Clinical trial NCT02910414: TARGET BP I Clinical Trial
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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Hypertension
Keywords: Renal Denervation
Alcohol
Lead sponsor: Ablative Solutions, Inc.
Sponsor class: INDUSTRY
First posted: 2016-09-22
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in mean systolic ABPM
timeFrame: 3 months
Secondary outcomes:
measure: Proportion of subjects with major adverse events
timeFrame: 30 days
measure: Major Adverse Events
timeFrame: 3, 6, and 12 months and 2 and 3 years
measure: Decrease in eGFR > 25%
timeFrame: 3 and 6 months
measure: Changes in eGFR
timeFrame: 3 and 6 months
measure: Adverse event rate
timeFrame: 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
measure: Device success
timeFrame: Procedure date (day 0)
measure: Procedure success
timeFrame: Hospital discharge date (an average of 1 day)
measure: Change of office systolic blood pressure
timeFrame: 8 weeks
measure: Change of diastolic office blood pressure
timeFrame: 3 and 6 months
measure: Change of 24-hour mean diastolic ABPM
timeFrame: 3 and 6 months
measure: Change of 24-hour mean systolic ABPM
timeFrame: 6 months
measure: Changes in antihypertensive regimen
timeFrame: 3 months
measure: ABPM responders (5 mmHg)
timeFrame: 3 months
measure: Office BP responders (10 mmHg)
timeFrame: 3 months
measure: Change in mean office SBP
timeFrame: 6 months
measure: Change in mean daytime ambulatory SBP
timeFrame: 3 months
measure: Change in mean daytime ambulatory SBP
timeFrame: 6 months
measure: Change in mean daytime ambulatory DBP
timeFrame: 3 and 6 months
measure: Changes (decreases or increases) in antihypertensive medication regimen from 3 months to 6 months post-procedure
timeFrame: 3 and 6 months
measure: Changes (decreases or increases) in antihypertensive medication regimen from procedure to 6 months post-procedure
timeFrame: 6 months
measure: Change in mean nighttime ambulatory SBP
timeFrame: 3 and 6 months
measure: Change in mean nighttime ambulatory DBP
timeFrame: 3 and 6 months
measure: Reduction of office SBP and DBP to normal
timeFrame: 3, 6, and 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cardiology PC
state: Alabama
city: Atlanta
country: United States
facility: Piedmont Heart Institute
state: Georgia
city: Raleigh
country: United States
facility: NC Heart and Vascular Research
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Baptist Medical Center
state: North Carolina
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: Piedmont Heart Institute
name: David Kandzari, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: SUNY Downstate Medical
name: Michael Weber, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinique Pasteur
name: Atul Pathak, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Klinik fur Innere Medizin III
name: Felix Mahfoud, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.