A Study of the ReCor Medical Paradise System in Clinical Hypertension

Hypertension Clinical Trial

— RADIANCE-HTN  

Official title:

The "RADIANCE-HTN" Study. A Study of the ReCor Medical Paradise System in Clinical Hypertension

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02649426
• Other study ID #: CLN 0777
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 2016
• Est. completion date: May 2025

Study information

• Verified date: August 2022
• Source: ReCor Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

RADIANCE-HTN is a randomized, double-blind, sham controlled, 2-cohort study (TRIO and SOLO) designed to demonstrate efficacy and document the safety of the Paradise Renal Denervation System in two distinct populations of hypertensive subjects.

Description:

Subjects with essential hypertension controlled on 1 or 2 antihypertensive medications or uncontrolled on 0-2 antihypertensive medications will be included in the RADIANCE Solo cohort while subjects with treatment resistant hypertension on a minimum of 3 antihypertensive medications will be included in the RADIANCE Trio cohort. Prior to randomization, subjects will be hypertensive in the absence of hypertension medication (SOLO) or despite the presence of a stabilized, single pill, triple, fixed dose antihypertensive medication regimen (TRIO).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 292
• Est. completion date: May 2025
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

TRIO and SOLO Inclusion Criteria:

• Appropriately signed and dated informed consent

• Age =18 and =75 years at time of consent

• Documented history of essential hypertension

• SOLO Cohort only: Either an average seated office BP < 180/110 mmHg at screening visit while on a stable regimen of 1 or 2 antihypertensive medications for at least 4 weeks prior to consent or an average seated office BP = 140/90 mmHg <180/110 mmHg despite lifestyle measures on no antihypertensive medications

• TRIO Cohort only: Average seated office BP = 140/90 mmHg at screening visit while on a stable regimen of at least 3 antihypertensive medications of different classes including a diuretic for at least 4 weeks prior to consent

• Documented daytime ABP = 135/85 mmHg and < 170/105 mmHg after 4-week washout/run-in period (SOLO cohort) or after 4-week stabilization period (TRIO cohort)

• Suitable renal anatomy compatible with the renal denervation procedure and documented by renal CTA or MRA of good quality performed within one year prior to consent (a CTA or MRA will be obtained in patients without a recent (=1 year) renal imaging)

• Able and willing to comply with all study procedures

Solo Exclusion Criteria:

• Renal artery anatomy on either side, ineligible for treatment including:

• Main renal artery diameter < 4 mm and > 8 mm

• Main renal artery length < 25 mm

• A single functioning kidney

• Presence of abnormal kidney (or secreting adrenal) tumors

• Renal artery with aneurysm

• Pre-existing renal stent or history of renal artery angioplasty

• Prior renal denervation procedure

• Fibromuscular disease of the renal arteries

• Presence of renal artery stenosis of any origin = 30%

• Accessory arteries with diameter = 2mm <4 mm and > 8 mm*

• Evidence of active infection within 7 days of procedure

• Iliac/femoral artery stenosis precluding insertion of the Paradise Catheter

• Type I diabetes mellitus or uncontrolled Type II diabetes (defined as a plasma Hb1Ac = 9.0%)

• Documented history of chronic active inflammatory bowel disorders such as Chrohn's disease or ulcerative colitis

• eGFR of <40 mL/min/1.73 m2 (by Modification of Diet in Renal Disease formula)

• Brachial circumference = 42 cm

• Any history of cerebrovascular event (e.g. stroke, transient ischemic event, cerebrovascular accident)

• Any history of severe cardiovascular event (myocardial infarction, CABG, acute heart failure requiring hospitalization (NYHA III-IV)

• Documented confirmed episode(s) of stable or unstable angina

• Documented repeat (>1) hospitalization for hypertensive crisis within the prior 12 months

• Prescribed to any standard antihypertensive of cardiovascular medication (e.g. beta blockers) for other chronic conditions (e.g. ischemic heart disease) such that discontinuation might pose serious risk to health

• Documented history of persistent or permanent atrial tachyarrhythmia

• Active implantable medical device (e.g. ICD or CRT-D; neuromodulator/spinal stimulator; baroreflex stimulator)

• Chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea.

