The TARGET BP OFF-MED Trial

NCT03503773 | Completed Phase 2 Results DMC

• 1 other identifier: CR0014
• Study Type: interventional
• Target: 350
• Locations: 4 countries
• Sites: 4

Brief Summary

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.

Conditions

Hypertension; Hypertension,Essential

Keywords

Renal Denervation; Neurolysis

Outcome Measures

Primary Outcomes (1)

• Changes in Systolic Ambulatory Blood Pressure

  Change from baseline in mean 24-hour ambulatory systolic blood pressure

  Baseline to 8 weeks post-treatment

Secondary Outcomes (25)

• Change in Mean 24-Hour Ambulatory Systolic Blood Pressure at 6 Months

  6 months

• Change in Mean 24-Hour Ambulatory Systolic Blood Pressure at 12 Months

  12 months

• Change in Office SBP at 8 Weeks

  8 weeks

• Change in Mean 24-Hour Ambulatory Diastolic Blood Pressure at 8 Weeks

  8 weeks

• Change in Mean 24-Hour Ambulatory Diastolic Blood Pressure at 6 Months

  6 months

Study Arms (2)

Treatment Arm:

EXPERIMENTAL

Renal denervation (using the Peregrine Kit) performed with alcohol infused through the Peregrine Catheter

Drug: Alcohol

Sham Control Arm

SHAM COMPARATOR

Only renal angiography performed

Other: Sham control

Interventions

Alcohol DRUG

Alcohol is directly infused/delivered to the adventitial and periadventitial space of the renal arteries

Treatment Arm:

Sham control OTHER

endovascular, renal angiography

Sham Control Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Subject is willing to discontinue any current antihypertensive medications during the run-in period and the post-treatment period.
• Has a mean 24-hour ambulatory SBP of ≥135 mmHg and ≤170 mmHg with ≥70% valid readings

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ablative Solutions, Inc.: lead

Study Sites (4)

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Clinique Pasteur Toulouse

Toulouse, France

Location

Universitätsklinikum des Saarlandes

Homburg/Saar, 66421, Germany

Location

NIHR Barts Cardiovascular Biomedical Research Unit

London, EC1M 6BQ, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 37427416 BACKGROUND

• 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.

  PMID: 32958438 DERIVED

MeSH Terms

Conditions

Hypertension; Essential Hypertension

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Results Point of Contact

• Title: Kate Rumrill, CEO
• Organization: Ablative Solutions Inc

krumrill@ablativesolutions.com

1 650-688-9743

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Blinded (The subject, sponsor, and hypertensionist/nephrologist performing the screening and follow-up assessments are blinded. The interventionalist and cath lab staff are unblinded.)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects who continue to be eligible at the end of the run-in period will be randomized in a 1:1 ratio to one of the following 2 groups via central randomization (stratified by study site): * Treatment Arm: renal denervation (using the Peregrine Kit) performed with alcohol infused through the Peregrine Catheter * Sham Control Arm: only renal angiography performed

Study Record Dates

• First Submitted: March 23, 2018
• First Posted: April 20, 2018
• Study Start: September 24, 2018
• Primary Completion: January 31, 2022
• Study Completion: January 10, 2024
• Last Updated: May 14, 2025
• Results First Posted: October 4, 2024

Record last verified: 2025-05

Locations

DE (1); FR (1); GB (1); BE (1)