Renal Denervation for High Blood Pressure

Not currently recruiting at 109 trial locations

Overseen By Mahesh Mulumudi, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medtronic Vascular

Disqualifiers: Renal anatomy, Oxygen support, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called Symplicity Spyral™ to assess its safety and effectiveness for individuals with high blood pressure not controlled by other means. The procedure, known as renal denervation, targets kidney nerves that can influence blood pressure. The trial also aims to gather long-term data from participants who have previously tried this treatment in earlier studies. To qualify for this trial, participants should have high blood pressure that remains at or above 140/90 mmHg, even when measured in a doctor's office. As an unphased trial, this study offers an opportunity to contribute to groundbreaking research that could lead to new treatment options for high blood pressure.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Symplicity Spyral system is safe for renal denervation?

Research has shown that the Symplicity Spyral™ system is generally safe for treating high blood pressure. Earlier studies found no major safety differences between individuals with chronic kidney disease and those without it, indicating the procedure is well-tolerated across different groups. Additionally, trials have demonstrated that the system effectively lowers blood pressure over time, with no unexpected safety issues reported. While all medical procedures carry some risks, evidence suggests that the Symplicity Spyral™ system is a safe option for many people with high blood pressure. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Renal Denervation, specifically using the Symplicity Spyral™ system, is unique because it offers a non-drug approach to managing high blood pressure. Unlike standard treatments that often involve daily medication like ACE inhibitors or beta-blockers, this method works by using a catheter to deliver targeted energy to overactive nerves in the renal arteries, potentially reducing blood pressure. Researchers are excited about this treatment because it targets the root cause of hypertension in a novel way, offering hope for patients who may not respond well to traditional medications.

What evidence suggests that the Symplicity Spyral system is effective for high blood pressure?

Research has shown that the Symplicity Spyral™ system, which participants in this trial will receive, can help lower high blood pressure by targeting the body's nervous system. In one study, patients who used this system experienced a significant drop in their blood pressure, even two years later. The system uses radio waves to calm overactive nerves in the kidneys that can cause high blood pressure. Results from the SPYRAL HTN-ON MED trial demonstrated significant blood pressure reductions in patients, offering hope for those struggling to control their hypertension. These findings suggest that the Symplicity Spyral™ system could be a promising option for managing high blood pressure. ^{2 4 5 6 7}

Who Is on the Research Team?

David Kandzari, MD

Principal Investigator

Piedmont Heart Institute

Felix Mahfoud, MD

Principal Investigator

Saarland University Hospital

Are You a Good Fit for This Trial?

This trial is for individuals with high blood pressure (systolic ≥140 mmHg) who may also have diabetes, kidney disease, or cardiovascular issues. It's not suitable for those with severe kidney impairment (eGFR <30), pregnant women, or anyone lacking the right renal artery anatomy.

Inclusion Criteria

I have high blood pressure with a reading of 140 mmHg or higher.

I have high blood pressure with a reading of 140 mmHg or higher.

Exclusion Criteria

My kidney arteries are not suitable for the procedure.

You have a medical condition that makes it hard to get an accurate blood pressure reading.

I need oxygen or a ventilator daily, not just for sleep apnea at night.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo renal angiography and renal denervation using the Symplicity Spyral multi-electrode renal denervation system

6 months

Regular visits for blood pressure monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Long-term follow-up

Long-term follow-up data collection from eligible subjects previously treated in related studies

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Symplicity Spyral™

Trial Overview The study tests the Symplicity Spyral system's safety and effectiveness in lowering blood pressure through renal denervation—a procedure that disrupts nerve signals to the kidneys.

How Is the Trial Designed?

Group I: Main Cohort: Renal Denervation Experimental Treatment 1 Intervention

Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)

Symplicity Spyral™ is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Symplicity Spyral for:

• Hypertension in patients where lifestyle modifications and antihypertensive medications do not adequately control blood pressure

Approved in European Union as Symplicity Spyral for:

• Hypertension in patients where lifestyle modifications and antihypertensive medications do not adequately control blood pressure

Approved in Canada as Symplicity Spyral for:

• Hypertension in patients where lifestyle modifications and antihypertensive medications do not adequately control blood pressure

Approved in Japan as Symplicity Spyral for:

• Investigational use only

Who Is Running the Clinical Trial?

