The TARGET BP OFF-MED Trial

A Phase 2, Multicenter, Blinded, Sham Procedure-Controlled Trial of Renal Denervation by the Peregrine System Kit, in Subjects With Hypertension, in the Absence of Antihypertensive Medications

To obtain an assessment of the efficacy and safety of renal denervation by alcohol-mediated neurolysis using the Peregrine Kit in hypertensive subjects in the absence of antihypertensive medications.

Study Overview

• Status: Completed
• Conditions: Hypertension; Hypertension,Essential
• Intervention / Treatment: Drug: Alcohol; Other: Sham control

• Study Type: Interventional
• Enrollment (Actual): 350
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1200
    • Cliniques universitaires Saint-Luc
• France
  • Toulouse, France
    • Clinique Pasteur Toulouse
• Germany
  • Homburg/Saar, Germany, 66421
    • Universitätsklinikum des Saarlandes
• United Kingdom
  • London, United Kingdom, EC1M 6BQ
    • NIHR Barts Cardiovascular Biomedical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Has 3 office blood pressure measurements with a mean office systolic blood pressure (SBP) of ≥140 mmHg and ≤180 mmHg, AND a mean office diastolic blood pressure (DBP) of ≥90 mmHg.
2. Subject is willing to discontinue any current antihypertensive medications during the run-in period and the post-treatment period.
3. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Arm: Renal denervation (using the Peregrine Kit) performed with alcohol infused through the Peregrine Catheter	Drug: Alcohol; Alcohol is directly infused/delivered to the adventitial and periadventitial space of the renal arteries
Sham Comparator: Sham Control Arm; Only renal angiography performed	Other: Sham control; endovascular, renal angiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Systolic Ambulatory Blood Pressure	Change from baseline in mean 24-hour ambulatory systolic blood pressure	Baseline to 8 weeks post-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Mean 24-Hour Ambulatory Systolic Blood Pressure at 6 Months	Change from baseline in mean 24-hour ambulatory systolic blood pressure from baseline to 6 months	6 months
Change in Mean 24-Hour Ambulatory Systolic Blood Pressure at 12 Months	Change from baseline in mean 24-hour systolic blood pressure at 12 months post-procedure	12 months
Change in Office SBP at 8 Weeks	Change from Baseline in mean office SBP to Week 8	8 weeks
Change in Mean 24-Hour Ambulatory Diastolic Blood Pressure at 8 Weeks	Change from baseline in mean 24-hour ambulatory diastolic blood pressure and 8 weeks post-procedure	8 weeks
Change in Mean 24-Hour Ambulatory Diastolic Blood Pressure at 6 Months	Change from baseline in mean 24-hour ambulatory diastolic blood pressure at 6 months post-procedure	6 months
Change in Mean 24-Hour Ambulatory Diastolic Blood Pressure at 12 Months	Change from baseline in mean 24-hour diastolic blood pressure 12 months post-procedure	12 months
Number of Participants With Major Adverse Events (MAEs)	Number of participants with major adverse events (MAEs) 30 days post-procedure	30 days post procedure
Use of Antihypertensive Medication(s)	Use of antihypertensive medication at 8 weeks	8 weeks
Change in Mean Daytime Ambulatory Systolic Blood Pressure at 8 Weeks	Change from Baseline in Mean Daytime Ambulatory Systolic Blood Pressure to 8 Weeks	8 weeks
Change in Mean Daytime Ambulatory Systolic Blood Pressure at 6 Months	Change from Baseline in Mean Daytime Ambulatory Systolic Blood Pressure to 6 Months	6 months
Change in Mean Daytime Ambulatory Systolic Blood Pressure at 12 Months	Change from Baseline in Mean Daytime Ambulatory Systolic Blood Pressure to 12 Months	12 months
Mean Daytime Ambulatory Diastolic Blood Pressure	Change from Baseline in Mean Daytime Ambulatory Diastolic Blood Pressure to 8 Weeks	8 weeks
Change in Mean Daytime Ambulatory Diastolic Blood Pressure at 6 Months	Change from Baseline in Mean Daytime Ambulatory Diastolic Blood Pressure to 6 months	6 months
Change in Mean Daytime Ambulatory Diastolic Blood Pressure at 12 Months	Change from Baseline in Mean Daytime Ambulatory Diastolic Blood Pressure to 12 Months	12 months
Change in Mean Nighttime Ambulatory Systolic Blood Pressure at 8 Weeks	Change from Baseline in Mean Nighttime Ambulatory Systolic Blood Pressure to 8 Weeks	8 weeks
Change in Mean Nighttime Ambulatory Systolic Blood Pressure at 6 Months	Change from Baseline in Mean Nighttime Ambulatory Systolic Blood Pressure to 6 Months	6 months
Change in Mean Nighttime Ambulatory Systolic Blood Pressure to 12 Months	Change from Baseline in Mean Nighttime Ambulatory Systolic Blood Pressure to 12 Months	12 months
Change in Mean Nighttime Ambulatory Diastolic Blood Pressure at 8 Weeks	Change from Baseline in Mean Nighttime Ambulatory Diastolic Blood Pressure to 8 weeks	8 weeks
Change in Mean Nighttime Ambulatory Diastolic Blood Pressure at 6 Months	Change from Baseline in Mean Nighttime Ambulatory Diastolic Blood Pressure to 6 Months	6 months
Change in Mean Nighttime Ambulatory Diastolic Blood Pressure at 12 Months	Change from Baseline in Mean Nighttime Ambulatory Diastolic Blood Pressure to 12 Months	12 months
Change in Mean Office SBP at 6 Months	Change from Baseline in mean office SBP to 6 Months	6 months
Change in Mean Office SBP to 12 Months	Change from Baseline in mean office SBP to 12 Months	12 months
Change in Mean Office DBP to 8 Weeks	Change from Baseline in mean office DBP to 8 Weeks	8 weeks
Change in Mean Office DBP to 6 Months	Change from Baseline in mean office DBP to 6 Months	6 months
Change in Mean Office DBP at 12 Months	Change from Baseline in mean office DBP to 12 Months	12 months

Collaborators and Investigators

• Sponsor: Ablative Solutions, Inc.
• Investigators: Principal Investigator: Felix Mahfoud, Prof.Dr.med., Universitätsklinikum des Saarlandes Klinik für Innere Medizin III Kardiologie, Angiologie und Internistische Intensivmedizin, Germany; Principal Investigator: Atul Pathak, Prof., Clinique Pasteur Hi-LAB, Toulouse, France

Publications and helpful links

General Publications

• 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.
• Pathak A, Rudolph UM, Saxena M, Zeller T, Muller-Ehmsen J, Lipsic E, Schmieder RE, Sievert H, Halbach M, Sharif F, Parise H, Fischell TA, Weber MA, Kandzari DE, Mahfoud F. Alcohol-mediated renal denervation in patients with hypertension in the absence of antihypertensive medications. EuroIntervention. 2023 Sep 18;19(7):602-611. doi: 10.4244/EIJ-D-23-00088.

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2018
• Primary Completion (Actual): January 31, 2022
• Study Completion (Actual): January 10, 2024

Study Registration Dates

• First Submitted: March 23, 2018
• First Submitted That Met QC Criteria: April 13, 2018
• First Posted (Actual): April 20, 2018

Study Record Updates

• Last Update Posted (Actual): May 14, 2025
• Last Update Submitted That Met QC Criteria: May 12, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Renal Denervation; Neurolysis
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Essential Hypertension; Hypertension
• Other Study ID Numbers: CR0014

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No