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The TARGET BP OFF-MED Trial | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

NCT03503773•Ablative Solutions, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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.

Locations (4)

Cliniques Universitaires Saint-Luc

Brussels, Belgium

Clinique Pasteur Toulouse

Toulouse, France

Universitätsklinikum des Saarlandes

Homburg/Saar, Germany

NIHR Barts Cardiovascular Biomedical Research Unit

London, United Kingdom

Key Dates

Start Date

September 24, 2018

Primary Completion Date

January 31, 2022

Completion Date

January 10, 2024

Last Updated

May 14, 2025

Enrollment

350

ACTUAL participants

Conditions

HypertensionHypertension,Essential

Interventions

Alcohol

DRUG

Sham control

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 14, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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The TARGET BP OFF-MED Trial

Inclusion Criteria

Exclusion Criteria

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