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TARGET BP I Clinical Trial (TARGET BP I)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2016 by Ablative Solutions, Inc.
Sponsor:
Information provided by (Responsible Party):
Ablative Solutions, Inc.
ClinicalTrials.gov Identifier:
NCT02910414
First received: September 16, 2016
Last updated: September 20, 2016
Last verified: September 2016
  Purpose
The TARGET BP I Trial is a randomized, double-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 2:1 fashion to treatment versus sham control via central randomization.

Condition Intervention Phase
Hypertension
Drug: Dehydrated alcohol
Device: Peregrine System Kit (Sham Procedure)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: TARGET BP I Trial: A Phase 2, Multicenter, Double-Blinded, Sham-Procedure Controlled Trial of Renal Denervation by the Peregrine System™ Kit, in Subjects With Hypertension

Further study details as provided by Ablative Solutions, Inc.:

Primary Outcome Measures:
  • Change in mean systolic ABPM [ Time Frame: 8 weeks ]
    The change in 24-hour mean systolic ambulatory blood pressure (ABPM) from baseline to 8 weeks


Secondary Outcome Measures:
  • Major Adverse Events [ Time Frame: 30 days ]
    Major Adverse Events as defined in the clinical protocol

  • Decrease in eGFR > 25% [ Time Frame: 8 weeks ]
    Decrease in eGFR > 25% at 8 weeks

  • Changes in eGFR [ Time Frame: 8 weeks and 6 months ]
    Changes in eGFR at 8 weeks and 6 months

  • Adverse event rate [ Time Frame: 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 ]
    Adverse event rate at procedure, discharge, and at all follow-up visits

  • Device success [ Time Frame: Procedure date (day 0) ]
    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

  • Procedure success [ Time Frame: Hospital discharge date (an average of 1 day) ]
    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.

  • Change of office systolic blood pressure [ Time Frame: 8 weeks ]
    Change of office systolic blood pressure from baseline to 8 weeks

  • Change of diastolic office blood pressure [ Time Frame: 8 weeks ]
    Change of diastolic office blood pressure from baseline to 8 weeks

  • Change of 24-hour mean diastolic ABPM [ Time Frame: 8 weeks ]
    Change of 24-hour mean diastolic ABPM from baseline to 8 weeks

  • Changes in antihypertensive regimen [ Time Frame: 8 weeks ]
    Changes in antihypertensive regimen from treatment to 8 weeks

  • Changes in antihypertensive regimen [ Time Frame: 6 months ]
    Changes in antihypertensive regimen from 8 weeks to 6 months

  • ABPM responders (2 mmHg) [ Time Frame: 8 weeks ]
    ABPM Responders, defined as the proportion of subjects with a drop of greater than or equal to 2 mmHg in 24-hour ABPM systolic blood pressure at 8 weeks when compared to baseline

  • Office BP responders (5 mmHg) [ Time Frame: 8 weeks ]
    Office BP Responders, defined as the proportion of subjects with a drop of greater than or equal to 5 mmHg in office-based systolic blood pressure at 8 weeks when compared to baseline

  • ABPM responders (5 mmHg) [ Time Frame: 8 weeks ]
    ABPM Responders, defined as the proportion of subjects with a drop of greater than or equal to 5 mmHg in 24-hour ABPM systolic blood pressure at 8 weeks when compared to baseline

  • Office BP responders (10 mmHg) [ Time Frame: 8 weeks ]
    Office BP Responders, defined as the proportion of subjects with a drop of greater than or equal to 10 mmHg in office-based systolic blood pressure at 8 weeks when compared to baseline


Estimated Enrollment: 100
Study Start Date: October 2016
Estimated Study Completion Date: October 2020
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treated with Peregrine System Kit
The 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.
Drug: Dehydrated alcohol
Dehydrated Alcohol Injection, USP is used in the study.
Other Name: Ethanol
Sham Comparator: Peregrine System Kit (Sham Procedure)
The sham control group will have a percutaneous procedure in which the Peregrine Catheter is delivered to the renal artery, but the needles will not be deployed and no alcohol will be delivered to the perivascular space of the renal arteries.
Device: Peregrine System Kit (Sham Procedure)
The Peregrine Catheter is delivered to the renal arteries, but the needles are not deployed and no alcohol is delivered to the perivascular space.

