The TARGET BP OFF-MED Trial

Ablative Solutions

Status and phase: Completed; Phase 2

Conditions: Hypertension,Essential; Hypertension

Treatments: Other: Sham control; Drug: Alcohol

Study type: Interventional

Funder types: Industry

Identifiers

NCT03503773

CR0014

Details and patient eligibility

About

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.

Enrollment: 350 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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.
2. Subject is willing to discontinue any current antihypertensive medications during the run-in period and the post-treatment period.
3. Has a mean 24-hour ambulatory SBP of ≥135 mmHg and ≤170 mmHg with ≥70% valid readings

Exclusion criteria

1. Subject has renal artery anatomy abnormalities.
2. 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.
3. Subject has documented sleep apnea.
4. 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).
5. Subject is pregnant or lactating at the time of enrollment or planning to become pregnant during the trial time period (female subjects only).
6. 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.
7. Subject has a history of myocardial infarction, unstable angina pectoris, or stroke/TIA within 6 months prior to the planned procedure.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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350 participants in 2 patient groups

Treatment Arm:

Experimental group

Description:

Renal denervation (using the Peregrine Kit) performed with alcohol infused through the Peregrine Catheter

Treatment:

Drug: Alcohol

Sham Control Arm

Sham Comparator group

Description:

Only renal angiography performed

Treatment:

Other: Sham control