Medtronic Vascular

Lead Sponsor

Trials

67

Recruited

57,500+

Geoff Martha

Medtronic Vascular

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Laura Mauri

Medtronic Vascular

Chief Medical Officer since 2022

MD from Harvard Medical School

Published Research Related to This Trial

In a study of 109 patients undergoing renal sympathetic denervation, those with combined hypertension experienced a greater reduction in blood pressure compared to those with isolated systolic hypertension after 3 months (9.3 mm Hg vs. 5.0 mm Hg).

However, patients with isolated systolic hypertension who had lower pulse wave velocity showed significant blood pressure reduction (12.1 mm Hg), suggesting that assessing arterial stiffness can help identify which isolated systolic hypertension patients may benefit from this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulse Wave Velocity Predicts Response to Renal Denervation in Isolated Systolic Hypertension. Fengler, K., Rommel, KP., Hoellriegel, R., et al.[2018]

In a study of 622 patients, a fixed-dose combination of 20 mg enalapril and 10 mg lercanidipine significantly reduced blood pressure by an average of -29.2/-14.2 mmHg, demonstrating its effectiveness in a real-world clinical setting.

The treatment was well tolerated, with a low incidence of adverse events (3.4%), and it also improved important health markers such as pulse pressure and reduced microalbuminuria from 14.6% to 6.5%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of a fixed-dose combination of lercanidipine and enalapril in daily practice. A comparison of office, self-measured and ambulatory blood pressure. Scholze, J., Bramlage, P., Trenkwalder, P., et al.[2015]

Lercanidipine, a lipophilic dihydropyridine, effectively reduces blood pressure uniformly over 24 hours, which is important for minimizing end-organ damage related to hypertension.

Clinical studies indicate that lercanidipine has a similar antihypertensive effect to other common medications and does not cause dangerous reflex tachycardia, with a safety profile comparable to non-lipophilic calcium antagonists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical advantages of lipophilic dihydropyridines. Mancia, G., Omboni, S., Zanchetti, A.[2012]

In a study of 28 untreated essential hypertensives, both felodipine and lercanidipine caused significant reductions in blood pressure and increases in heart rate and sympathetic activity during acute administration, indicating a strong initial sympathoexcitation.

After 8 weeks of treatment, while blood pressure reductions remained similar, the sympathetic responses (heart rate, norepinephrine, and muscle sympathetic nerve traffic) were significantly reduced, with lercanidipine returning to baseline levels, suggesting that the chronic effects of dihydropyridines on sympathetic activity differ between drugs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-versus long-term effects of different dihydropyridines on sympathetic and baroreflex function in hypertension. Grassi, G., Seravalle, G., Turri, C., et al.[2016]

The initial studies (Symplicity HTN-1 and 2) suggested that renal denervation (RDN) could significantly lower blood pressure in patients with resistant hypertension, but the later Symplicity HTN-3 study showed minimal effectiveness, with systolic blood pressure reductions dropping from 25-30 mmHg to less than 3 mmHg.

Despite the initial promise, RDN is not yet ready for widespread clinical use, and current recommendations emphasize improving medication adherence and careful adjustment of drug treatments to manage hypertension effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Renal denervation in treatment-resistant hypertension: a reappraisal. Persu, A., Jin, Y., Fadl Elmula, FE., et al.[2015]

In a 90-day study involving 133 elderly patients with isolated systolic hypertension, amlodipine was found to be more effective than nicardipine in reducing systolic blood pressure, particularly during nighttime monitoring.

Both medications were well-tolerated, but amlodipine's once-daily dosing provided a sustained antihypertensive effect, making it a suitable treatment option for elderly patients with this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized, comparative, double-blind study of amlodipine vs. nicardipine as a treatment of isolated systolic hypertension in the elderly. Mounier-Véhier, C., Jaboureck, O., Emeriau, JP., et al.[2019]

Catheter-based renal denervation (RDN) has shown significant and sustained reductions in blood pressure in clinical trials, making it a promising treatment for resistant hypertension.