• Primary pulmonary hypertension

• Documented contraindication or allergy to contrast medium not amenable to treatment

• Limited life expectancy of < 1 year at the discretion of the Investigator

• Any known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or for any reason in the opinion of the investigator, would be unlikely or unable to comply with study protocol requirements or whose participation may result in data analysis confounders (e.g. night shift workers)

• Pregnant, nursing or planning to become pregnant (negative pregnancy test required, documented within a maximum of 7 days prior to procedure for all women of child bearing potential. Documentation of effective contraception is also required for women of child bearing potential) Concurrent enrollment in any other investigational drug or device trial (participation in non-interventional Registries is acceptable)

TRIO Exclusion Criteria

• Renal artery anatomy on either side, ineligible for treatment including:

• Main renal artery diameter < 3.5 mm and > 8 mm

• Main renal artery length < 20 mm

• A single functioning kidney

• Presence of abnormal kidney tumors

• Renal artery with aneurysm

• Pre-existing renal stent or history of renal artery angioplasty

• Pre-existing aortic stent or history of aortic aneurysm

• Prior renal denervation procedure

• Fibromuscular disease of the renal arteries

• Presence of renal artery stenosis of any origin = 30%

• Accessory arteries with diameter =2 mm <3.5 mm and > 8 mm*

• Iliac/femoral artery stenosis precluding insertion of the Paradise Catheter

• Evidence of active infection within 7 days of procedure

• Secondary hypertension not including sleep apnea (documented through clinical work up within the 12 months prior to consent- see protocol body for details)

• Type I diabetes mellitus or uncontrolled Type II diabetes (defined as a plasma Hb1Ac = 9.0%)

• Documented history of chronic active inflammatory bowel disorders such as Crohn's disease or ulcerative colitis

• eGFR of <40 mL/min/1.73 m2 (by Modification of Diet in Renal Disease formula)

• Brachial circumference = 42 cm

• Any history of cerebrovascular event (e.g. stroke, transient ischemic event, cerebrovascular accident) within 3 months prior to consent

• Any history of severe cardiovascular event (e.g. myocardial infarction, CABG, acute heart failure requiring hospitalization (NYHA III-IV) within 3 months prior to consent

• Documented repeat (>1) hospitalization for hypertensive crisis within the prior 3 months

• Documented confirmed episode(s) of unstable angina within 3 months prior to consent

• Documented intolerance or contraindication for any of the antihypertensive drugs prescribed as a requirement of the study protocol

• Prescribed to any standard anti-hypertensive CV medication (other than beta blockers) for other chronic conditions (e.g. ischemic heart disease) such that discontinuation might pose serious risk to health

• Documented history of persistent or permanent atrial tachyarrhythmia

• Active implantable medical device (e.g. ICD or CRT-D; neuromodulator/spinal stimulator; baroreflex stimulator)

• Chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea.

• Primary pulmonary hypertension

• Documented contraindication or allergy to contrast medium not amenable to treatment

• Limited life expectancy of < 1 year at the discretion of the Investigator

• Night shift workers

• Any known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or for any reason in the opinion of the investigator, would be unlikely or unable to comply with study protocol requirements or whose participation may result in data analysis confounders

• Pregnant, nursing or planning to become pregnant (documented negative pregnancy test required documented within a maximum of 7 days prior to procedure for all women of child bearing potential. Documentation of effective contraception is also required for women of child bearing potential)

• Concurrent enrollment in any other investigational drug or device trial (participation in non-interventional Registries is acceptable)

Related Conditions & MeSH terms

• Hypertension
• Vascular Diseases

Intervention

Device:
• The Paradise® Renal Denervation Ultrasound System
Randomization will occur following the diagnostic renal angiogram. Blinded patients randomized to treatment will receive the renal denervation procedure using the Paradise System to deliver ultrasound energy to thermally ablate and disrupt the renal sympathetic nerves while sparing the renal arterial wall.
• Sham Procedure
Randomization will occur following the diagnostic renal angiogram. For blinded patients randomized to control, the diagnostic renal angiogram will be considered the sham procedure.

