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Completed

NCT Number: NCT03503773

The TARGET BP OFF-MED Trial

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.

Completed

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Key information

Conditions

Hypertension Cardiovascular Diseases Essential Hypertension Hypertension,Essential Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cliniques Universitaires Saint-Luc, Brussels, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Alcohol

Drug

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

Sham control

Other

endovascular, renal angiography

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. Change in Office SBP at 8 Weeks

    Time frame: 8 weeks

    Change from Baseline in mean office SBP to Week 8

  4. 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

  5. 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. 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

  7. 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

  8. Use of Antihypertensive Medication(s)

    Time frame: 8 weeks

    Use of antihypertensive medication at 8 weeks

  9. 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

  10. 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

  11. 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. Mean Daytime Ambulatory Diastolic Blood Pressure

    Time frame: 8 weeks

    Change from Baseline in Mean Daytime Ambulatory Diastolic Blood Pressure to 8 Weeks

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. Change in Mean Office SBP at 6 Months

    Time frame: 6 months

    Change from Baseline in mean office SBP to 6 Months

  22. Change in Mean Office SBP to 12 Months

    Time frame: 12 months

    Change from Baseline in mean office SBP to 12 Months

  23. Change in Mean Office DBP to 8 Weeks

    Time frame: 8 weeks

    Change from Baseline in mean office DBP to 8 Weeks

  24. Change in Mean Office DBP to 6 Months

    Time frame: 6 months

    Change from Baseline in mean office DBP to 6 Months

  25. Change in Mean Office DBP at 12 Months

    Time frame: 12 months

    Change from Baseline in mean office DBP to 12 Months

Sponsors and collaborators

Lead sponsor

Ablative Solutions, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2024
First posted
Apr 20, 2018
Registry last updated
May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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