Renal Denervation for High Blood Pressure

No longer recruiting at 60 trial locations

Overseen By Barry Bertolet, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medtronic Vascular

Must be taking: Antihypertensives

Must not be taking: NSAIDs

Disqualifiers: Diabetes, Heart failure, Angina, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether renal denervation can safely lower high blood pressure in individuals taking up to three blood pressure medications. The treatment uses the Symplicity Spyral™ multi-electrode renal denervation system to target nerves near the kidneys that influence blood pressure. Participants may be randomly assigned to receive either the actual treatment or a sham procedure, which mimics the real one without any therapeutic effect. This trial suits individuals with consistently high blood pressure despite medication use. As an unphased trial, it offers an opportunity to contribute to innovative research that could lead to new treatment options for high blood pressure.

Do I need to stop my current medications for the trial?

No, you do not need to stop your current medications. The trial is designed to study the procedure while you are taking up to three standard blood pressure medications.

What prior data suggests that the Symplicity Spyral™ multi-electrode renal denervation system is safe for reducing high blood pressure?

Research has shown that the Symplicity Spyral™ system is generally safe for people. This treatment lowers high blood pressure by targeting nerves around the kidneys. Importantly, patients who underwent this procedure did not report any major side effects.

In one study, participants experienced a drop in blood pressure both during activity and clinic visits over 24 months, with no major safety concerns. The treatment was well-tolerated, and no significant problems were reported.

Overall, evidence suggests that the Symplicity Spyral system is a safe option for managing high blood pressure when used alongside standard medications. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Symplicity Spyral™ system is unique because it targets high blood pressure through a procedure called renal denervation. Unlike standard treatments that typically involve medications like ACE inhibitors, beta-blockers, or diuretics, this system uses a minimally invasive technique to disrupt the nerves in the renal arteries, which can help lower blood pressure. Researchers are excited about this treatment because it offers a new way to manage high blood pressure for patients who may not respond well to conventional medications. By directly targeting the nerves that affect blood pressure regulation, it has the potential to provide a more sustained and effective reduction in blood pressure levels.

What evidence suggests that the Symplicity Spyral™ multi-electrode renal denervation system is effective for high blood pressure?

Research has shown that the Symplicity Spyral™ renal denervation system, which participants in this trial may receive, can help lower high blood pressure. This treatment affects the body's sympathetic nervous system, responsible for the "fight or flight" response. In one study, patients who received this treatment experienced a significantly greater drop in blood pressure compared to those who underwent a sham procedure, another arm of this trial. This indicates that the treatment effectively lowered blood pressure both during physical activity and in a clinical setting over a period of 24 months. Current guidelines suggest renal denervation for patients with high blood pressure not controlled by other medications. ^{1 2 4 5 6}

Who Is on the Research Team?

Raymond Townsend, MD

Principal Investigator

University of Pennsylvania

David Kandzari, MD

Principal Investigator

Piedmont Hospital

Kazuomi Kario, MD

Principal Investigator

Jichi Medical University

Michael Böhm, MD

Principal Investigator

Universitätskliniken des Saarlandes

Are You a Good Fit for This Trial?

This trial is for adults with high blood pressure (140-170 mmHg over 24 hours, or office SBP of 150-180 mmHg and DBP ≥ 90 mmHg) while on up to three blood pressure medications. It's not for those with severe kidney issues, recent heart problems, certain vascular conditions, poor renal anatomy, chronic pain treated with NSAIDs often, pregnant/nursing women, uncontrolled diabetes, orthostatic hypotension or night shift workers.

Inclusion Criteria

My blood pressure is high even though I am on 1-3 blood pressure medications.

Individual has 24-hour Ambulatory Blood Pressure Monitoring (ABPM) average SBP ≥ 140 mmHg and < 170 mmHg.

Exclusion Criteria

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

I regularly take painkillers for ongoing pain.

I have type 1 diabetes or my type 2 diabetes is not well-controlled.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Multiple visits for blood pressure measurements

Treatment

Participants undergo renal angiography and renal denervation or a sham procedure

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness, including blood pressure measurements and adverse events

6 months

Regular visits (in-person) and remote monitoring

What Are the Treatments Tested in This Trial?

Interventions

• Sham Procedure
• Symplicity Spyral™ multi-electrode renal denervation system

Trial Overview The SPYRAL HTN-ON MED Study is testing if the Symplicity Spyral™ renal denervation system can safely lower blood pressure compared to a sham procedure in patients already taking up to three antihypertensive drugs.

How Is the Trial Designed?

Group I: Renal Denervation Experimental Treatment 1 Intervention

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

Group II: Sham Procedure Placebo Group 1 Intervention

Renal angiography

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

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]

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]

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]

Citations

1. 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 ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40391448/

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

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

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) The Symplicity Spyral Renal Denervation System passed design verification (functional) bench testing including dimensional, strength, ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2772963X25000237

Long-Term, Patient-Level Analysis of Radiofrequency ... Renal denervation (RDN) lowers blood pressure (BP) in patients with uncontrolled hypertension. Current guidelines recommend RDN for patients with uncontrolled ...

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

NCT02439775 | SPYRAL HTN-ON MED Study of Renal ... Data obtained will be used to confirm the effect of renal denervation on elevated blood pressure in patients on 1, 2 or 3 antihypertensive medications. Official ...

6. 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 Proven to deliver significant, safe, and sustained blood pressure reductions2,3,9,10. Multiple randomized, sham-controlled clinical trials; Real-world ...