Back to resultsTARGET BP I Clinical Trial (TARGET BP I)
Primary Purpose
Hypertension
Status
Active
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Dehydrated alcohol
Peregrine System Kit (Sham Procedure)
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension focused on measuring Renal Denervation, Alcohol
Eligibility Criteria
Inclusion Criteria:
- 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.
- Has a mean 24-hour ambulatory SBP of ≥135 mmHg and ≤170 mmHg with ≥70% valid readings
Exclusion Criteria:
- Subject has renal artery anatomy abnormalities.
- Subject has an estimated glomerular filtration rate (eGFR) of ≤45 mL/min/1.73 m2, based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation; or is on chronic renal replacement therapy.
- Subject has documented sleep apnea.
- Subject has any of the following conditions: severe cardiac valve stenosis, heart failure (New York Heart Association [NYHA] Class III or IV), chronic atrial fibrillation, and known primary pulmonary hypertension (>60 mmHg pulmonary artery or right ventricular systolic pressure).
- Subject is pregnant or lactating at the time of enrollment or planning to become pregnant during the trial time period (female subjects only).
- Subject is being treated chronically (e.g. daily use) with NSAIDs, immunosuppressive medications, or immunosuppressive doses of steroids. Aspirin therapy and nasal pulmonary inhalants are allowed.
- Subject has a history of myocardial infarction, unstable angina pectoris, or stroke/TIA within 6 months prior to the planned procedure.
Sites / Locations
- Cardiology PC
- Piedmont Heart Institute
- NC Heart and Vascular Research
- Wake Forest University Baptist Medical Center
- UT Southwestern Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Treated with Peregrine System Kit
Renal Angiography Only (Sham Procedure)
Arm Description
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.
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).
Outcomes
Primary Outcome Measures
Change in mean systolic ABPM
The change in mean 24-hour ambulatory SBP from baseline to 3 months post-procedure
Secondary Outcome Measures
Proportion of subjects with major adverse events
Major Adverse Events as defined in the clinical protocol
Major Adverse Events
Major Adverse Events as defined in the clinical protocol
Decrease in eGFR > 25%
Decrease in eGFR > 25% at 3 and 6 months
Changes in eGFR
Changes in eGFR at 3 and 6 months
Adverse event rate
Adverse event rate at procedure, discharge, and at all follow-up visits
Device success
Device success, defined as successful introduction of the catheter, navigation to the treatment site, deployment of the needles, and infusion of the alcohol to the intended area via the Peregrine Catheter as intended for use
Procedure success
Procedure success defined as device success and freedom from serious adverse events related to the product or the procedure, during the procedure and prior to hospital discharge from the index procedure.
Change of office systolic blood pressure
Change of office systolic blood pressure from baseline to 8 weeks
Change of diastolic office blood pressure
Change of diastolic office blood pressure from baseline to 3 and 6 months
Change of 24-hour mean diastolic ABPM
Change of 24-hour mean diastolic ABPM from baseline to 3 and 6 months
Change of 24-hour mean systolic ABPM
Change of 24-hour mean systolic ABPM from baseline to 6 months
Changes in antihypertensive regimen
Changes in antihypertensive regimen from procedure to 3 months post-procedure
ABPM responders (5 mmHg)
ABPM Responders, defined as the proportion of subjects with a drop of ≥5 mmHg in 24-hour ambulatory SBP at 3 months compared with baseline.
Office BP responders (10 mmHg)
Office BP Responders, defined as the proportion of subjects with a drop of ≥10 mmHg in office SBP at 3 months compared with baseline.
Change in mean office SBP
Change in mean office SBP from baseline to 6 months post-procedure
Change in mean daytime ambulatory SBP
Change in mean daytime ambulatory SBP from baseline to 3 months post procedure.
Change in mean daytime ambulatory SBP
Change in mean daytime ambulatory SBP from baseline to 6 months post procedure.
Change in mean daytime ambulatory DBP
Change in mean daytime ambulatory DBP from baseline to 3 months and then 6 months post procedure.
Changes (decreases or increases) in antihypertensive medication regimen from 3 months to 6 months post-procedure
Changes (decreases or increases) in antihypertensive medication regimen from 3 months to 6 months post-procedure (titrated according to standardized formula to maintain a target office SBP of < 140 mmHg and ≥ 90 mmHg).
