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Drug

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

Phase 3

Waitlist Available

Led By Atul Pathak, MD

Research Sponsored by Ablative Solutions, Inc.

Eligibility Criteria Checklist

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

Must have

Has 3 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 when receiving 2 to 5 antihypertensive medications.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3, 6, and 12 months and 2 and 3 years

Awards & highlights

TARGET BP I Trial Summary

This trial is testing whether a treatment called renal denervation can help lower blood pressure in people who have uncontrolled hypertension. The trial will compare people who receive the treatment to those who don't, and will be conducted via central randomization.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While specific side effects aren't listed here, procedures like renal denervation could potentially cause discomfort at the catheter insertion site, bleeding, infection risk and possibly impact kidney function.

TARGET BP I Trial Eligibility Criteria

Inclusion Criteria

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

Select...

My average blood pressure is between 150/90 and 180/90 mmHg while on 2-5 blood pressure medications.

TARGET BP I Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3, 6, and 12 months and 2 and 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3, 6, and 12 months and 2 and 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 6, and 12 months and 2 and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in mean systolic ABPM

Secondary outcome measures

ABPM responders (5 mmHg)

Adverse event rate

Change in mean daytime ambulatory DBP

+19 more

TARGET BP I Trial Design

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).

0 / 1Eligibility criteria met

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Who is running the clinical trial?

Ablative Solutions, Inc.Lead Sponsor

3 Previous Clinical Trials

145 Total Patients Enrolled

Atul Pathak, MDPrincipal InvestigatorClinique Pasteur

1 Previous Clinical Trials

109 Total Patients Enrolled

Felix Mahfoud, MDPrincipal InvestigatorKlinik fur Innere Medizin III

6 Previous Clinical Trials

3,829 Total Patients Enrolled

Media Library

Dehydrated alcohol (Drug) Clinical Trial Eligibility Overview. Trial Name: NCT02910414 — Phase 3

High Blood Pressure Research Study Groups: Treated with Peregrine System Kit, Renal Angiography Only (Sham Procedure)

High Blood Pressure Clinical Trial 2023: Dehydrated alcohol Highlights & Side Effects. Trial Name: NCT02910414 — Phase 3

Dehydrated alcohol (Drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02910414 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do the participants of this study have to be a certain age?

"This study is looking for willing participants who are between 18-80 years old."

Answered by AI

Is dehydrated alcohol a new ingredient in medical research?

"The effects of dehydrated alcohol have been investigated in 139 clinical trials since 2004, with 45 of these trials ongoing. Much of the recent research has been conducted in Winston-Salem, North carolina."

Answered by AI

Is this study popular in the United States?

"The trial is running in Winston-Salem, Atlanta, Raleigh and a few other locations. The sponsor of the trial suggests that patients enroll at the location that is closest to them, to minimize travel requirements."

Answered by AI

Has the FDA cleared dehydrated alcohol for medical use?

"There is both pre-existing evidence of Dehydrated alcohol's efficacy as well as data supporting its safety, so it received a score of 3."

Answered by AI

What medical conditions does dehydrated alcohol commonly alleviate?

"Dehydrated alcohol is often used to treat obstructive hypertrophic cardiomyopathy. It can also be taken to treat various conditions like communicable diseases, ethylene glycol, and skin disinfection therapy."

Answered by AI

How can individuals sign up for this experiment?

"Yes, this trial is still looking for participants. The listing on clinicaltrials.gov shows that the study was originally posted on 7/22/2019 and was most recently updated on 6/8/2022."

Answered by AI

Are there any requirements to enroll in this trial?

"This clinical trial has already enrolled 300 participants and is still looking for more. In order to be eligible, potential candidates must have hypertension and be between 18 and 80 years old."

Answered by AI