New device could help patients with Hard-to-Control blood pressure
NCT ID NCT07081243
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study follows 500 people in China with resistant hypertension who have already received the Symplicity Spyral renal denervation system. The device uses radiofrequency energy to calm overactive kidney nerves that can raise blood pressure. Researchers will track blood pressure changes, medication use, and safety for up to 36 months to see if the treatment provides lasting benefits.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Symplicity Spyral Renal Denervation System (a device that uses radiofrequency energy to disrupt nerves in the kidney arteries to lower blood pressure)
- What this could lead to
- If successful, this could confirm that renal denervation provides lasting blood pressure reduction for people with resistant hypertension, offering an alternative to lifelong medication.
- What could go wrong
- This is an observational study, not a randomized trial, so results may be less definitive. The device is already approved, but long-term durability and safety in a real-world Chinese population are still being assessed.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 500 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Dec 2031
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients diagnosed with resistant hypertension or antihypertensive drug intolerance. Resistant hypertension, defined as having an office systolic blood pressure (SBP) ≥140 mmHg despite appropriate lifestyle measures and being treated with three or more antihypertensive medications (including a diuretic) for more than 3 months. Drug intolerance, defined as patients who cannot tolerate medication due to contraindications or adverse effects.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Aged 18 years or older. 2. Patients diagnosed with resistant hypertension or antihypertensive drug intolerance and treated with Symplicity Spyral Renal Denervation System. Resistant hypertension, defined as having an office systolic blood pressure (SBP) ≥140 mmHg despite appropriate lifestyle measures and being treated with three or more antihypertensive medications (including a diuretic) for more than 3 months; or drug intolerance, defined as patients who cannot tolerate medication due to contraindications or adverse effects. 3. The patient voluntarily undergoes renal denervation; the patient has been informed of the observational nature of the study; the patient voluntarily provides written informed consent ("Patient Informed Consent Form") and willingly participates in the study. Exclusion Criteria: 1. At least one main renal artery with a diameter less than 3 mm or greater than 8 mm. 2. Presence of fibromuscular dysplasia. 3. Renal artery stent placement within 3 months prior to the procedure. 4. Presence of Renal artery aneurysms. 5. Presence of more than 50% stenosis in any treatable vessel. 6. Pregnant. 7. Present of renal or adrenal tumors. 8. Iliac/femoral artery stenosis prevents catheter insertion.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Zhongshan Hospital Fudan University
RECRUITINGShanghai, Shanghai Municipality, 210000, China
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- New study seeks to identify who benefits from Last-Resort blood pressure drugs