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HypertensionPhase 3TARGET BP INCT02910414

TARGET BP I Clinical Trial

A Phase 3 study testing Dehydrated alcohol in people with Hypertension, run by Ablative Solutions, Inc. at 5 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The TARGET BP I Trial is a randomized, blinded, multi-center, international, sham-procedure controlled trial, comparing renal denervation performed with the Peregrine System Kit in the treatment group to the sham control group (without renal denervation - no alcohol infusion). Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Hypertension
What is being tested?
Dehydrated alcohol
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
300 participants
Where
5 sitesUnited States
Study dates
22 Jul 2019to May 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 ≥150 mmHg and ≤180 mmHg, AND a mean office diastolic blood pressure (DBP) of ≥90 mmHg when receiving 2 to 5 antihypertensive medications.
  • 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

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Piedmont Heart Institute

    Atlanta, Georgia, 30309

  • Cardiology PC

    Birmingham, Alabama, 35211

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

  • NC Heart and Vascular Research

    Raleigh, North Carolina, 27607

  • Wake Forest University Baptist Medical Center

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: A Pivotal, Multicenter, Blinded, Sham Procedure-Controlled Trial of Renal Denervation by the Peregrine System™ Kit, in Subjects With Hypertension

The TARGET BP I Trial is a randomized, blinded, multi-center, international, sham-procedure controlled trial, comparing renal denervation performed with the Peregrine System Kit in the treatment group to the sham control group (without renal denervation - no alcohol infusion). Subjects will be randomized in a 1:1 fashion to treatment versus sham control via central randomization.

Read the detailed description

The TARGET BP I Trial is a randomized, blinded, multi-center, international, sham-procedure controlled trial, comparing renal denervation performed with the Peregrine System Kit in the treatment group to the sham control group (without renal denervation - no alcohol infusion). Subjects will be randomized in a 1:1 fashion to treatment versus sham control via central randomization.

The TARGET BP I clinical trial uses a percutaneous catheter to deliver very small amounts of alcohol (neurolytic agent). The patient population for this trial is comparable to those used in other renal denervation studies, but also incorporates lessons learned from recent trials of renal denervation. This is to enable the study of an optimized patient population who stands to benefit from the intervention, in a manner that reduces possible study bias.

This trial is intended to evaluate the safety and efficacy of the Peregrine Catheter when used to deliver a 0.6 mL volume of alcohol to the perivascular area of the respective renal arteries while patients are adequately managed with oral antihypertensive medications.

Conditions
Hypertension
Being tested
Dehydrated alcohol, Peregrine System Kit (Sham Procedure)
Keywords
Renal Denervation, Alcohol
Medical subject headings
Hypertension

What participants receive

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

  • Dehydrated alcoholDrug

    Also called Ethanol

    Dehydrated Alcohol Injection, USP is used in the study.

  • Peregrine System Kit (Sham Procedure)Device

    Pre-procedural diagnostic renal angiography only, performed for confirmation of anatomical eligibility prior to randomization

Study groups in NCT02910414
Study groupRoleWhat they receive
Treated with Peregrine System KitExperimentalThe experimental group will receive an infusion of Dehydrated Alcohol Injection, USP into the perivascular space of the renal arteries with the Peregrine Catheter. A total of 0.6mL of the alcohol will be delivered to the perivascular space of each renal artery. The drug will only be delivered once to each renal artery during the treatment procedure.
Receives: Drug: Dehydrated alcohol
Renal Angiography Only (Sham Procedure)Sham comparatorThe sham control group will only have diagnostic renal angiography performed. There will be no insertion of the Peregrine Catheter and no alcohol infusion (i.e. no renal denervation).
Receives: Device: Peregrine System Kit (Sham Procedure)

What is being measured

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

  1. Change in mean systolic ABPM

    The change in mean 24-hour ambulatory SBP from baseline to 3 months post-procedure

    Measured: 3 months

Secondary outcomes (23)

  1. Proportion of subjects with major adverse events

    Major Adverse Events as defined in the clinical protocol

    Measured: 30 days

  2. Major Adverse Events

    Major Adverse Events as defined in the clinical protocol

    Measured: 3, 6, and 12 months and 2 and 3 years

  3. Decrease in eGFR > 25%

    Decrease in eGFR > 25% at 3 and 6 months

    Measured: 3 and 6 months

  4. Changes in eGFR

    Changes in eGFR at 3 and 6 months

    Measured: 3 and 6 months

  5. Adverse event rate

    Adverse event rate at procedure, discharge, and at all follow-up visits

    Measured: Procedure date, discharge date (an average of 1 day), 5-day, 4 weeks, 8 weeks, 3 months, 4 months, 5 months, 6 months, 1 year, 2 years and 3 years

  6. Device success

    Device success, defined as successful introduction of the catheter, navigation to the treatment site, deployment of the needles, and infusion of the alcohol to the intended area via the Peregrine Catheter as intended for use

    Measured: Procedure date (day 0)

  7. Procedure success

    Procedure success defined as device success and freedom from serious adverse events related to the product or the procedure, during the procedure and prior to hospital discharge from the index procedure.