Changes (decreases or increases) in antihypertensive medication regimen from procedure to 6 months post-procedure
Changes (decreases or increases) in antihypertensive medication regimen from procedure to 6 months post-procedure (titrated according to standardized formula to maintain a target office SBP of <140 mmHg and ≥90 mmHg)
Change in mean nighttime ambulatory SBP
Change in mean nighttime ambulatory SBP from baseline to 3 months and then 6 months post procedure.
Change in mean nighttime ambulatory DBP
Change in mean nighttime ambulatory DBP from baseline to 3 months and then 6 months post procedure.
Reduction of office SBP and DBP to normal
Reduction of office SBP and DBP to normal (<140/90 mmHg) at 3, 6 and 12 months as compared to baseline.
Full Information
NCT ID
NCT02910414
First Posted
September 16, 2016
Last Updated
October 2, 2023
Sponsor
Ablative Solutions, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02910414
Brief Title
TARGET BP I Clinical Trial
Acronym
TARGET BP I
Official Title
A Pivotal, Multicenter, Blinded, Sham Procedure-Controlled Trial of Renal Denervation by the Peregrine System™ Kit, in Subjects With Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 22, 2019 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
May 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ablative Solutions, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
The TARGET BP I clinical trial uses a percutaneous catheter to deliver very small amounts of alcohol (neurolytic agent). The patient population for this trial is comparable to those used in other renal denervation studies, but also incorporates lessons learned from recent trials of renal denervation. This is to enable the study of an optimized patient population who stands to benefit from the intervention, in a manner that reduces possible study bias.
This trial is intended to evaluate the safety and efficacy of the Peregrine Catheter when used to deliver a 0.6 mL volume of alcohol to the perivascular area of the respective renal arteries while patients are adequately managed with oral antihypertensive medications.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Renal Denervation, Alcohol
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treated with Peregrine System Kit
Arm Type
Experimental
Arm Description
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.
Arm Title
Renal Angiography Only (Sham Procedure)
Arm Type
Sham Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Dehydrated alcohol
Other Intervention Name(s)
Ethanol
Intervention Description
Dehydrated Alcohol Injection, USP is used in the study.
Intervention Type
Device
Intervention Name(s)
Peregrine System Kit (Sham Procedure)
Intervention Description
Pre-procedural diagnostic renal angiography only, performed for confirmation of anatomical eligibility prior to randomization
Primary Outcome Measure Information:
Title
Change in mean systolic ABPM
Description
The change in mean 24-hour ambulatory SBP from baseline to 3 months post-procedure
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Proportion of subjects with major adverse events
Description
Major Adverse Events as defined in the clinical protocol
Time Frame
30 days
Title
Major Adverse Events
Description
Major Adverse Events as defined in the clinical protocol
Time Frame
3, 6, and 12 months and 2 and 3 years
Title
Decrease in eGFR > 25%
Description
Decrease in eGFR > 25% at 3 and 6 months
Time Frame
3 and 6 months
Title
Changes in eGFR
Description
Changes in eGFR at 3 and 6 months
Time Frame
3 and 6 months
Title
Adverse event rate
Description
Adverse event rate at procedure, discharge, and at all follow-up visits
Time Frame
Procedure date, discharge date (an average of 1 day), 5-day, 4 weeks, 8 weeks, 3 months, 4 months, 5 months, 6 months, 1 year, 2 years and 3 years
Title
Device success
Description
Device success, defined as successful introduction of the catheter, navigation to the treatment site, deployment of the needles, and infusion of the alcohol to the intended area via the Peregrine Catheter as intended for use
Time Frame
Procedure date (day 0)
Title
Procedure success
Description
Procedure success defined as device success and freedom from serious adverse events related to the product or the procedure, during the procedure and prior to hospital discharge from the index procedure.
Time Frame
Hospital discharge date (an average of 1 day)
Title
Change of office systolic blood pressure
Description
Change of office systolic blood pressure from baseline to 8 weeks
Time Frame
8 weeks
Title
Change of diastolic office blood pressure
Description
Change of diastolic office blood pressure from baseline to 3 and 6 months
Time Frame
3 and 6 months
Title
Change of 24-hour mean diastolic ABPM
Description
Change of 24-hour mean diastolic ABPM from baseline to 3 and 6 months
Time Frame
3 and 6 months
Title
Change of 24-hour mean systolic ABPM
Description
Change of 24-hour mean systolic ABPM from baseline to 6 months
Time Frame
6 months
Title
Changes in antihypertensive regimen
Description
Changes in antihypertensive regimen from procedure to 3 months post-procedure
Time Frame
3 months
Title
ABPM responders (5 mmHg)
Description
ABPM Responders, defined as the proportion of subjects with a drop of ≥5 mmHg in 24-hour ambulatory SBP at 3 months compared with baseline.
