300 Participants Needed

Renal Denervation for High Blood Pressure

(TARGET BP I Trial)

Recruiting at 4 trial locations
DR
DS
KC
KR
DK
FM
Overseen ByFarrell Mendelsohn, MD
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Ablative Solutions, Inc.
Must be taking: Antihypertensives
No Placebo GroupAll 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 DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The TARGET BP I Trial is a randomized, blinded, multi-center, international, sham-procedure controlled trial, comparing renal denervation performed with the Peregrine System Kit in the treatment group to the sham control group (without renal denervation - no alcohol infusion). Subjects will be randomized in a 1:1 fashion to treatment versus sham control via central randomization.

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

The trial does not specify if you need to stop your current medications, but it requires participants to be on 2 to 5 blood pressure medications. It seems you may continue your current blood pressure medications if they fall within this range.

Is alcohol-mediated renal denervation using the Peregrine System safe for humans?

Early clinical studies and trials have shown that using the Peregrine System for alcohol-mediated renal denervation is generally safe, with no significant safety issues reported during follow-ups.12345

How is the treatment for high blood pressure using the Peregrine System Kit different from other treatments?

This treatment uses a novel catheter system to deliver dehydrated alcohol directly to the nerves around the kidney arteries, which may provide more consistent nerve damage and reduce blood pressure more effectively than traditional methods like radiofrequency ablation.12367

What data supports the effectiveness of the treatment Dehydrated alcohol, Peregrine System Kit for high blood pressure?

Early clinical studies and animal research show that using the Peregrine System Kit to deliver alcohol to the kidney area can significantly lower blood pressure and cause consistent nerve damage, which may help control high blood pressure. Ongoing trials are further investigating these benefits.12348

Who Is on the Research Team?

David Edward Kandzari, MD - Atlanta, GA

David Kandzari, MD

Principal Investigator

Piedmont Heart Institute

FM

Felix Mahfoud, MD

Principal Investigator

Klinik fur Innere Medizin III

MW

Michael Weber, MD

Principal Investigator

SUNY Downstate Medical

AP

Atul Pathak, MD

Principal Investigator

Clinique Pasteur

Are You a Good Fit for This Trial?

This trial is for adults with high blood pressure, specifically those with a systolic reading between 150-180 mmHg and diastolic above 90 mmHg while on 2-5 blood pressure medications. Participants must also have certain ambulatory blood pressure readings. Those with kidney issues, sleep apnea, severe heart conditions, recent major cardiovascular events or who are pregnant/lactating cannot join.

Inclusion Criteria

My average blood pressure is between 150/90 and 180/90 mmHg while on 2-5 blood pressure medications.
Your average blood pressure over 24 hours is between 135 and 170 mmHg with at least 70% of the readings being accurate.

Exclusion Criteria

I have been diagnosed with sleep apnea.
I have severe heart or lung conditions.
My kidney function is low or I am on long-term dialysis.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive renal denervation with the Peregrine System Kit or undergo a sham procedure

Procedure date (day 0)
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months
Multiple visits at 5-day, 4 weeks, 8 weeks, 3 months

Extended Follow-up

Long-term monitoring of participants for adverse events and blood pressure changes

3 years
Visits at 4 months, 5 months, 6 months, 1 year, 2 years, and 3 years

What Are the Treatments Tested in This Trial?

Interventions

  • Dehydrated alcohol
  • Peregrine System Kit
Trial Overview The TARGET BP I Trial is testing the effectiveness of renal denervation using the Peregrine System Kit compared to a sham procedure (no real treatment). Participants will be randomly assigned to either receive the actual intervention or a fake one without knowing which group they're in.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Treated with Peregrine System KitExperimental Treatment1 Intervention
The experimental group will receive an infusion of Dehydrated Alcohol Injection, USP into the perivascular space of the renal arteries with the Peregrine Catheter. A total of 0.6mL of the alcohol will be delivered to the perivascular space of each renal artery. The drug will only be delivered once to each renal artery during the treatment procedure.
Group II: Renal Angiography Only (Sham Procedure)Placebo Group1 Intervention
The sham control group will only have diagnostic renal angiography performed. There will be no insertion of the Peregrine Catheter and no alcohol infusion (i.e. no renal denervation).

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ablative Solutions, Inc.

Lead Sponsor

Trials
4
Recruited
710+

Citations

Alcohol-Mediated Renal Denervation Using the Peregrine System Infusion Catheter for Treatment of Hypertension. [2020]
Alcohol-Mediated Renal Sympathetic Neurolysis for the Treatment of Hypertension: The Peregrine™ Infusion Catheter. [2021]
Randomised, blinded and controlled comparative study of chemical and radiofrequency-based renal denervation in a porcine model. [2017]
Catheter-based alcohol-mediated renal denervation for the treatment of uncontrolled hypertension: design of two sham-controlled, randomized, blinded trials in the absence (TARGET BP OFF-MED) and presence (TARGET BP I) of antihypertensive medications. [2021]
Renal Sympathetic Denervation by CT-Guided Ethanol Injection: A Phase II Pilot Trial of a Novel Technique. [2016]
Evaluation of Transcatheter Alcohol-Mediated Perivascular Renal Denervation to Treat Resistant Hypertension. [2020]
Ethanol-mediated perivascular renal sympathetic denervation: preclinical validation of safety and efficacy in a porcine model. [2022]
Next generation renal denervation: chemical "perivascular" renal denervation with alcohol using a novel drug infusion catheter. [2015]
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