The TARGET BP OFF-MED Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03503773
• Other study ID #: CR0014
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: September 24, 2018
• Est. completion date: December 2023

Study information

• Verified date: July 2023
• Source: Ablative Solutions, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension
• Hypertension,Essential

Intervention

Drug:
• Alcohol
Alcohol is directly infused/delivered to the adventitial and periadventitial space of the renal arteries

Other:
• Sham control
endovascular, renal angiography

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Ablative Solutions, Inc.

Countries where clinical trial is conducted

Belgium,  France,  Germany,  United Kingdom, 

Outcome

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