Time Frame
3 months
Title
Office BP responders (10 mmHg)
Description
Office BP Responders, defined as the proportion of subjects with a drop of ≥10 mmHg in office SBP at 3 months compared with baseline.
Time Frame
3 months
Title
Change in mean office SBP
Description
Change in mean office SBP from baseline to 6 months post-procedure
Time Frame
6 months
Title
Change in mean daytime ambulatory SBP
Description
Change in mean daytime ambulatory SBP from baseline to 3 months post procedure.
Time Frame
3 months
Title
Change in mean daytime ambulatory SBP
Description
Change in mean daytime ambulatory SBP from baseline to 6 months post procedure.
Time Frame
6 months
Title
Change in mean daytime ambulatory DBP
Description
Change in mean daytime ambulatory DBP from baseline to 3 months and then 6 months post procedure.
Time Frame
3 and 6 months
Title
Changes (decreases or increases) in antihypertensive medication regimen from 3 months to 6 months post-procedure
Description
Changes (decreases or increases) in antihypertensive medication regimen from 3 months to 6 months post-procedure (titrated according to standardized formula to maintain a target office SBP of < 140 mmHg and ≥ 90 mmHg).
Time Frame
3 and 6 months
Title
Changes (decreases or increases) in antihypertensive medication regimen from procedure to 6 months post-procedure
Description
Changes (decreases or increases) in antihypertensive medication regimen from procedure to 6 months post-procedure (titrated according to standardized formula to maintain a target office SBP of <140 mmHg and ≥90 mmHg)
Time Frame
6 months
Title
Change in mean nighttime ambulatory SBP
Description
Change in mean nighttime ambulatory SBP from baseline to 3 months and then 6 months post procedure.
Time Frame
3 and 6 months
Title
Change in mean nighttime ambulatory DBP
Description
Change in mean nighttime ambulatory DBP from baseline to 3 months and then 6 months post procedure.
Time Frame
3 and 6 months
Title
Reduction of office SBP and DBP to normal
Description
Reduction of office SBP and DBP to normal (<140/90 mmHg) at 3, 6 and 12 months as compared to baseline.
Time Frame
3, 6, and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Has a mean 24-hour ambulatory SBP of ≥135 mmHg and ≤170 mmHg with ≥70% valid readings
Exclusion Criteria:
Subject has renal artery anatomy abnormalities.
Subject has an estimated glomerular filtration rate (eGFR) of ≤45 mL/min/1.73 m2, based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation; or is on chronic renal replacement therapy.
Subject has documented sleep apnea.
Subject has any of the following conditions: severe cardiac valve stenosis, heart failure (New York Heart Association [NYHA] Class III or IV), chronic atrial fibrillation, and known primary pulmonary hypertension (>60 mmHg pulmonary artery or right ventricular systolic pressure).
Subject is pregnant or lactating at the time of enrollment or planning to become pregnant during the trial time period (female subjects only).
Subject is being treated chronically (e.g. daily use) with NSAIDs, immunosuppressive medications, or immunosuppressive doses of steroids. Aspirin therapy and nasal pulmonary inhalants are allowed.
Subject has a history of myocardial infarction, unstable angina pectoris, or stroke/TIA within 6 months prior to the planned procedure.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Kandzari, MD
Organizational Affiliation
Piedmont Heart Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Weber, MD
Organizational Affiliation
SUNY Downstate Medical
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Atul Pathak, MD
Organizational Affiliation
Clinique Pasteur
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Felix Mahfoud, MD
Organizational Affiliation
Klinik fur Innere Medizin III
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiology PC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35211
Country
United States
Facility Name
Piedmont Heart Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
NC Heart and Vascular Research
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Wake Forest University Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32958438
Citation
Bertog S, Sharma A, Mahfoud F, Pathak A, Schmieder RE, Sievert K, Papademetriou V, Weber MA, Haratani N, Lobo MD, Saxena M, Kandzari DE, Fischell TA, Sievert H. Alcohol-Mediated Renal Sympathetic Neurolysis for the Treatment of Hypertension: The Peregrine Infusion Catheter. Cardiovasc Revasc Med. 2021 Mar;24:77-86. doi: 10.1016/j.carrev.2020.09.003. Epub 2020 Sep 7.
Results Reference
derived
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TARGET BP I Clinical Trial
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