The TARGET BP OFF-MED Trial

May 12, 2025 updated by: Ablative Solutions, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
350

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in Systolic Ambulatory Blood Pressure
Time Frame: Baseline to 8 weeks post-treatment
Change from baseline in mean 24-hour ambulatory systolic blood pressure
Baseline to 8 weeks post-treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Mean 24-Hour Ambulatory Systolic Blood Pressure at 6 Months
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 30 days post procedure
Number of participants with major adverse events (MAEs) 30 days post-procedure
30 days post procedure
Use of Antihypertensive Medication(s)
Time Frame: 8 weeks
Use of antihypertensive medication at 8 weeks
8 weeks
Change in Mean Daytime Ambulatory Systolic Blood Pressure at 8 Weeks
Time Frame: 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
Time Frame: 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
Time Frame: 12 months
Change from Baseline in Mean Daytime Ambulatory Systolic Blood Pressure to 12 Months
12 months
Mean Daytime Ambulatory Diastolic Blood Pressure
Time Frame: 8 weeks
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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 6 months
Change from Baseline in mean office SBP to 6 Months
6 months
Change in Mean Office SBP to 12 Months
Time Frame: 12 months
Change from Baseline in mean office SBP to 12 Months
12 months
Change in Mean Office DBP to 8 Weeks
Time Frame: 8 weeks
Change from Baseline in mean office DBP to 8 Weeks
8 weeks
Change in Mean Office DBP to 6 Months
Time Frame: 6 months
Change from Baseline in mean office DBP to 6 Months
6 months
Change in Mean Office DBP at 12 Months
Time Frame: 12 months
Change from Baseline in mean office DBP to 12 Months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ablative Solutions, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 24, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 10, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 23, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 20, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 14, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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