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The TARGET BP OFF-MED Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03503773
Recruitment Status : Recruiting
First Posted : April 20, 2018
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
Ablative Solutions, Inc.

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.

Condition or disease Intervention/treatment Phase
Hypertension Hypertension,Essential Drug: Alcohol Other: Sham control Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Blinded (The subject, sponsor, and hypertensionist/nephrologist performing the screening and follow-up assessments are blinded. The interventionalist and cath lab staff are unblinded.)
Primary Purpose: Treatment
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
Actual Study Start Date : September 24, 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment Arm:
Renal denervation (using the Peregrine Kit) performed with alcohol infused through the Peregrine Catheter
Drug: Alcohol
Alcohol is directly infused/delivered to the adventitial and periadventitial space of the renal arteries

Sham Comparator: Sham Control Arm
Only renal angiography performed
Other: Sham control
endovascular, renal angiography




Primary Outcome Measures :
  1. Changes in Systolic Ambulatory Blood Pressure [ Time Frame: Baseline to 8 weeks post-treatment ]
    Change in mean 24-hour ambulatory SBP


Secondary Outcome Measures :
  1. Changes in Ambulatory Blood Pressure [ Time Frame: Baseline, and 8 weeks, 6 months, 12 months post treatment ]
    Change in mean 24-hour, daytime, and nighttime ambulatory SBP and DBP

  2. Changes in Office Blood Pressure [ Time Frame: Baseline, and 4 weeks, 8 weeks, 3 months, 6 months, 1 year and 2 years post treatment ]
    Change in mean office SBP and DBP

  3. Responders to target Blood Pressure [ Time Frame: Baseline, and 4 weeks, 8 weeks, 3 months, 6 months, 1 year and 2 years post treatment ]
    Percentage of subjects controlled to target blood pressure values



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Has 3 office blood pressure measurements with a mean office systolic blood pressure (SBP) of ≥150 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03503773


Contacts
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Contact: Deborah Schmalz +1 (650) 688-9743 dschmalz@ablativesolutions.com
Contact: Debbie Reynolds, PhD +1 (650) 688-9743 dreynolds@ablativesolutions.com

Locations
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Belgium
Cliniques Universitaires Saint-Luc Recruiting
Brussels, Belgium, 1200
Contact: Alexandre Persu, MD PhD         
France
Clinique Pasteur Toulouse Recruiting
Toulouse, France
Contact: Atul Pathak, MD, PhD         
Germany
Universitätsklinikum des Saarlandes Recruiting
Homburg/Saar, Germany, 66421
Contact: Felix Mahfoud, Prof.Dr. med         
Principal Investigator: Felix Mahfoud, Prof. Dr. med         
United Kingdom
NIHR Barts Cardiovascular Biomedical Research Unit Recruiting
London, United Kingdom, EC1M 6BQ
Contact: Manish Saxena, MD         
Principal Investigator: Manish Saxena, MD         
Sponsors and Collaborators
Ablative Solutions, Inc.
Investigators
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Principal Investigator: Felix Mahfoud, Prof.Dr.med. Universitätsklinikum des Saarlandes Klinik für Innere Medizin III Kardiologie, Angiologie und Internistische Intensivmedizin, Germany
Principal Investigator: Atul Pathak, Prof. Clinique Pasteur Hi-LAB, Toulouse, France
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Responsible Party: Ablative Solutions, Inc.
ClinicalTrials.gov Identifier: NCT03503773    
Other Study ID Numbers: CR0014
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ablative Solutions, Inc.:
Renal Denervation
Neurolysis
Additional relevant MeSH terms:
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Hypertension
Essential Hypertension
Vascular Diseases
Cardiovascular Diseases