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The TARGET BP OFF-MED Trial

Primary Purpose

Hypertension, Hypertension,Essential

Status

Active

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Alcohol

Sham control

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Renal Denervation, Neurolysis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Cliniques Universitaires Saint-Luc
Clinique Pasteur Toulouse
Universitätsklinikum des Saarlandes
NIHR Barts Cardiovascular Biomedical Research Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Treatment Arm:

Sham Control Arm

Arm Description

Renal denervation (using the Peregrine Kit) performed with alcohol infused through the Peregrine Catheter

Only renal angiography performed

Outcomes

Primary Outcome Measures

Changes in Systolic Ambulatory Blood Pressure

Change in mean 24-hour ambulatory SBP

Secondary Outcome Measures

Changes in Ambulatory Blood Pressure

Change in mean 24-hour, daytime, and nighttime ambulatory SBP and DBP

Changes in Office Blood Pressure

Change in mean office SBP and DBP

Use of antihypertensive medication(s)

Evaluate differences between groups

Evaluation of safety

Major adverse events (MAEs)

Full Information

NCT ID

NCT03503773

First Posted

March 23, 2018

Last Updated

July 21, 2023

Sponsor

Ablative Solutions, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03503773

Brief Title

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

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

September 24, 2018 (Actual)

Primary Completion Date

January 31, 2022 (Actual)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ablative Solutions, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension, Hypertension,Essential

Keywords

Renal Denervation, Neurolysis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

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

ParticipantOutcomes 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.)

Allocation

Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment Arm:

Arm Type

Experimental

Arm Description

Renal denervation (using the Peregrine Kit) performed with alcohol infused through the Peregrine Catheter

Arm Title

Sham Control Arm

Arm Type

Sham Comparator

Arm Description

Only renal angiography performed

Intervention Type

Drug

Intervention Name(s)

Alcohol

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Sham control

Intervention Description

endovascular, renal angiography

Primary Outcome Measure Information:

Title

Changes in Systolic Ambulatory Blood Pressure

Description

Change in mean 24-hour ambulatory SBP

Time Frame

Baseline to 8 weeks post-treatment

Secondary Outcome Measure Information:

Title

Changes in Ambulatory Blood Pressure

Description

Change in mean 24-hour, daytime, and nighttime ambulatory SBP and DBP

Time Frame

Baseline, and 8 weeks, 6 months, 12 months post treatment

Title

Changes in Office Blood Pressure

Description

Change in mean office SBP and DBP

Time Frame

Baseline, and 4 weeks, 8 weeks, 3 months, 6 months, 1 year and 2 years post treatment

Title

Use of antihypertensive medication(s)

Description

Evaluate differences between groups

Time Frame

8 weeks, 6 months,1 year post treatment

Title

Evaluation of safety

Description

Major adverse events (MAEs)

Time Frame

30 days post procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Felix Mahfoud, Prof.Dr.med.

Organizational Affiliation

Universitätsklinikum des Saarlandes Klinik für Innere Medizin III Kardiologie, Angiologie und Internistische Intensivmedizin, Germany

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Atul Pathak, Prof.

Organizational Affiliation

Clinique Pasteur Hi-LAB, Toulouse, France

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cliniques Universitaires Saint-Luc

City

Brussels

ZIP/Postal Code

1200

Country

Belgium

Facility Name

Clinique Pasteur Toulouse

City

Toulouse

Country

France

Facility Name

Universitätsklinikum des Saarlandes

City

Homburg/Saar

ZIP/Postal Code

66421

Country

Germany

Facility Name

NIHR Barts Cardiovascular Biomedical Research Unit

City

London

ZIP/Postal Code

EC1M 6BQ

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

32958438

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.

Results Reference

derived

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The TARGET BP OFF-MED Trial

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