interfere with accuracy of blood pressure measurements
- Vulnerable subject populations (e.g., incarcerated or cognitively challenged adults).
- Pre-existing urological abnormalities such as hydronephrosis, ureteral vesicular reflux (congenital or acquired), neoplasia, etc.
- Urinary tract anomalies or primary (FSGS) or secondary (e.g., Diabetic nephropathy) renal disease
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites, 8 recruiting
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Maria El Hachem, mehachem@uabmc.edu
Eric Judd, MD
- Recruiting
University of Iowa Health Care
Iowa City, Iowa, 52242
Matt Dickerson, matthew-dickerson@uiowa.edu
Waleed Hassan, MD
- Recruiting
DaVita Clinical Research
Las Vegas, Nevada, 89107
Tetiana Kolomoiets, tetiana.kolomoiets@davita.com
Mark Vishnepolsky, MD
- Recruiting
Folio Clinical Research/Manchester Medical Group
Los Angeles, California, 90045
Kellie Konitzer, kkonitzer@folioclinicalresearch.com
Paymon Banafshe, DO
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Kathryn Vera, giero002@umn.edu
John Osborn
- Withdrawn
Mayo Clinic
Rochester, Minnesota, 55905
- Recruiting
Azura Vascular Care
San Antonio, Texas, 78207
Susan Marshall, smarshall@rapadocs.com
Rashid Sharaf, MD
- Recruiting
SIU School of Medicine
Springfield, Illinois, 62702
Katy Martz, kmartz35@siumed.edu
John Flack, MD
- Recruiting
Panoramic Health / Southwest Kidney Institute, PLC
Surprise, Arizona, 85374
Ana Miller, amiller@panoramichealth.com
Minesh Rajpal, MD
About this study
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).
Read the detailed description
Hypertensive patients frequently fail to have blood pressure optimally controlled, even with use of multiple medicines. The risk of chronically uncontrolled hypertension are substantial. Several clinical trials demonstrate the potential utility of renal denervation to improve blood pressure control as an adjunct to medications, yet the results of the technology and associated procedures have proven inconsistent. The RICH 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).
Safety and effectiveness assessments will include measurement of ambulatory and automated office blood pressure, renal function, procedural complications and all adverse events. These randomized, double-blind, sham-controlled assessments will be conducted 2-, 6- and 12-months following the index procedure. Following completion of the 12-month assessments, sham treated subjects may receive open-label therapy if they meet the original inclusion/exclusion criteria, with all subjects followed for a total of 2 years.
Up until the Month 6 assessment is complete, anti-hypertensive medical therapy is not to be altered unless required by significant worsening of a hypertensive related disease or due to a hypertensive emergency. Following completion of the Month 6 assessments, blinded investigators will be permitted and encouraged to intensify anti-hypertensive medication(s) if clinically indicated, as described further in the protocol. Between years 1 and 2, investigators will continue to be encouraged to intensify anti-hypertensive therapy for subjects not at goal.
