Renal Denervation for High Blood Pressure

Recruiting at 100 trial locations

Overseen By Mahesh Mulumudi, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Medtronic Vascular

Disqualifiers: Renal anatomy, Oxygen support, Diabetes, others

No Placebo Group

Approved in 5 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is studying the safety and effectiveness of a device called the Symplicity Spyral system, which helps lower blood pressure by calming overactive nerves in the kidneys. It includes patients who have already received this treatment. The Symplicity Spyral system is part of a series of treatments, with earlier versions showing significant blood pressure reductions in patients with resistant hypertension.

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 data supports the effectiveness of the treatment Symplicity Spyral™ for high blood pressure?

The Symplicity HTN-1 and HTN-2 studies showed that renal denervation (RDN) can significantly lower blood pressure in patients with resistant hypertension. Preliminary data from studies using the Symplicity Spyral catheter suggest it is effective and safe, with reduced procedure times, although more data is needed to confirm these findings. ^{1 2 3 4 5}

Is renal denervation safe for treating high blood pressure?

The provided research articles do not contain specific safety data for renal denervation treatment for high blood pressure. ^{6 7 8 9 10}

How is the Symplicity Spyral treatment different from other treatments for high blood pressure?

The Symplicity Spyral treatment is unique because it uses a catheter-based approach to target the renal nerves, which can help lower blood pressure in patients with resistant hypertension. This method, known as renal denervation, offers a new way to manage high blood pressure by reducing nerve activity in the kidneys, and it has shown promising results in clinical trials. ^{1 2 3 4 5}

Research Team

David Kandzari, MD

Principal Investigator

Piedmont Heart Institute

Felix Mahfoud, MD

Principal Investigator

Saarland University Hospital

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Symplicity Spyral™ (Device)

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.

Participant Groups

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 Canada, Japan for the following indications:

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

Findings from Research

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]

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 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]

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 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 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]

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 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]

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]

References

1. 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]

2. England pubmed.ncbi.nlm.nih.gov

Renal denervation in treatment-resistant hypertension: a reappraisal. [2015]

3. England pubmed.ncbi.nlm.nih.gov

Catheter-based Renal Sympathetic Denervation - Long-term Symplicity™ Renal Denervation Clinical Evidence, New Data and Future Perspectives. [2020]

4. 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]

5. 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]

6. England pubmed.ncbi.nlm.nih.gov

Pulse Wave Velocity Predicts Response to Renal Denervation in Isolated Systolic Hypertension. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Short-versus long-term effects of different dihydropyridines on sympathetic and baroreflex function in hypertension. [2016]

8. Sweden pubmed.ncbi.nlm.nih.gov

Clinical advantages of lipophilic dihydropyridines. [2012]

9. England pubmed.ncbi.nlm.nih.gov

Randomized, comparative, double-blind study of amlodipine vs. nicardipine as a treatment of isolated systolic hypertension in the elderly. [2019]

10. England 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. [2015]