Renal Denervation for High Blood Pressure

Recruiting at 56 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

337 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Symplicity Spyral™ multi-electrode renal denervation system for high blood pressure?

Research shows that the Symplicity Spyral™ system, a second-generation device for renal denervation (a procedure that reduces nerve activity in the kidneys), is effective in lowering blood pressure. Studies have demonstrated that this treatment is safe and can significantly reduce blood pressure in patients with resistant hypertension (high blood pressure that doesn't respond to medication). ^{1 2 3 4 5}

Is renal denervation safe for humans?

Renal denervation, including the Symplicity Spyral system, has been shown to be generally safe in humans, with several studies and trials supporting its safety for lowering high blood pressure. ^{1 2 3 5 6}

How is the Symplicity Spyral™ multi-electrode renal denervation system treatment different from other high blood pressure treatments?

The Symplicity Spyral™ system is unique because it uses a multi-electrode approach to perform renal denervation (a procedure that reduces nerve activity in the kidneys) to lower blood pressure, which is different from traditional medications. This system aims to simplify and shorten the procedure compared to earlier single-electrode systems, potentially offering a new option for patients with resistant hypertension who do not respond to standard drug treatments. ^{1 2 3 4 7}

What is the purpose of this trial?

The purpose of this study is to test the hypothesis that renal denervation decreases blood pressure and is safe when studied in the presence of up to three standard antihypertensive medications.

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

References

1. France pubmed.ncbi.nlm.nih.gov

Symplicity multi-electrode radiofrequency renal denervation system feasibility study. [2015]

2. France 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. [2013]

3. France 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. [2018]

4. Italy pubmed.ncbi.nlm.nih.gov

Percutaneous renal denervation and the second generation EnligHTN System. [2016]

5. England pubmed.ncbi.nlm.nih.gov

Radio frequency-based renal denervation: a story of simplicity? [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

New data, new studies, new hopes for renal denervation in patients with uncontrolled hypertension. [2022]

7. England 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. [2023]