    Measured: Hospital discharge date (an average of 1 day)

  8. Change of office systolic blood pressure

    Change of office systolic blood pressure from baseline to 8 weeks

    Measured: 8 weeks

  9. Change of diastolic office blood pressure

    Change of diastolic office blood pressure from baseline to 3 and 6 months

    Measured: 3 and 6 months

  10. Change of 24-hour mean diastolic ABPM

    Change of 24-hour mean diastolic ABPM from baseline to 3 and 6 months

    Measured: 3 and 6 months

  11. Change of 24-hour mean systolic ABPM

    Change of 24-hour mean systolic ABPM from baseline to 6 months

    Measured: 6 months

  12. Changes in antihypertensive regimen

    Changes in antihypertensive regimen from procedure to 3 months post-procedure

    Measured: 3 months

  13. ABPM responders (5 mmHg)

    ABPM Responders, defined as the proportion of subjects with a drop of ≥5 mmHg in 24-hour ambulatory SBP at 3 months compared with baseline.

    Measured: 3 months

  14. Office BP responders (10 mmHg)

    Office BP Responders, defined as the proportion of subjects with a drop of ≥10 mmHg in office SBP at 3 months compared with baseline.

    Measured: 3 months

  15. Change in mean office SBP

    Change in mean office SBP from baseline to 6 months post-procedure

    Measured: 6 months

  16. Change in mean daytime ambulatory SBP

    Change in mean daytime ambulatory SBP from baseline to 3 months post procedure.

    Measured: 3 months

  17. Change in mean daytime ambulatory SBP

    Change in mean daytime ambulatory SBP from baseline to 6 months post procedure.

    Measured: 6 months

  18. Change in mean daytime ambulatory DBP

    Change in mean daytime ambulatory DBP from baseline to 3 months and then 6 months post procedure.

    Measured: 3 and 6 months

  19. Changes (decreases or increases) in antihypertensive medication regimen from 3 months to 6 months post-procedure

    Changes (decreases or increases) in antihypertensive medication regimen from 3 months to 6 months post-procedure (titrated according to standardized formula to maintain a target office SBP of < 140 mmHg and ≥ 90 mmHg).

    Measured: 3 and 6 months

  20. Changes (decreases or increases) in antihypertensive medication regimen from procedure to 6 months post-procedure

    Changes (decreases or increases) in antihypertensive medication regimen from procedure to 6 months post-procedure (titrated according to standardized formula to maintain a target office SBP of <140 mmHg and ≥90 mmHg)

    Measured: 6 months

  21. Change in mean nighttime ambulatory SBP

    Change in mean nighttime ambulatory SBP from baseline to 3 months and then 6 months post procedure.

    Measured: 3 and 6 months

  22. Change in mean nighttime ambulatory DBP

    Change in mean nighttime ambulatory DBP from baseline to 3 months and then 6 months post procedure.

    Measured: 3 and 6 months

  23. Reduction of office SBP and DBP to normal

    Reduction of office SBP and DBP to normal (<140/90 mmHg) at 3, 6 and 12 months as compared to baseline.

    Measured: 3, 6, and 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 posted22 Sep 2016 (estimated)
  2. Study start22 Jul 2019
  3. Primary completionDec 2023 (estimated)
  4. Study completionMay 2026 (estimated)

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02910414
Sponsor's protocol ID
CR0002
Acronym
TARGET BP I
Status last verified
Oct 2023
First submitted
16 Sep 2016
Last updated
3 Oct 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Kandzari DE, Weber MA, Pathak A, Zidar JP, Saxena M, David SW, Schmieder RE, Janas AJ, Langer C, Persu A, Mendelsohn FO, Ameloot K, Foster M 3rd, Fischell TA, Parise H, Mahfoud F. Effect of Alcohol-Mediated Renal Denervation on Blood Pressure in the Presence of Antihypertensive Medications: Primary Results From the TARGET BP I Randomized Clinical Trial. Circulation. 2024 Jun 11;149(24):1875-1884. doi: 10.1161/CIRCULATIONAHA.124.069291. Epub 2024 Apr 8.

    PubMed 38587557

  • 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 3 study testing Dehydrated alcohol in people with Hypertension, run by Ablative Solutions, Inc. at 5 sites in United States.

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 2 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: under way, not looking for participants, as of the sponsor's last update on 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

Change in mean systolic ABPM (time frame: 3 months). 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 NCT02910414, which also lists 2 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 3 Oct 2023.

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