Clinical trial NCT03503773: The TARGET BP OFF-MED Trial
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypertension
Hypertension,Essential
Keywords: Renal Denervation
Neurolysis
Lead sponsor: Ablative Solutions, Inc.
Sponsor class: INDUSTRY
First posted: 2018-04-20
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Changes in Systolic Ambulatory Blood Pressure
timeFrame: Baseline to 8 weeks post-treatment
Secondary outcomes:
measure: Change in Mean 24-Hour Ambulatory Systolic Blood Pressure at 6 Months
timeFrame: 6 months
measure: Change in Mean 24-Hour Ambulatory Systolic Blood Pressure at 12 Months
timeFrame: 12 months
measure: Change in Office SBP at 8 Weeks
timeFrame: 8 weeks
measure: Change in Mean 24-Hour Ambulatory Diastolic Blood Pressure at 8 Weeks
timeFrame: 8 weeks
measure: Change in Mean 24-Hour Ambulatory Diastolic Blood Pressure at 6 Months
timeFrame: 6 months
measure: Change in Mean 24-Hour Ambulatory Diastolic Blood Pressure at 12 Months
timeFrame: 12 months
measure: Number of Participants With Major Adverse Events (MAEs)
timeFrame: 30 days post procedure
measure: Use of Antihypertensive Medication(s)
timeFrame: 8 weeks
measure: Change in Mean Daytime Ambulatory Systolic Blood Pressure at 8 Weeks
timeFrame: 8 weeks
measure: Change in Mean Daytime Ambulatory Systolic Blood Pressure at 6 Months
timeFrame: 6 months
measure: Change in Mean Daytime Ambulatory Systolic Blood Pressure at 12 Months
timeFrame: 12 months
measure: Mean Daytime Ambulatory Diastolic Blood Pressure
timeFrame: 8 weeks
measure: Change in Mean Daytime Ambulatory Diastolic Blood Pressure at 6 Months
timeFrame: 6 months
measure: Change in Mean Daytime Ambulatory Diastolic Blood Pressure at 12 Months
timeFrame: 12 months
measure: Change in Mean Nighttime Ambulatory Systolic Blood Pressure at 8 Weeks
timeFrame: 8 weeks
measure: Change in Mean Nighttime Ambulatory Systolic Blood Pressure at 6 Months
timeFrame: 6 months
measure: Change in Mean Nighttime Ambulatory Systolic Blood Pressure to 12 Months
timeFrame: 12 months
measure: Change in Mean Nighttime Ambulatory Diastolic Blood Pressure at 8 Weeks
timeFrame: 8 weeks
measure: Change in Mean Nighttime Ambulatory Diastolic Blood Pressure at 6 Months
timeFrame: 6 months
measure: Change in Mean Nighttime Ambulatory Diastolic Blood Pressure at 12 Months
timeFrame: 12 months
measure: Change in Mean Office SBP at 6 Months
timeFrame: 6 months
measure: Change in Mean Office SBP to 12 Months
timeFrame: 12 months
measure: Change in Mean Office DBP to 8 Weeks
timeFrame: 8 weeks
measure: Change in Mean Office DBP to 6 Months
timeFrame: 6 months
measure: Change in Mean Office DBP at 12 Months
timeFrame: 12 months
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Toulouse
country: France
facility: Clinique Pasteur Toulouse
city: Homburg/Saar
country: Germany
facility: Universitätsklinikum des Saarlandes
city: London
country: United Kingdom
facility: NIHR Barts Cardiovascular Biomedical Research Unit
Study officials:
affiliation: Universitätsklinikum des Saarlandes Klinik für Innere Medizin III Kardiologie, Angiologie und Internistische Intensivmedizin, Germany
name: Felix Mahfoud, Prof.Dr.med.
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinique Pasteur Hi-LAB, Toulouse, France
name: Atul Pathak, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pathak A, Rudolph UM, Saxena M, Zeller T, Muller-Ehmsen J, Lipsic E, Schmieder RE, Sievert H, Halbach M, Sharif F, Parise H, Fischell TA, Weber MA, Kandzari DE, Mahfoud F. Alcohol-mediated renal denervation in patients with hypertension in the absence of antihypertensive medications. EuroIntervention. 2023 Sep 18;19(7):602-611. doi: 10.4244/EIJ-D-23-00088.
citation: Bertog S, Sharma A, Mahfoud F, Pathak A, Schmieder RE, Sievert K, Papademetriou V, Weber MA, Haratani N, Lobo MD, Saxena M, Kandzari DE, Fischell TA, Sievert H. Alcohol-Mediated Renal Sympathetic Neurolysis for the Treatment of Hypertension: The Peregrine Infusion Catheter. Cardiovasc Revasc Med. 2021 Mar;24:77-86. doi: 10.1016/j.carrev.2020.09.003. Epub 2020 Sep 7.