NCT02910414

Brief Summary

The TARGET BP I Trial is a randomized, blinded, multi-center, international, sham-procedure controlled trial, comparing renal denervation performed with the Peregrine System Kit in the treatment group to the sham control group (without renal denervation - no alcohol infusion). Subjects will be randomized in a 1:1 fashion to treatment versus sham control via central randomization.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P50-P75 for phase_3 hypertension

Timeline
Completed

Started Jul 2019

Longer than P75 for phase_3 hypertension

Geographic Reach
1 country

5 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 22, 2016

Completed
2.8 years until next milestone

Study Start

First participant enrolled

July 22, 2019

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

October 3, 2023

Status Verified

October 1, 2023

Enrollment Period

4.4 years

First QC Date

September 16, 2016

Last Update Submit

October 2, 2023

Conditions

Hypertension

Keywords

Renal DenervationAlcohol

Outcome Measures

Primary Outcomes (1)

  • Change in mean systolic ABPM

    The change in mean 24-hour ambulatory SBP from baseline to 3 months post-procedure

    3 months

Secondary Outcomes (23)

  • Proportion of subjects with major adverse events

    30 days

  • Major Adverse Events

    3, 6, and 12 months and 2 and 3 years

  • Decrease in eGFR > 25%

    3 and 6 months

  • Changes in eGFR

    3 and 6 months

  • Adverse event rate

    Procedure date, discharge date (an average of 1 day), 5-day, 4 weeks, 8 weeks, 3 months, 4 months, 5 months, 6 months, 1 year, 2 years and 3 years

  • +18 more secondary outcomes

Study Arms (2)

Treated with Peregrine System Kit

EXPERIMENTAL

The experimental group will receive an infusion of Dehydrated Alcohol Injection, USP into the perivascular space of the renal arteries with the Peregrine Catheter. A total of 0.6mL of the alcohol will be delivered to the perivascular space of each renal artery. The drug will only be delivered once to each renal artery during the treatment procedure.

Drug: Dehydrated alcohol

Renal Angiography Only (Sham Procedure)

SHAM COMPARATOR

The sham control group will only have diagnostic renal angiography performed. There will be no insertion of the Peregrine Catheter and no alcohol infusion (i.e. no renal denervation).

Device: Peregrine System Kit (Sham Procedure)

Interventions

Dehydrated alcoholDRUG

Dehydrated Alcohol Injection, USP is used in the study.

Also known as: Ethanol
Treated with Peregrine System Kit
Peregrine System Kit (Sham Procedure)DEVICE

Pre-procedural diagnostic renal angiography only, performed for confirmation of anatomical eligibility prior to randomization

Renal Angiography Only (Sham Procedure)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 when receiving 2 to 5 antihypertensive medications.
  • Has a mean 24-hour ambulatory SBP of ≥135 mmHg and ≤170 mmHg with ≥70% valid readings

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Cardiology PC

Birmingham, Alabama, 35211, United States

Location

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

Location

NC Heart and Vascular Research

Raleigh, North Carolina, 27607, United States

Location

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Related Publications (2)

  • Kandzari DE, Weber MA, Pathak A, Zidar JP, Saxena M, David SW, Schmieder RE, Janas AJ, Langer C, Persu A, Mendelsohn FO, Ameloot K, Foster M 3rd, Fischell TA, Parise H, Mahfoud F. Effect of Alcohol-Mediated Renal Denervation on Blood Pressure in the Presence of Antihypertensive Medications: Primary Results From the TARGET BP I Randomized Clinical Trial. Circulation. 2024 Jun 11;149(24):1875-1884. doi: 10.1161/CIRCULATIONAHA.124.069291. Epub 2024 Apr 8.

    PMID: 38587557DERIVED

  • 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.

    PMID: 32958438DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Officials

  • David Kandzari, MD

    Piedmont Heart Institute

    PRINCIPAL INVESTIGATOR

  • Michael Weber, MD

    SUNY Downstate Medical

    PRINCIPAL INVESTIGATOR

  • Atul Pathak, MD

    Clinique Pasteur

    PRINCIPAL INVESTIGATOR

  • Felix Mahfoud, MD

    Klinik fur Innere Medizin III

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2016

First Posted

September 22, 2016

Study Start

July 22, 2019

Primary Completion

December 1, 2023

Study Completion

May 1, 2026

Last Updated

October 3, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

US(5)