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HypertensionPhase 2NCT03503773

The TARGET BP OFF-MED Trial

A Phase 2 study testing Alcohol in people with Hypertension and Hypertension,Essential, run by Ablative Solutions, Inc. at 4 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Hypertension, Hypertension,Essential
What is being tested?
Alcohol
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
350 participants
Where
4 sitesin 4 countries
Study dates
24 Sep 2018to 10 Jan 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

4 sites in 4 countries.

4 sites in 4 countries

Belgium1 site

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

Other trials in Belgium

France1 site

  • Clinique Pasteur Toulouse

    Toulouse

Other trials in France

Germany1 site

  • Universitätsklinikum des Saarlandes

    Homburg/Saar, 66421

Other trials in Germany

United Kingdom1 site

  • NIHR Barts Cardiovascular Biomedical Research Unit

    London, EC1M 6BQ

Other trials in United Kingdom

About this study

Official 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

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.

Being tested
Alcohol, Sham control
Keywords
Renal Denervation, Neurolysis
Medical subject headings
Hypertension, Essential Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AlcoholDrug

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

  • Sham controlOther

    endovascular, renal angiography

Study groups in NCT03503773
Study groupRoleWhat they receive
Treatment Arm:ExperimentalRenal denervation (using the Peregrine Kit) performed with alcohol infused through the Peregrine Catheter
Receives: Drug: Alcohol
Sham Control ArmSham comparatorOnly renal angiography performed
Receives: Other: Sham control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in Systolic Ambulatory Blood Pressure

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

    Measured: Baseline to 8 weeks post-treatment

Secondary outcomes (25)

  1. 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

    Measured: 6 months

  2. 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

    Measured: 12 months

  3. Change in Office SBP at 8 Weeks

    Change from Baseline in mean office SBP to Week 8

    Measured: 8 weeks

  4. 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

    Measured: 8 weeks

  5. 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

    Measured: 6 months

  6. 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

    Measured: 12 months

  7. Number of Participants With Major Adverse Events (MAEs)

    Number of participants with major adverse events (MAEs) 30 days post-procedure

    Measured: 30 days post procedure

  8. Use of Antihypertensive Medication(s)

    Use of antihypertensive medication at 8 weeks

    Measured: 8 weeks

  9. Change in Mean Daytime Ambulatory Systolic Blood Pressure at 8 Weeks

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

    Measured: 8 weeks

  10. Change in Mean Daytime Ambulatory Systolic Blood Pressure at 6 Months

    Change from Baseline in Mean Daytime Ambulatory Systolic Blood Pressure to 6 Months

    Measured: 6 months

  11. Change in Mean Daytime Ambulatory Systolic Blood Pressure at 12 Months

    Change from Baseline in Mean Daytime Ambulatory Systolic Blood Pressure to 12 Months

    Measured: 12 months

  12. Mean Daytime Ambulatory Diastolic Blood Pressure

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

    Measured: 8 weeks

  13. Change in Mean Daytime Ambulatory Diastolic Blood Pressure at 6 Months

    Change from Baseline in Mean Daytime Ambulatory Diastolic Blood Pressure to 6 months

    Measured: 6 months

  14. Change in Mean Daytime Ambulatory Diastolic Blood Pressure at 12 Months

    Change from Baseline in Mean Daytime Ambulatory Diastolic Blood Pressure to 12 Months

    Measured: 12 months

  15. Change in Mean Nighttime Ambulatory Systolic Blood Pressure at 8 Weeks

    Change from Baseline in Mean Nighttime Ambulatory Systolic Blood Pressure to 8 Weeks

    Measured: 8 weeks

  16. Change in Mean Nighttime Ambulatory Systolic Blood Pressure at 6 Months

    Change from Baseline in Mean Nighttime Ambulatory Systolic Blood Pressure to 6 Months

    Measured: 6 months

  17. Change in Mean Nighttime Ambulatory Systolic Blood Pressure to 12 Months

    Change from Baseline in Mean Nighttime Ambulatory Systolic Blood Pressure to 12 Months

    Measured: 12 months

  18. Change in Mean Nighttime Ambulatory Diastolic Blood Pressure at 8 Weeks

    Change from Baseline in Mean Nighttime Ambulatory Diastolic Blood Pressure to 8 weeks

    Measured: 8 weeks

  19. Change in Mean Nighttime Ambulatory Diastolic Blood Pressure at 6 Months

    Change from Baseline in Mean Nighttime Ambulatory Diastolic Blood Pressure to 6 Months

    Measured: 6 months

  20. Change in Mean Nighttime Ambulatory Diastolic Blood Pressure at 12 Months

    Change from Baseline in Mean Nighttime Ambulatory Diastolic Blood Pressure to 12 Months

    Measured: 12 months

  21. Change in Mean Office SBP at 6 Months

    Change from Baseline in mean office SBP to 6 Months

    Measured: 6 months

  22. Change in Mean Office SBP to 12 Months

    Change from Baseline in mean office SBP to 12 Months

    Measured: 12 months

  23. Change in Mean Office DBP to 8 Weeks

    Change from Baseline in mean office DBP to 8 Weeks

    Measured: 8 weeks

  24. Change in Mean Office DBP to 6 Months

    Change from Baseline in mean office DBP to 6 Months

    Measured: 6 months

  25. Change in Mean Office DBP at 12 Months

    Change from Baseline in mean office DBP to 12 Months

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2018
  2. Study start24 Sep 2018
  3. Primary completion31 Jan 2022
  4. Study completion10 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
350 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03503773
Sponsor's protocol ID
CR0014
Status last verified
May 2025
First submitted
23 Mar 2018
Last updated
14 May 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 37427416

  • Bytyqi V, Kannenkeril D, Striepe K, Bosch A, Karg MV, Schmid A, Schiffer M, Uder M, Schmieder RE. Predicting blood pressure response to renal denervation based on a new approach. J Hypertens. 2025 Mar 1;43(3):413-419. doi: 10.1097/HJH.0000000000003918. Epub 2024 Oct 29.

    PubMed 39526682

  • 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.

    PubMed 32958438

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Alcohol in people with Hypertension and Hypertension,Essential, run by Ablative Solutions, Inc. at 4 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Belgium, France, Germany, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Systolic Ambulatory Blood Pressure (time frame: Baseline to 8 weeks post-treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03503773, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025; AzTrials last refreshed its copy on 29 Oct 2026.

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