Detailed Description:

The TARGET BP I Trial is a randomized, double-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 2:1 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject is > 18 and ≤ 75 years old at time of enrollment.
  2. Subjects has maintained their anti-hypertension medication regimen of 2-5 medications (labelled for hypertension) for at least four weeks (28 days) prior to randomization. Two of the anti-hypertensive medications must be at least at 50% of their maximally labelled dose prior to the planned renal denervation treatment. In subjects on two medications, at least one must be a diuretic and the second an ACE inhibitor or angiotensin receptor blocker (ARB). All subjects must currently be on, or have documentation that they failed or cannot tolerated a diuretic. For patient on two non-diuretic antihypertensive medications because they either failed or have been unable to tolerate a diuretic, the two medications must consist of an ACE or ARB and a Calcium Channel blocker (CCB).

    Note: the following classes of antihypertensive agents that would count towards the minimum number of agents are: ACE inhibitors, ARB, calcium channel blockers, thiazide diuretics, loop diuretics, aldosterone antagonists, beta-blockers, centrally active agents, alpha receptor blockers, direct vasodilators, direct renin inhibitors, and hydralazine.

  3. Patient agrees to have all trial procedures performed, to comply with medication regimen and is able and willing to comply with all follow-up visits.
  4. Patient is willing to provide written informed consent.
  5. Meets blood pressure criteria once the four week stable medication monitoring phase has been completed, and prior to the procedure:

    1. Mean of 3 measurements of office systolic Blood Pressure ≥ 150 mmHg and ≤ 180 mmHg, AND
    2. Daytime mean systolic Ambulatory Blood Pressure Measurement (ABPM) ≥ 140 mmHg and ≤ 170 mmHg.
  6. Investigator judges that the subject can be managed safely for up to 12 weeks (4 weeks pre-treatment plus 8 weeks post-treatment) without any changes to their current antihypertensive treatment regimen.

Exclusion Criteria:

  1. Patients with chronic atrial fibrillation.
  2. Patient with documented secondary hypertension, including but not limited to: Cushing's disease or Cushing's Syndrome, hyperaldosteronism, pheochromocytoma, documented obstructive sleep apnea, documented thyroid and parathyroid abnormalities etc., or onset of hypertension prior to the age of 18.

    Note: documented evaluation of secondary hypertension is required.

  3. Renal artery stenosis ≥ 50% diameter stenosis, or aneurysm(s)
  4. History of previous stenting or balloon angioplasty of the renal arteries
  5. History of pre-eclampsia
  6. Orthostatic hypotension at baseline, or documented history of orthostatic hypotension within the last 12 months, defined as a drop in blood pressure that is greater than 20 mmHg in systolic BP and/or more than 10 mmHg in diastolic BP within 3 minutes upon standing from sitting or from a lying down face-up (supine) position
  7. Renal artery anatomy as assessed by imaging (CTA or, MRA or renal angiogram) meeting the following criteria:

    1. Main renal artery that has a diameter of < 4 mm or > 7 mm or a length of < 11 mm (Note: patients with more than one main eligible renal artery per side will be excluded),
    2. Accessory renal arteries with diameter > 2 mm,
    3. Excessive renal artery tortuosity based on Investigator judgment,
    4. Moderate or severe, and diffuse renal artery calcification,
    5. Renal anatomic vascular abnormalities (as assessed by renal imaging) that would increase the risk of renal catheterization, and/or
    6. Fibromuscular dysplasia
  8. Occlusive peripheral vascular disease that would preclude percutaneous access for the procedure.
  9. Patient is known to have a unilateral non-functioning kidney or unequal renal size (> 2 cm difference in renal length between kidneys).
  10. Single kidney, kidney tumor, urinary tract obstruction, or other anatomic abnormality. Note: Simple renal cysts are not an exclusion.
  11. Previous renal denervation.
  12. History of renal transplantation.
  13. History of pyelonephritis within 6 months.
  14. History of recurrent (> one episode) kidney stones, or history of kidney stones within the last year.
  15. Estimated eGFR (by the CKD-Epi formula) < 45 mL/min per 1.73 m2, or on chronic renal replacement therapy.
  16. Unexplained hypokalemia (i.e. K < 3.5 mEq/L in subjects not on a potassium-wasting diuretic).

    Note: Patients with hypokalemia who are not on a potassium-wasting diuretic but have another potential reason for hypokalemia should be discussed with the Medical Monitor.

    Note: Hypokalemia, with known etiology (i.e. diuretic effect), should be corrected before proceeding with the procedure.

  17. Patient in whom an ABPM device cannot be used due to arm size (> 40 cm arm circumference) or other reasons as identified by the Investigator or study coordinator.
  18. Patient with severe cardiac valve stenosis for which, in the opinion of the Investigator, a significant reduction of blood pressure is contraindicated.
  19. Patient has heart failure (NYHA Class II to IV) or has an ejection fraction ≤ 35%.
  20. Known primary or secondary pulmonary hypertension.
  21. Active infection.
  22. Type 1 diabetes mellitus.
  23. Patient requiring chronic oxygen support or has severe COPD.
  24. Patient has known hypersensitivity to contrast agents that cannot be adequately pre-medicated
  25. A known hypersensitivity to Dehydrated Alcohol Injection, USP.
  26. Platelet count < 75,000/microliter and/or known bleeding diathesis or coagulopathy at time of screening.
  27. Receiving anticoagulant drugs (e.g., warfarin, dabigatran, rivaroxaban, apixaban, edoxaban, or low molecular weight heparins), that in the opinion of the Investigator, would affect the safety of the trial procedure. Use of antiplatelet drugs such as aspirin and/or thienopyridines (e.g., clopidogrel) are permitted.
  28. Patient has current problems with substance abuse (e.g. alcohol, illegal drugs, etc.).
  29. Patient on steroids at immunosuppressant doses, or immunosuppressant therapy, except for nasal and pulmonary inhalants.
  30. Patient has a history of myocardial infarction, unstable angina pectoris, or stroke during the 6 months prior to enrollment.
  31. Pregnant or nursing or planning to become pregnant during the trial time period.

    Note: If subject is of childbearing potential, as defined in the protocol, agrees to use of contraception.

  32. Any acute or chronic condition that the investigator believes will adversely affect the ability to interpret the data or will prevent the subject from completing the trial procedures, or has a life expectancy of < 12 months.
  33. Patient is participating or does not agree to not participate in any other investigational drug or device trial until their participation in this study is completed.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02910414

Contacts
Contact: Nicole Haratani nharatani@ablativesolutions.com
Contact: Ali Kakavand akakavand@ablativesolutions.com

Sponsors and Collaborators
Ablative Solutions, Inc.
Investigators
Principal Investigator: David Kandzari, MD Piedmont Heart Institute
Principal Investigator: Michael Weber, MD SUNY Downstate Medical
Principal Investigator: Atul Pathak, MD Clinique Pasteur
Principal Investigator: Felix Mahfoud, MD Klinik fur Innere Medizin III
  More Information

Responsible Party: Ablative Solutions, Inc.
ClinicalTrials.gov Identifier: NCT02910414     History of Changes
Other Study ID Numbers: CR0002
Study First Received: September 16, 2016
Last Updated: September 20, 2016
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 28, 2017