Phase 2
Completed N=106
The TARGET BP OFF-MED Trial
Hypertension · Hypertension,Essential
Source: ClinicalTrials.gov NCT03503773 ↗
Enrolled (actual)
106
Serious AEs
15.1%
Results posted
Oct 2024
Primary outcomePrimary: Changes in Systolic Ambulatory Blood Pressure — -1.4; -2.9 mmHg — p=0.2682
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Systolic Ambulatory Blood Pressure |
-1.4; -2.9 | 0.2682 |
| SECONDARY Change in Mean 24-Hour Ambulatory Systolic Blood Pressure at 6 Months |
135.1; 134.1; -13.4; -13.9 | 0.6964 |
| SECONDARY Change in Mean 24-Hour Ambulatory Systolic Blood Pressure at 12 Months |
133.7; 137.6; -15.9; -10.6 | 0.0775 |
| SECONDARY Change in Office SBP at 8 Weeks |
160.6; 155.4; 0.63; -4.0 | — |
| SECONDARY Change in Mean 24-Hour Ambulatory Diastolic Blood Pressure at 8 Weeks |
91.0; 92.2; -1.1; -2.0 | 0.4734 |
| SECONDARY Change in Mean 24-Hour Ambulatory Diastolic Blood Pressure at 6 Months |
83.4; 83.0; -8.0; -9.3 | — |
| SECONDARY Change in Mean 24-Hour Ambulatory Diastolic Blood Pressure at 12 Months |
81.0; 85.6; -9.8; -7.3 | 0.0341 sig |
| SECONDARY Number of Participants With Major Adverse Events (MAEs) |
1; 1 | — |
| SECONDARY Use of Antihypertensive Medication(s) |
0.089; 0.060 | 0.573 |
| SECONDARY Change in Mean Daytime Ambulatory Systolic Blood Pressure at 8 Weeks |
153.2; 150.6; -1.7; -3.2 | — |
| SECONDARY Change in Mean Daytime Ambulatory Systolic Blood Pressure at 6 Months |
140.6; 139.7; -14.5; -14.0 | — |
| SECONDARY Change in Mean Daytime Ambulatory Systolic Blood Pressure at 12 Months |
140.1; 143.5; -15.5; -10.5 | — |
| SECONDARY Mean Daytime Ambulatory Diastolic Blood Pressure |
94.7; 95.2; -1.4; -2.3 | — |
| SECONDARY Change in Mean Daytime Ambulatory Diastolic Blood Pressure at 6 Months |
87.6; 87.8; -8.9; -9.3 | — |
| SECONDARY Change in Mean Daytime Ambulatory Diastolic Blood Pressure at 12 Months |
86.0; 90.4; -9.5; -7.6 | — |
| SECONDARY Change in Mean Nighttime Ambulatory Systolic Blood Pressure at 8 Weeks |
136.9; 134.4; -0.58; -3.3 | — |
| SECONDARY Change in Mean Nighttime Ambulatory Systolic Blood Pressure at 6 Months |
125.6; 125.4; -12.8; -13.4 | — |
| SECONDARY Change in Mean Nighttime Ambulatory Systolic Blood Pressure to 12 Months |
123.1; 127.8; -17.1; -11.8 | — |
| SECONDARY Change in Mean Nighttime Ambulatory Diastolic Blood Pressure at 8 Weeks |
82.5; 81.5; -0.44; -2.5 | — |
| SECONDARY Change in Mean Nighttime Ambulatory Diastolic Blood Pressure at 6 Months |
75.8; 75.5; -7.4; -9.0 | — |
| SECONDARY Change in Mean Nighttime Ambulatory Diastolic Blood Pressure at 12 Months |
72.8; 77.4; -10.8; -7.6 | — |
| SECONDARY Change in Mean Office SBP at 6 Months |
145.7; 146.1; -14.7; -12.9 | — |
| SECONDARY Change in Mean Office SBP to 12 Months |
147.8; 147.9; -13.2; -11.0 | — |
| SECONDARY Change in Mean Office DBP to 8 Weeks |
97.3; 97.0; -1.1; -3.5 | — |
| SECONDARY Change in Mean Office DBP to 6 Months |
89.7; 90.4; -8.4; -10.0 | — |
| SECONDARY Change in Mean Office DBP at 12 Months |
88.5; 91.0; -9.6; -9.4 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
- Subject is willing to discontinue any current antihypertensive medications during the run-in period and the post-treatment period.
- Has a mean 24-hour ambulatory SBP of ≥135 mmHg and ≤170 mmHg with ≥70% valid readings
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT03503773). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.