HypertensionRADIANCE CAPNCT05017935
RADIANCE Continued Access Protocol
A study testing Renal Denervation in people with Hypertension and Hypertension, Resistant to Conventional Therapy, run by ReCor Medical, Inc. at 40 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertension, Hypertension, Resistant to Conventional Therapy, Vascular Diseases
- What is being tested?
- Renal Denervation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 40 sitesUnited States
- Study dates
- 4 May 2022to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
40 sites in 1 country.
40 sites in 1 country
United States40 sites
Emory
Atlanta, Georgia, 30308
Lifebridge Health
Baltimore, Maryland, 21215
Boston Medical Center
Boston, Massachusetts, 02118
The Brigham and Women's Hospital
Boston, Massachusetts, 02120
Bridgeport Hospital
Bridgeport, Connecticut, 06610
University of North Carolina
Chapel Hill, North Carolina, 27599-7075
Medical University of South Carolina
Charleston, South Carolina, 29425
Northwestern University
Chicago, Illinois, 60611
Cardiovascular Institute of San Diego
Chula Vista, California, 91911
UnityPoint Health-Des Moines
Des Moines, Iowa, 50309
Henry Ford Hospital
Detroit, Michigan, 48202
Parkview Research Center
Fort Wayne, Indiana, 46845
The Cardiac and Vascular Institute
Gainesville, Florida, 32604
Cone Health
Greensboro, North Carolina, 27401
Cardiovascular Associates of the Delaware Valley
Haddon Heights, New Jersey, 08035
The University of Texas Health Sciences Center at Houston
Houston, Texas, 77030
Saint Luke's Hospital
Kansas City, Missouri, 64111
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Texas Tech University Health Sciences Center
Lubbock, Texas, 79430
Baptist Hospital of Miami
Miami, Florida, 33176
NYU Langone Hospital - Long Island
Mineola, New York, 001501
Ochsner Medical Center
New Orleans, Louisiana, 70121
NYU Langone Health
New York, New York, 10016
Columbia University Medical Center/NYPH
New York, New York, 10032
Orlando Health
Orlando, Florida, 32806
Penn Medicine
Philadelphia, Pennsylvania, 19104
UPMC Heart and Vascular Center
Pittsburgh, Pennsylvania, 15213
NJ Heart & Vascular
Princeton, New Jersey, 08540
Renown Regional Medical Center
Reno, Nevada, 89502
Sutter Health
Sacramento, California, 95816
Tidal Health
Salisbury, Maryland, 21804
University of Texas Health Sciences Center, San Antonio
San Antonio, Texas, 78229
Pacific Heart Institute
Santa Monica, California, 90404
Swedish Health Services
Seattle, Washington, 98122
Prairie Education and Research Cooperative
Springfield, Illinois, 62701
SIU Medicine
Springfield, Illinois, 62794-9664
Stony Brook University Hospital
Stony Brook, New York, 11794-8167
Baylor Scott & White Research Institute
Temple, Texas, 76508
St. Francis Hospital
Tulsa, Oklahoma, 74136
UMASS Memorial Medical Center
Worcester, Massachusetts, 01655
About this study
Official title: RADIANCE Continued Access Protocol (RADIANCE CAP): A Study of the ReCor Medical Paradise System in Clinical Hypertension
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.
- Conditions
- Hypertension, Hypertension, Resistant to Conventional Therapy, Vascular Diseases, Cardiovascular Diseases
- Being tested
- Renal Denervation
- Keywords
- Blood Pressure, Uncontrolled Hypertension, Essential Hypertension, Resistant Hypertension, Denervation
- Medical subject headings
- Hypertension, Hypertension Resistant to Conventional Therapy, Vascular Diseases, Cardiovascular Diseases, Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal DenervationDevice
Renal angiogram and renal denervation (Paradise ultrasound Renal Denervation System)
| Study group | Role | What they receive |
|---|---|---|
| Renal Denervation | Experimental | Not described Receives: Device: Renal Denervation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events
Measured: From baseline to 60 months
Change in average daytime ambulatory systolic BP
Measured: From baseline to 2 months post procedure
Secondary outcomes (5)
Change in average 24-hr/night-time ambulatory systolic BP
Measured: From baseline to 2 months post procedure
Change in average daytime/24-hr/night-time ambulatory systolic BP
Measured: From Baseline to Months 6 and 12 post procedure
Change in average office systolic/diastolic BP
Measured: From Baseline to Months 2, 6, 12, 24, 36, 48, and 60 post procedure
Change in average home systolic/diastolic BP
Measured: From Baseline to Months 2, 6, 12, 24, 36, 48, and 60 post procedure
Change in average 24-hr/night-time ambulatory diastolic BP
Measured: From baseline to Months 2, 6, and 12 post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start4 May 2022
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ReCor Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Naomi Fisher, MD, Principal investigator, Brigham and Women's Hospital/Harvard Medical SchoolAjay Kirtane, MD, SM, Principal investigator, Columbia University Medical Center/NYPH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05017935
- Sponsor's protocol ID
- CLN-0932
- Acronym
- RADIANCE CAP
- Status last verified
- Jun 2024
- First submitted
- 17 Aug 2021
- Last updated
- 17 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 34010611
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RADIANCE Continued Access Protocol (RADIANCE CAP): A Study of the ReCor Medical Paradise System in Clinical Hypertension
- ClinicalTrials.gov ID
- NCT05017935
- Acronym / sponsor ID
- RADIANCE CAP / CLN-0932
- Conditions
- Hypertension, Hypertension, Resistant to Conventional Therapy, Vascular Diseases, Cardiovascular Diseases
- Keywords
- Blood Pressure, Uncontrolled Hypertension, Essential Hypertension, Resistant Hypertension, Denervation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- ReCor Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 May 2022 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 24 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Renal Denervation | Experimental | Device: Renal Denervation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Renal DenervationRenal angiogram and renal denervation (Paradise ultrasound Renal Denervation System) | Device | Renal Denervation |
Primary outcome
Incidence of Adverse Events
Time frame: From baseline to 60 months
Change in average daytime ambulatory systolic BP
Time frame: From baseline to 2 months post procedure
5 secondary outcomes
Change in average 24-hr/night-time ambulatory systolic BP
Time frame: From baseline to 2 months post procedure
Change in average daytime/24-hr/night-time ambulatory systolic BP
Time frame: From Baseline to Months 6 and 12 post procedure
Change in average office systolic/diastolic BP
Time frame: From Baseline to Months 2, 6, 12, 24, 36, 48, and 60 post procedure
Change in average home systolic/diastolic BP
Time frame: From Baseline to Months 2, 6, 12, 24, 36, 48, and 60 post procedure
Change in average 24-hr/night-time ambulatory diastolic BP
Time frame: From baseline to Months 2, 6, and 12 post procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2024.
- Background: PubMed 34010611Azizi 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.
- ReCor Medical company websiteLink provided by the sponsor.
- Study eligibility questionnaire; study summary and informationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naomi Fisher, MD principal investigator
Brigham and Women's Hospital/Harvard Medical School
Ajay Kirtane, MD, SM principal investigator
Columbia University Medical Center/NYPH
40 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Renal Denervation in people with Hypertension and Hypertension, Resistant to Conventional Therapy, run by ReCor Medical, Inc. at 40 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (time frame: From baseline to 60 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05017935, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2024.