- Conditions
- Uncontrolled Hypertension
- Being tested
- RPD, Active hypertension medical therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RPDDevice
Renal Pelvic Denervation
Active hypertension medical therapyDrug
Prespecified two medication regimen for control of hypertension
| Study group | Role | What they receive |
|---|---|---|
| RPD arm | Experimental | The Verve RPD™ system is used to perform renal pelvic denervation via the urinary collecting system for the treatment of hypertension. The system does so through the delivery of RF energy to the walls of the renal pelvis - delivered via natural orifice through the urinary tract. During the course of the study, patients will be on active medical therapy for their hypertension. Receives: Device: RPD; Drug: Active hypertension medical therapy |
| Sham arm | Sham comparator | Sham procedure will include all steps employed in the renal pelvis denervation with exception of activation of the RPD™ Device. Sham procedure includes advancing guidewire, cystoscope and sheath to position within the renal pelvis, then deploying the RPD™ Device into the renal pelvis (within each kidney), keeping the device in place for 2 minutes (within each kidney) to simulate activation, and then withdrawing the device and sheath. During the course of the study, sham patients will be on active medical therapy for their hypertension. Receives: Drug: Active hypertension medical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary effectiveness
effects of the device/procedure on 24-hour blood pressure control in addition to use of 2 antihypertensive medications
Measured: 2 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start30 Jan 2026
- Primary completion30 Oct 2026 (estimated)
- Study completion2 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uncontrolled HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The study is multi-center, randomized, double-blind and sham-controlled, with sham treated subjects undergoing a procedure that includes use of cystoscopic placement of a guidewire and sheath into one kidney and then the other, to mirror how subjects are treated with RPD.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Verve Medical, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- RQM+
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07005050
- Sponsor's protocol ID
- CP0005
- Status last verified
- Jan 2026
- First submitted
- 26 May 2025
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Pelvic Denervation Pilot Trial
- ClinicalTrials.gov ID
- NCT07005050
- Acronym / sponsor ID
- CP0005
- Conditions
- Uncontrolled Hypertension
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Verve Medical, IncIndustry (pharma, biotech, devices)
- Collaborators
- RQM+
- Study start
- 30 Jan 2026 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 2 Mar 2029 (estimated)
- First posted
- 4 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Hypertensive patients frequently fail to have blood pressure optimally controlled, even with use of multiple medicines. The risk of chronically uncontrolled hypertension are substantial. Several clinical trials demonstrate the potential utility of renal denervation to improve blood pressure control as an adjunct to medications, yet the results of the technology and associated procedures have proven inconsistent. The RICH 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).
Safety and effectiveness assessments will include measurement of ambulatory and automated office blood pressure, renal function, procedural complications and all adverse events. These randomized, double-blind, sham-controlled assessments will be conducted 2-, 6- and 12-months following the index procedure. Following completion of the 12-month assessments, sham treated subjects may receive open-label therapy if they meet the original inclusion/exclusion criteria, with all subjects followed for a total of 2 years.
Up until the Month 6 assessment is complete, anti-hypertensive medical therapy is not to be altered unless required by significant worsening of a hypertensive related disease or due to a hypertensive emergency. Following completion of the Month 6 assessments, blinded investigators will be permitted and encouraged to intensify anti-hypertensive medication(s) if clinically indicated, as described further in the protocol. Between years 1 and 2, investigators will continue to be encouraged to intensify anti-hypertensive therapy for subjects not at goal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study is multi-center, randomized, double-blind and sham-controlled, with sham treated subjects undergoing a procedure that includes use of cystoscopic placement of a guidewire and sheath into one kidney and then the other, to mirror how subjects are treated with RPD.
| Arm | Type | Receives |
|---|---|---|
| RPD arm | Experimental | Device: RPD, Drug: Active hypertension medical therapyThe Verve RPD™ system is used to perform renal pelvic denervation via the urinary collecting system for the treatment of hypertension. The system does so through the delivery of RF energy to the walls of the renal pelvis - delivered via natural orifice through the urinary tract. During the course of the study, patients will be on active medical therapy for their hypertension. |
| Sham arm | Sham comparator | Drug: Active hypertension medical therapySham procedure will include all steps employed in the renal pelvis denervation with exception of activation of the RPD™ Device. Sham procedure includes advancing guidewire, cystoscope and sheath to position within the renal pelvis, then deploying the RPD™ Device into the renal pelvis (within each kidney), keeping the device in place for 2 minutes (within each kidney) to simulate activation, and then withdrawing the device and sheath. During the course of the study, sham patients will be on active medical therapy for their hypertension. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Currently taking 2 anti-hypertensive medications (NOTE: no changes to medications allowed until after 2-month primary endpoint).
- 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.
Key exclusion criteria (47 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RPDRenal Pelvic Denervation | Device | RPD arm |
| Active hypertension medical therapyPrespecified two medication regimen for control of hypertension | Drug | RPD arm, Sham arm |
Primary outcome
Primary effectiveness
Time frame: 2 months post treatment
effects of the device/procedure on 24-hour blood pressure control in addition to use of 2 antihypertensive medications
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RPD and Active hypertension medical therapy in people with Uncontrolled Hypertension, run by Verve Medical, Inc at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 47 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dan Merz (6126699209, dmerz@verve-medical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary effectiveness (time frame: 2 months post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.