ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    Target BP OFF-MED
Previous Study | Return to List | Next Study

The TARGET BP OFF-MED Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03503773
Recruitment Status : Not yet recruiting
First Posted : April 20, 2018
Last Update Posted : October 5, 2018
Sponsor:
Information provided by (Responsible Party):
Ablative Solutions, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Hypertension Hypertension,Essential Drug: Alcohol Other: Sham control Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Outcomes Assessor)
Masking Description: Blinded (The subject, sponsor, and hypertensionist/nephrologist performing the screening and follow-up assessments are blinded. The interventionalist and cath lab staff are unblinded.)
Primary Purpose: Treatment
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
Estimated Study Start Date : October 24, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment Arm:
Renal denervation (using the Peregrine Kit) performed with alcohol infused through the Peregrine Catheter
Drug: Alcohol
Alcohol is directly infused/delivered to the adventitial and periadventitial space of the renal arteries

Sham Comparator: Sham Control Arm
Only renal angiography performed
Other: Sham control
endovascular, renal angiography




Primary Outcome Measures :
  1. Changes in Systolic Ambulatory Blood Pressure [ Time Frame: Baseline to 8 weeks post-treatment ]
    Change in mean 24-hour ambulatory SBP


Secondary Outcome Measures :
  1. Changes in Ambulatory Blood Pressure [ Time Frame: Baseline, and 8 weeks, 6 months, 12 months post treatment ]
    Change in mean 24-hour, daytime, and nighttime ambulatory SBP and DBP

  2. Changes in Office Blood Pressure [ Time Frame: Baseline, and 4 weeks, 8 weeks, 3 months, 6 months, 1 year and 2 years post treatment ]
    Change in mean office SBP and DBP

  3. Responders to target Blood Pressure [ Time Frame: Baseline, and 4 weeks, 8 weeks, 3 months, 6 months, 1 year and 2 years post treatment ]
    Percentage of subjects controlled to target blood pressure values



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to be eligible and undergo the procedure:

  1. Subject has provided written informed consent.
  2. Male or female subject, aged ≥18 and ≤80 years at time of enrollment.
  3. If subject is currently taking no (0) antihypertensive medications, he/she must:

    • Have 3 office blood pressure measurements with a mean office SBP of ≥140 mmHg and ≤180 mmHg AND mean office DBP ≥90 mmHg, and
    • Be willing to adhere to the no-medication regimen for at least 12 weeks (4 week run-in period and 8 week post treatment period).
  4. If subject is currently taking 1 or 2 antihypertensive medications, he/she must:

    • Have 3 office blood pressure measurements with a mean office SBP of ≤180 mmHg AND mean office DBP ≥90 mmHg, and
    • Be willing to discontinue his/her antihypertensive medication(s), and to adhere to the no medication regimen for at least 12 weeks (4 week run-in period and 8 week post treatment period).
  5. Investigator judges that the subject can be discontinued safely from all current antihypertensive medication (where applicable) and managed safely for at least 12 weeks (4 week run-in period and 8 week post treatment period) without antihypertensive medication intake.
  6. Female subjects of childbearing potential must agree to use acceptable methods of contraception (as defined in Section 5.3), from the time of informed consent through to the last follow-up visit.
  7. Subject agrees to have all study procedures performed and is able and willing to comply with all study follow-up visits and protocol requirements.
  8. Subject has 3 office blood pressure measurements with a mean office SBP of ≥140 mmHg and ≤180 mmHg AND mean office DBP ≥90 mmHg.
  9. Subject has a mean 24-hour ambulatory SBP of ≥135 mmHg and ≤170 mmHg

Exclusion Criteria:

  1. Subject has a contraindication known for conventional percutaneous interventional procedures.
  2. Subject has an acute or sub-acute infection that the investigator judges would pose unacceptable procedural risks to the subject.
  3. Subject has imaging-assessed renal artery anatomy abnormalities or variations based on investigator's evaluation of the screening images (i.e. MRA/CTA examination and/or renal angiography) meeting one of the following criteria:

    • Main renal artery that has a diameter of <4 mm or >7 mm and length of <5 mm
    • Accessory renal arteries with diameter >2 mm or <4 mm, which supply >20% of the whole kidney parenchyma on that side, per the investigator's judgment. Note: subjects with more than one eligible accessory renal artery per side will be excluded.
    • Renal artery stenosis >50% of the normal diameter segment (diameter stenosis, compared to the angiographically normal proximal or distal segment)
    • Any renal artery abnormality or disease that, per the physician assessment, precludes the safe insertion of the guiding catheter (including, but not limited to, severe renal artery aneurysm, excessive tortuosity, severe renal artery calcification)
    • Previous renal angioplasty associated with stenting or other implants, that, per the physician's assessment, precludes the safe deployment of the Peregrine Catheter components in the target treatment segment of the renal artery
    • Previous renal denervation
    • Fibromuscular dysplasia of the renal arteries.
  4. Subject has documented severe untreated obstructive sleep apnea (apnea-hypopnea index [AHI] ≥30 per hour).
  5. Subject has documented diagnosis of the following causes of hypertension: Cushing's disease or Cushing's Syndrome, hyperaldosteronism, pheochromocytoma, thyroid and parathyroid abnormalities, or onset of hypertension prior to the age of 18.

7. Subject has orthostatic hypotension at baseline, or documented history of orthostatic hypotension within 12 months prior to the planned procedure, defined as a drop in blood pressure that is >20 mmHg in SBP and/or >10 mmHg in DBP within 3 minutes upon standing from sitting or from a lying down face-up (supine) position.

8. Subject has Type 1 diabetes mellitus. 9. Subject has an 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.

10. Subject has nephrotic syndrome. 12. Subject has a history of nephrectomy, a single kidney or kidney tumor, or urinary tract obstruction (with potential for hydronephrosis). Note: Simple renal cysts are not an exclusion.

13. Subject has a renal transplant, or is known to have a non-functioning kidney or unequal renal size 14. Subject has a history of myocardial infarction, unstable angina pectoris, or stroke/TIA within 6 months prior to the planned procedure.

15. 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).

20. Subject has any other 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.

22. If female, subject is pregnant or lactating at the time of enrollment or planning to become pregnant during the trial time period.

23. Subject has participated in another clinical study involving an investigational drug or investigational device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an investigational drug or investigational device during the course of this study. Subjects enrolled in observational registries not involving renal denervation may still be eligible.


Responsible Party: Ablative Solutions, Inc.
ClinicalTrials.gov Identifier: NCT03503773     History of Changes
Other Study ID Numbers: CR0014
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: October 5, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ablative Solutions, Inc.:
Renal Denervation
Neurolysis

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