Clinical trial NCT05017935: RADIANCE Continued Access Protocol
Official title: RADIANCE Continued Access Protocol (RADIANCE CAP): A Study of the ReCor Medical Paradise System in Clinical Hypertension
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hypertension
Hypertension, Resistant to Conventional Therapy
Vascular Diseases
Cardiovascular Diseases
Keywords: Blood Pressure
Uncontrolled Hypertension
Essential Hypertension
Resistant Hypertension
Denervation
Lead sponsor: ReCor Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2021-08-24
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: RADIANCE CAP is a non-randomized study designed to allow for continued access to ultrasound renal denervation therapy via the Paradise System, and to allow for the on-going collection of safety and effectiveness data in subjects with uncontrolled hypertension despite the prescription of antihypertensive medications.


Eligibility criteria: Inclusion Criteria:

* Average office BP ≥140/90 mmHg at screening visit despite taking stables doses of antihypertensive medications for at least 4 weeks prior to consent
* Documented daytime ABP ≥135/85 mmHg following 4 week run-in/standardization period on antihypertensive medication regimen

Exclusion Criteria:

* Renal artery anatomy ineligible for treatment
* Secondary hypertension not including sleep apnea
* Type I diabetes mellitus or uncontrolled Type II diabetes (defined as plasma HbA1c ≥9.0%)
* eGFR \<40
* Brachial circumference ≥42 cm
* Any history of cerebrovascular event or severe cardiovascular event within 3 months prior to consent
* Documented repeat (\>1) hospitalization for hypertensive crisis within 3 months prior to consent
* Documented confirmed episode(s) of unstable angina within 3 months prior to consent
* Chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea
* Primary pulmonary hypertension
* Night shift workers
* Pregnant, nursing or planning to become pregnant

Primary outcomes:
measure: Incidence of Adverse Events
timeFrame: From baseline to 60 months
measure: Change in average daytime ambulatory systolic BP
timeFrame: From baseline to 2 months post procedure
Secondary outcomes:
measure: Change in average 24-hr/night-time ambulatory systolic BP
timeFrame: From baseline to 2 months post procedure
measure: Change in average daytime/24-hr/night-time ambulatory systolic BP
timeFrame: From Baseline to Months 6 and 12 post procedure
measure: Change in average office systolic/diastolic BP
timeFrame: From Baseline to Months 2, 6, 12, 24, 36, 48, and 60 post procedure
measure: Change in average home systolic/diastolic BP
timeFrame: From Baseline to Months 2, 6, 12, 24, 36, 48, and 60 post procedure
measure: Change in average 24-hr/night-time ambulatory diastolic BP
timeFrame: From baseline to Months 2, 6, and 12 post procedure
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: Cardiovascular Institute of San Diego
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Sacramento
country: United States
facility: Sutter Health
state: California
city: Santa Monica
country: United States
facility: Pacific Heart Institute
state: California
city: Bridgeport
country: United States
facility: Bridgeport Hospital
state: Connecticut
city: Gainesville
country: United States
facility: The Cardiac and Vascular Institute
state: Florida
city: Miami
country: United States
facility: Baptist Hospital of Miami
state: Florida
city: Orlando
country: United States
facility: Orlando Health
state: Florida
city: Atlanta
country: United States
facility: Emory
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Springfield
country: United States
facility: Prairie Education and Research Cooperative
state: Illinois
city: Springfield
country: United States
facility: SIU Medicine
state: Illinois
city: Fort Wayne
country: United States
facility: Parkview Research Center
state: Indiana
city: Des Moines
country: United States
facility: UnityPoint Health-Des Moines
state: Iowa
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Baltimore
country: United States
facility: Lifebridge Health
state: Maryland
city: Salisbury
country: United States
facility: Tidal Health
state: Maryland
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Boston
country: United States
facility: The Brigham and Women's Hospital
state: Massachusetts
city: Worcester
country: United States
facility: UMASS Memorial Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Kansas City
country: United States
facility: Saint Luke's Hospital
state: Missouri
city: Reno
country: United States
facility: Renown Regional Medical Center
state: Nevada
city: Haddon Heights
country: United States
facility: Cardiovascular Associates of the Delaware Valley
state: New Jersey
city: Princeton
country: United States
facility: NJ Heart & Vascular
state: New Jersey
city: Mineola
country: United States
facility: NYU Langone Hospital - Long Island
state: New York
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: New York
country: United States
facility: Columbia University Medical Center/NYPH
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Hospital
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Greensboro
country: United States
facility: Cone Health
state: North Carolina
city: Tulsa
country: United States
facility: St. Francis Hospital
state: Oklahoma
city: Philadelphia
country: United States
facility: Penn Medicine
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Heart and Vascular Center
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Houston
country: United States
facility: The University of Texas Health Sciences Center at Houston
state: Texas
city: Lubbock
country: United States
facility: Texas Tech University Health Sciences Center
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Sciences Center, San Antonio
state: Texas
city: Temple
country: United States
facility: Baylor Scott & White Research Institute
state: Texas
city: Seattle
country: United States
facility: Swedish Health Services
state: Washington
Study officials:
affiliation: Brigham and Women's Hospital/Harvard Medical School
name: Naomi Fisher, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University Medical Center/NYPH
name: Ajay Kirtane, MD, SM
role: PRINCIPAL_INVESTIGATOR
References:
citation: Azizi M, Sanghvi K, Saxena M, Gosse P, Reilly JP, Levy T, Rump LC, Persu A, Basile J, Bloch MJ, Daemen J, Lobo MD, Mahfoud F, Schmieder RE, Sharp ASP, Weber MA, Sapoval M, Fong P, Pathak A, Lantelme P, Hsi D, Bangalore S, Witkowski A, Weil J, Kably B, Barman NC, Reeve-Stoffer H, Coleman L, McClure CK, Kirtane AJ; RADIANCE-HTN investigators. Ultrasound renal denervation for hypertension resistant to a triple medication pill (RADIANCE-HTN TRIO): a randomised, multicentre, single-blind, sham-controlled trial. Lancet. 2021 Jun 26;397(10293):2476-2486. doi: 10.1016/S0140-6736(21)00788-1. Epub 2021 May 16.