What is the mechanism of action of this treatment?

Common treatments for Chronic Kidney Disease (CKD) focus on managing hypertension, a critical factor in disease progression. ACE inhibitors and ARBs reduce the effects of angiotensin II, leading to blood vessel dilation, lower blood pressure, and decreased intraglomerular pressure, which helps protect kidney function. Renal denervation, a newer treatment, disrupts renal nerves to reduce sympathetic nerve activity and lower blood pressure. This is particularly important for CKD patients with resistant hypertension, as it offers an alternative method to control blood pressure and potentially slow the progression of the disease.

What side effects are associated with this type of intervention?

Common treatments for Chronic Kidney Disease (CKD) include antihypertensive medications such as ACE inhibitors, ARBs, and diuretics. ACE inhibitors and ARBs can cause side effects like hyperkalemia (high potassium levels), decreased glomerular filtration rate (GFR), and hypotension. Diuretics may lead to electrolyte imbalances, dehydration, and increased urination. Renal denervation, a procedure to reduce blood pressure by disrupting renal nerves, may have side effects such as pain at the catheter insertion site, potential kidney damage, and rare complications like renal artery injury.

What prior FDA approvals exist?

The FDA has approved several treatments for managing blood pressure in patients with Chronic Kidney Disease (CKD). These include angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs), which are commonly used to control hypertension and reduce proteinuria in CKD patients. Additionally, mineralocorticoid receptor antagonists like spironolactone and eplerenone are used as fourth-line agents for resistant hypertension. While these medications do not directly disrupt renal nerves like renal denervation, they play a crucial role in managing blood pressure and slowing CKD progression.

What other types of research exist?

Promising alternatives to renal denervation for CKD patients include: 1) Angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs), which are effective in reducing proteinuria and slowing CKD progression. 2) Non-dihydropyridine calcium channel blockers, which can be used as second-line therapy in patients with proteinuria. 3) Diuretics, particularly loop diuretics, for managing volume expansion and hypertension in CKD patients. These therapies should be tailored to individual patient needs and monitored for efficacy and safety.

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Device

Renal Denervation for High Blood Pressure

N/A

Recruiting

Led By David Kandzari, MD

Research Sponsored by Medtronic Vascular

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Individual is diagnosed with hypertension and has a baseline office systolic blood pressure ≥140 mmHg

Diagnosed with hypertension and has a baseline office systolic blood pressure ≥140 mmHg

Must not have

Lacks appropriate renal artery anatomy

Has undergone prior renal denervation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed here, renal denervation procedures can potentially cause nerve damage, bleeding, infection, or negative reactions related to catheter-based treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My kidney arteries are not suitable for the procedure.

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I have had a procedure to decrease nerve activity in my kidneys.

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

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I have experienced dizziness due to a sudden drop in blood pressure when standing up.

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I have high blood pressure in the lungs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The Primary endpoint of office Systolic Blood Pressure (SBP) change at 6 months.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Main Cohort: Renal DenervationExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Renal Denervation (Symplicity Spyral™)

2020

N/A

~130

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Chronic Kidney Disease (CKD) focus on managing hypertension, a critical factor in disease progression. ACE inhibitors and ARBs reduce the effects of angiotensin II, leading to blood vessel dilation, lower blood pressure, and decreased intraglomerular pressure, which helps protect kidney function. Renal denervation, a newer treatment, disrupts renal nerves to reduce sympathetic nerve activity and lower blood pressure. This is particularly important for CKD patients with resistant hypertension, as it offers an alternative method to control blood pressure and potentially slow the progression of the disease.

[A Chinese Nephrology and Dialysis Unit in the eyes of a western nephrologist].Rapidly deteriorating renal function with membranoproliferative glomerulonephritis Type 1 associated with hepatitis C treated successfully with steroids and antiviral therapy: a case report and review of literature.