TARGET BP I Clinical Trial (TARGET BP I)
- Study HIC#:2000025879
- Last Updated:07/15/2021
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
- Age18 years - 80 years
- Start Date10/30/2019
- End Date12/30/2021
Trial Purpose and 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.
1.Subject has provided written informed consent.
2.Male or female subject, aged ≥18 and ≤80 years at time of enrollment.
3.Subject is taking 2-5 antihypertensive medications (labeled for hypertension) at time of enrollment, and is willing to adhere to a stable (no change) medication regimen during the 4-week run-in period and the 3 months post-procedure. Antihypertensive medications must be as follows:
Two of the antihypertensive medications must be at least at 50% of their maximally labelled dose prior to the planned procedure.
In subjects on 2 medications, at least one must be a diuretic and the second an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB).
In the case of the thiazide agents hydrochlorothiazide and chlorthalidone, such doses should be 25 mg daily, reflecting the usual maximum doses in contemporary medical practice when these diuretic agents are used in combination treatment.
All subjects must currently be taking, or have documentation that they failed or cannot tolerate, a diuretic.
For subjects on 2 non-diuretic antihypertensive medications, because they either failed or have been unable to tolerate a diuretic, the 2 medications must consist of an ACE inhibitor 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, ARBs, calcium channel blockers, thiazide diuretics, loop diuretics, aldosterone antagonists, beta-blockers, centrally active agents, alpha receptor blockers, direct vasodilators, direct renin inhibitors, and hydralazine.
4.Subject meets blood pressure criteria at time of enrollment and prior to the 4-week run-in period:
Has 3 office blood pressure measurements with a mean office SBP of ≥150 mmHg and ≤180 mmHg, AND a mean office diastolic blood pressure (DBP) ≥90 mmHg
5.Investigator judges that the subject can be managed safely during the 4-week run-in period and 3 months post-procedure period without any changes to their current antihypertensive medication regimen.
End of run-in period
6.Subject has maintained the same antihypertensive medication regimen for at least 4 weeks (28 days) prior to the procedure.
7.Subject meets blood pressure criteria:
Has 3 office blood pressure measurements with a mean office SBP of ≥150 mmHg and ≤180 mmHg AND mean office DBP ≥90 mmHg AND Has a mean 24-hour ambulatory SBP of ≥135 mmHg and ≤170 mmHg with ≥70% valid readings (as determined by ABPM measurement device).
1.Subject has documented severe untreated obstructive sleep apnea (apnea-hypopnea index [AHI] ≥30 per hour).
2.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.
3.Subject has a history of pre-eclampsia.
4.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.
5.Any contraindication to the imaging as required per the protocol.
6.Subject has imaging-assessed renal artery anatomy abnormalities or variations based on investigator's evaluation of the screening images (i.e. magnetic resonance angiography (MRA)/computed tomography angiography (CTA) examination) 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.
7.Subject has a renal transplant, or is known to have a non-functioning kidney or unequal renal size (>2 cm difference in renal length between kidneys associated with a chronic kidney disease or a deterioration of the kidney function).
8.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.
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 for whom an ABPM device cannot be used due to arm size (>42 cm arm circumference) or other reasons as identified by the investigator.
11.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).
12.Subject has an acute or sub-acute infection that the investigator judges would pose unacceptable procedural risks to the subject.
13.Subject has Type 1 diabetes mellitus, or uncontrolled Type 2 diabetes mellitus (defined as hemoglobin A1c [HbA1c] ≥9.0%).
14.Subject has a contraindication known for conventional percutaneous interventional procedures such as:
◦Intolerance for antiplatelet/anticoagulant therapy
◦Known hypersensitivity to contrast media that cannot be adequately pre-medicated
◦Bleeding disorders (such as bleeding diathesis, thrombocytopenia, and severe anemia)
◦Occlusive peripheral vascular disease that would preclude percutaneous femoral access for the procedure.
15.Subject has a known hypersensitivity to the neurolytic agent (i.e. dehydrated alcohol).
16.Subject has a history of myocardial infarction, unstable angina pectoris, or stroke/transient ischemic attack (TIA) within 6 months prior to the planned procedure.