🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the USA / NCT02910414
Active, not recruiting Phase 3

TARGET BP I Clinical Trial

NCT02910414 · tracked via the Priya Life Science USA tracker
Sponsor
Ablative Solutions, Inc.
Phase
Phase 3
Started
2019-07-22
Last updated
2023-10-03

Condition(s) studied

Hypertension

Investigational drug(s) / intervention(s)

Dehydrated alcoholPeregrine System Kit (Sham Procedure)

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

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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 outcome measure(s)

Trial sites (5)

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

More Ablative Solutions, Inc. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02910414 on ClinicalTrials.gov ↗ ← All trials in the USA