Renal Denervation for High Blood Pressure
(TARGET BP I 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?
How is the treatment for high blood pressure using the Peregrine System Kit different from other treatments?
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 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
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive renal denervation with the Peregrine System Kit or undergo a sham procedure
Follow-up
Participants are monitored for safety and effectiveness after treatment
Extended Follow-up
Long-term monitoring of participants for adverse events and blood pressure changes
What Are the Treatments Tested in This Trial?
Interventions
- Dehydrated alcohol
- Peregrine System Kit
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ablative Solutions, Inc.
Lead Sponsor