Renal Artery Denervation for High Blood Pressure

(RADAR Trial)

Overseen By Debbie Reynolds, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Ablative Solutions, Inc.

Must be taking: Antihypertensives

Must not be taking: NSAIDs, Immunosuppressives, Steroids

Disqualifiers: Renal abnormalities, Heart failure, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 8 weeks

142 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for treating high blood pressure using a dehydrated alcohol injection. The goal is to determine if this treatment can safely lower blood pressure without regular medication. Participants will either receive the treatment or undergo a simple procedure without the injection, allowing researchers to compare results. Suitable candidates have high blood pressure not well-controlled with one or two medications and are willing to stop these medications for a few months. As a Phase 3 trial, this treatment is in the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking advancements in blood pressure management.

Will I have to stop taking my current medications?

Yes, you will need to stop taking your current blood pressure medications for at least 13 weeks, which includes a 5-week period before the procedure and an 8-week period after the procedure.

What prior data suggests that this method is safe for hypertensive subjects?

Research has shown that using dehydrated alcohol for renal artery denervation, a procedure to treat high blood pressure, is generally safe. Studies have found that this method can lower blood pressure without major safety concerns. In one study, patients experienced a noticeable drop in their blood pressure over 24 hours. Importantly, this treatment demonstrated a good safety record, with serious side effects being rare. Another study showed that using dehydrated alcohol in this procedure safely reduced blood pressure over a longer period. This evidence suggests that the treatment is well-tolerated in people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for high blood pressure?

Unlike the standard treatments for high blood pressure, which typically involve medications like ACE inhibitors, beta-blockers, or calcium channel blockers, this new approach uses dehydrated alcohol injected directly into the renal arteries. This method works by targeting the nerves in the renal artery to disrupt signals that contribute to high blood pressure. Researchers are excited about this treatment because it offers a potential alternative for patients who don't respond well to traditional medications, and it might provide more lasting blood pressure control with a one-time procedure.

What evidence suggests that renal denervation by dehydrated alcohol injection is effective for high blood pressure?

This trial will compare the effects of renal denervation using dehydrated alcohol injection with a sham control. Research has shown that renal denervation with dehydrated alcohol can help lower blood pressure. Studies have found that this method leads to a small but significant drop in blood pressure over 24 hours. Specifically, one study showed that participants experienced an average decrease of 10 mmHg in blood pressure three months after treatment. This method appears safe and effective, with no major increase in complications. Overall, alcohol-based renal denervation shows promise for lowering high blood pressure when traditional medications are not used. ^{1 2 6 7 8}

Who Is on the Research Team?

Atul Pathak, Prof.

Principal Investigator

Princess Grace Hospital, Monaco

Felix Mahfoud, Prof.Dr. med

Principal Investigator

University of Basel

Michael Weber, MD

Principal Investigator

SUNY Downstate Medical Center and College of Medicine

David Kandzari, MD

Principal Investigator

Piedmont Healthcare

Are You a Good Fit for This Trial?

The RADAR trial is for adults with uncontrolled high blood pressure, specifically those with office SBP between 150-180 mmHg and DBP over 90 mmHg. Participants must be on 1 or 2 blood pressure meds but willing to stop them for at least 13 weeks around the procedure. They also need a certain range of blood pressure when measured over 24 hours.

Inclusion Criteria

Has 2 office blood pressure measurements with a mean office systolic blood pressure (SBP) of ≥150 mmHg and ≤180 mmHg, AND a mean office diastolic blood pressure (DBP) of ≥90 mmHg

I am willing to stop my blood pressure medicine for 13 weeks.

Has a mean 24-hour ambulatory SBP of ≥140 mmHg and ≤170 mmHg with required valid readings

Exclusion Criteria

Is pregnant or lactating at the time of enrollment or planning to become pregnant during the trial time period (female subjects only)

My kidneys have abnormal blood vessel structures.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Run-in Period

Participants take no antihypertensive medications to confirm eligibility

4 weeks

Treatment

Participants undergo renal denervation or sham procedure

8 weeks

1 visit (in-person)

Follow-up

Participants are monitored for changes in blood pressure and safety

6 months

Multiple visits (in-person and virtual)

Crossover (optional)

Participants in the Sham Control Arm may crossover to the Treatment Arm

What Are the Treatments Tested in This Trial?

Interventions

• Dehydrated Alcohol Injection

Trial Overview This study tests the safety and effectiveness of renal denervation using dehydrated alcohol injection without antihypertensive drugs. It involves a comparison between this new treatment and a sham (fake) procedure to see if there's an improvement in blood pressure control.

How Is the Trial Designed?

Group I: Treatment Arm Experimental Treatment 1 Intervention

Renal denervation performed with dehydrated alcohol injection, USP administered via the Peregrine System™ Infusion Catheter.

Group II: Sham Control Arm Placebo Group 1 Intervention

Only renal angiography performed

Who Is Running the Clinical Trial?

Ablative Solutions, Inc.

Lead Sponsor

Trials

4

Recruited

710+

Citations

1. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.124.069291

Effect of Alcohol-Mediated Renal Denervation on Blood ... Alcohol-mediated RDN was associated with a modest but statistically significant reduction in 24-hour ambulatory SBP compared with sham control.

2. nature.com nature.com/articles/s44161-024-00476-2

Alcohol-mediated renal denervation is a safe and efficient ... Alcohol-mediated RDN was associated with a modest but significant reduction in 24-hour ambulatory systolic blood pressure with favorable safety.

3. ahajournals.org ahajournals.org/doi/10.1161/CIRCINTERVENTIONS.120.010075

Long-Term Results up to 12 Months After Catheter-Based ... Conclusions: Catheter-based chemical renal denervation with dehydrated alcohol using the Peregrine Catheter seems to safely reduce BP at follow- ...

4. acc.org acc.org/About-ACC/Press-Releases/2024/04/08/14/34/trial-reports-mixed-results-with-nerve-ablation-for-high-blood-pressure

Trial Reports Mixed Results with Nerve Ablation for High ... At three months after the procedure, 24-hour ambulatory systolic blood pressure dropped by 10 mmHg, on average, among participants who received ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11871512/

Renal Denervation Effects on Blood Pressure in Resistant and ... RDN significantly reduced several SBP and DBP outcomes versus sham without significantly increasing complications. This makes RDN a potentially effective ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0735109723066512

Safety and Efficacy of Renal Denervation in Patients ... RDN was associated with a reduction in office systolic BP compared with sham control at 6 months (adjusted treatment difference: −4.9 mm Hg; P = 0.0015). Night- ...

7. acc.org acc.org/Latest-in-Cardiology/Articles/2024/04/02/17/02/mon-11am-target-bp-acc-2024

TARGET BP I: Does New Renal Denervation System ... A new renal denervation system (RDN) that uses dehydrated alcohol modestly but significantly lowered 24-hour ambulatory systolic blood pressure (SBP) at three ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT07083765

Study Details | NCT07083765 | Renal Artery Denervation ... Study Overview. Brief Summary. To obtain an assessment of the efficacy and safety of renal denervation by dehydrated alcohol injection, USP administered via ...