Hypertension Clinical 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
Verified date | July 2023 |
Source | Ablative Solutions, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 90 |
Est. completion date | December 2023 |
Est. primary completion date | January 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Belgium | Cliniques Universitaires Saint-Luc | Brussels | |
France | Clinique Pasteur Toulouse | Toulouse | |
Germany | Universitätsklinikum des Saarlandes | Homburg/Saar | |
United Kingdom | NIHR Barts Cardiovascular Biomedical Research Unit | London |
Lead Sponsor | Collaborator |
---|---|
Ablative Solutions, Inc. |
Belgium, France, Germany, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in Systolic Ambulatory Blood Pressure | Change in mean 24-hour ambulatory SBP | Baseline to 8 weeks post-treatment | |
Secondary | Changes in Ambulatory Blood Pressure | Change in mean 24-hour, daytime, and nighttime ambulatory SBP and DBP | Baseline, and 8 weeks, 6 months, 12 months post treatment | |
Secondary | Changes in Office Blood Pressure | Change in mean office SBP and DBP | Baseline, and 4 weeks, 8 weeks, 3 months, 6 months, 1 year and 2 years post treatment | |
Secondary | Use of antihypertensive medication(s) | Evaluate differences between groups | 8 weeks, 6 months,1 year post treatment | |
Secondary | Evaluation of safety | Major adverse events (MAEs) | 30 days post procedure |
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