Renal Denervation for High Blood Pressure
(TARGET BP I Trial)

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen byDavid Kandzari, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Ablative Solutions, Inc.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

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.

Research Team

David Kandzari, MD

Principal Investigator

Piedmont Heart Institute

Felix Mahfoud, MD

Principal Investigator

Klinik fur Innere Medizin III

Michael Weber, MD

Principal Investigator

SUNY Downstate Medical

Atul Pathak, MD

Principal Investigator

Clinique Pasteur

Eligibility Criteria

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

Treatment Details

Interventions

Dehydrated alcohol (Drug)
Peregrine System Kit (Device)

Trial OverviewThe 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.

Participant Groups

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).