The new multi-electrode Symplicity Spyral catheter has demonstrated clinical efficacy and safety in preliminary studies, potentially allowing for quicker procedures and expanding the use of RDN beyond just resistant hypertension to conditions like heart failure and chronic kidney disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Catheter-based Renal Sympathetic Denervation - Long-term Symplicity™ Renal Denervation Clinical Evidence, New Data and Future Perspectives. Mountfort, K., Mahfoud, F., Schmieder, R., et al.[2020]

The SYMPLICITY HTN-3 trial, involving 535 patients with treatment-resistant hypertension, demonstrated that renal artery denervation led to significant reductions in both office systolic blood pressure (-26.4 mm Hg) and 24-hour ambulatory systolic blood pressure (-15.6 mm Hg) compared to a sham control group at 36 months, indicating its efficacy in long-term blood pressure management.

Safety was confirmed as the rates of adverse events were similar between the renal artery denervation and sham control groups, with no late-emerging complications, supporting the procedure's safety profile over a 36-month follow-up period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term outcomes after catheter-based renal artery denervation for resistant hypertension: final follow-up of the randomised SYMPLICITY HTN-3 Trial. Bhatt, DL., Vaduganathan, M., Kandzari, DE., et al.[2023]

The OneShot Renal Denervation System successfully delivered radiofrequency energy to the renal arteries in 89% of patients, demonstrating feasibility in a simplified procedure for treating high blood pressure.

Patients experienced significant reductions in blood pressure over 12 months, with an average decrease of 30.6 mmHg, and no serious adverse events or renal artery stenosis were reported, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Renal denervation for resistant hypertension using an irrigated radiofrequency balloon: 12-month results from the Renal Hypertension Ablation System (RHAS) trial. Ormiston, JA., Watson, T., van Pelt, N., et al.[2013]

In a study comparing two renal artery denervation systems, the new-generation EnligHTN system produced deeper lesions (2.32 mm) than the Symplicity Spyral system (2.15 mm), suggesting potentially better efficacy for the EnligHTN system.

Both systems showed similar lesion widths, indicating that while the EnligHTN system may enhance treatment effectiveness through deeper lesions, the overall size of the lesions in terms of width remains comparable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of new-generation renal artery denervation systems: assessing lesion size and thermodynamics using a thermochromic liquid crystal phantom model. Al Raisi, SI., Barry, MT., Qian, P., et al.[2018]

Citations

1. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf22/P220026D.pdf

Symplicity Spyral™ - accessdata.fda.gov The Symplicity Spyral multi-electrode renal denervation catheter is designed to be used with the Symplicity G3 TM renal denervation radiofrequency (RF) ...

2. medtronic.com medtronic.com/en-us/healthcare-professionals/products/surgical-energy/ablation/radiofrequency-ablation/systems/symplicity-spyral-renal-denervation-system.html

Symplicity Spyral™ Renal Denervation System The Symplicity Spyral™ renal denervation (RDN) system is used during the Symplicity™ blood pressure procedure for the treatment of hypertension.

3. ahajournals.org ahajournals.org/doi/10.1161/CIRCINTERVENTIONS.125.015194?doi=10.1161/CIRCINTERVENTIONS.125.015194

24-Month Results From the SPYRAL HTN-ON MED Trial Catheter-based renal denervation (RDN) reduces high blood pressure (BP) by targeting the sympathetic nervous system. Randomized sham-controlled ...

4. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK595358/

Renal Denervation for People With Hypertension - NCBI - NIH Symplicity Spyral is a second-generation renal denervation (RDN) system designed to reduce blood pressure (BP) in people with uncontrolled hypertension.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT02439775

NCT02439775 | SPYRAL HTN-ON MED Study of Renal ... The purpose of this study is to test the hypothesis that renal denervation is safe and reduces systolic blood pressure (SBP) in patients with uncontrolled ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf22/P220026B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) The warnings and precautions can be found in the Symplicity Spyral multi-electrode renal denervation catheter and Symplicity G3 RF generator ...

7. ahajournals.org ahajournals.org/doi/10.1161/CIRCINTERVENTIONS.125.015194

24-Month Results From the SPYRAL HTN-ON MED Trial RDN produced significantly greater ambulatory and office systolic BP reductions at 24 months compared with sham control, despite higher antihypertensive ...