TARGET BP I Clinical Trial

Hypertension Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02910414
• Other study ID #: CR0002
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: July 22, 2019
• Est. completion date: May 2026

Study information

• Verified date: October 2023
• Source: Ablative Solutions, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: May 2026
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. 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.

2. Has a mean 24-hour ambulatory SBP of =135 mmHg and =170 mmHg with =70% valid readings

Exclusion Criteria:

1. Subject has renal artery anatomy abnormalities.

2. 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.

3. Subject has documented sleep apnea.

4. 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).

5. Subject is pregnant or lactating at the time of enrollment or planning to become pregnant during the trial time period (female subjects only).

6. 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.

7. Subject has a history of myocardial infarction, unstable angina pectoris, or stroke/TIA within 6 months prior to the planned procedure.

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Dehydrated alcohol
Dehydrated Alcohol Injection, USP is used in the study.

Device:
• Peregrine System Kit (Sham Procedure)
Pre-procedural diagnostic renal angiography only, performed for confirmation of anatomical eligibility prior to randomization

Locations

Country	Name	City	State
United States	Piedmont Heart Institute	Atlanta	Georgia
United States	Cardiology PC	Birmingham	Alabama
United States	UT Southwestern Medical Center	Dallas	Texas
United States	NC Heart and Vascular Research	Raleigh	North Carolina
United States	Wake Forest University Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Ablative Solutions, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in mean systolic ABPM	The change in mean 24-hour ambulatory SBP from baseline to 3 months post-procedure	3 months
Secondary	Proportion of subjects with major adverse events	Major Adverse Events as defined in the clinical protocol	30 days
Secondary	Major Adverse Events	Major Adverse Events as defined in the clinical protocol	3, 6, and 12 months and 2 and 3 years
Secondary	Decrease in eGFR > 25%	Decrease in eGFR > 25% at 3 and 6 months	3 and 6 months
Secondary	Changes in eGFR	Changes in eGFR at 3 and 6 months	3 and 6 months
Secondary	Adverse event rate	Adverse event rate at procedure, discharge, and at all follow-up visits	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
Secondary	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 date (day 0)
Secondary	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.	Hospital discharge date (an average of 1 day)
Secondary	Change of office systolic blood pressure	Change of office systolic blood pressure from baseline to 8 weeks	8 weeks
Secondary	Change of diastolic office blood pressure	Change of diastolic office blood pressure from baseline to 3 and 6 months	3 and 6 months
Secondary	Change of 24-hour mean diastolic ABPM	Change of 24-hour mean diastolic ABPM from baseline to 3 and 6 months	3 and 6 months
Secondary	Change of 24-hour mean systolic ABPM	Change of 24-hour mean systolic ABPM from baseline to 6 months	6 months
Secondary	Changes in antihypertensive regimen	Changes in antihypertensive regimen from procedure to 3 months post-procedure	3 months
Secondary	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.	3 months
Secondary	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.	3 months
Secondary	Change in mean office SBP	Change in mean office SBP from baseline to 6 months post-procedure	6 months
Secondary	Change in mean daytime ambulatory SBP	Change in mean daytime ambulatory SBP from baseline to 3 months post procedure.	3 months
Secondary	Change in mean daytime ambulatory SBP	Change in mean daytime ambulatory SBP from baseline to 6 months post procedure.	6 months
Secondary	Change in mean daytime ambulatory DBP	Change in mean daytime ambulatory DBP from baseline to 3 months and then 6 months post procedure.	3 and 6 months
Secondary	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).	3 and 6 months
Secondary	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)	6 months
Secondary	Change in mean nighttime ambulatory SBP	Change in mean nighttime ambulatory SBP from baseline to 3 months and then 6 months post procedure.	3 and 6 months
Secondary	Change in mean nighttime ambulatory DBP	Change in mean nighttime ambulatory DBP from baseline to 3 months and then 6 months post procedure.	3 and 6 months
Secondary	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.	3, 6, and 12 months