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires St Luc	Brussels
France	Hôpital Saint-André - CHU Bordeaux	Bordeaux
France	CHRU Lille - Institut Coeur Poumon	Lille
France	Hôpital de la Croix Rousse	Lyon
France	Hôpital Européen Georges-Pompidou	Paris
France	Clinique Pasteur	Toulouse
Germany	University Clinic Dusseldorf	Dusseldorf
Germany	University Clinic Erlangen	Erlangen
Germany	Universitäts-Herzzentrum Freiburg-Bad Krozingen GmbH	Freiburg
Germany	University Clinic of Saarland	Homburg
Germany	Leipzig Heart Center	Leipzig
Germany	Sana Kliniken Lübeck GmbH	Lübeck
Germany	Katholisches Klinikum Mainz	Mainz
Netherlands	Maastricht University Hospital	Maastricht
Netherlands	Erasmus Medical Center	Rotterdam
Netherlands	University Medical Center Utrecht	Utrecht
Poland	Medical University of Gdansk	Gdansk
Poland	Institute of Cardiology	Warsaw
United Kingdom	The Essex Cardiothoracic Centre - Basildon & Thurrock University Hospitals	Basildon
United Kingdom	Royal Bournemouth Hospital	Bournemouth	England
United Kingdom	Royal Devon and Exeter Hospital (Wonford)	Exeter
United Kingdom	Conquest Hospital - Hastings	Hastings
United Kingdom	Imperial College London, Hammersmith Hospital	London	England
United Kingdom	St Bartholomew's Hospital	London
United Kingdom	Nottingham University Hospitals NHS Trust	Nottingham
United States	Emory University Hospital Midtown	Atlanta	Georgia
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	The Brigham and Women's Hospital	Boston	Massachusetts
United States	Deborah Heart and Lung Center	Browns Mills	New Jersey
United States	University of North Carolina at Chapel Hill School of Medicine	Chapel Hill	North Carolina
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Cleveland Clinic	Cleveland	Ohio
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	The Cardiac and Vascular Institute	Gainesville	Florida
United States	Franciscan Health Indianapolis	Indianapolis	Indiana
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Minneapolis Heart Institute	Minneapolis	Minnesota
United States	Vanderbilt University	Nashville	Tennessee
United States	Ochsner Heart and Vascular Insitute	New Orleans	Louisiana
United States	Columbia University / NewYork Presbyterian Hospital	New York	New York
United States	New York University School of Medicine	New York	New York
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	The Heart Hospital Baylor Plano	Plano	Texas
United States	Renown Institute for Heart& Vascular Health	Reno	Nevada
United States	Sutter Health Medical Center	Sacramento	California
United States	University of Utah	Salt Lake City	Utah
United States	Southern Illinois University Medicine	Springfield	Illinois
United States	Stamford Hospital	Stamford	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
ReCor Medical, Inc.

Countries where clinical trial is conducted

United States,  Belgium,  France,  Germany,  Netherlands,  Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean reduction in average daytime ambulatory systolic BP		from baseline to 2 months post procedure
Secondary	Reduction in average 24-hr/night-time ambulatory systolic BP		from baseline to 2 months post procedure
Secondary	Reduction in average daytime/24-hr/night-time diastolic BP		from baseline to 2 months post procedure
Secondary	All-cause mortality		from baseline to 36 months post-procedure
Secondary	Hypertensive or hypotensive emergency resulting in hospitalization		up to 36 months
Secondary	Hospitalization for heart failure		from baseline to 36 months post-procedure
Secondary	Stroke, transient ischemic attack, cerebrovascular accident		from baseline to 36 months post-procedure
Secondary	Acute myocardial infarction		from baseline to 36 months post-procedure
Secondary	End stage renal disease		from baseline to 36 months post-procedure
Secondary	Renal artery or vascular complications requiring intervention		from baseline to 36 months post-procedure
Secondary	Significant embolic events resulting in end organ damage		from baseline to 1 month and 36 months post-procedure
Secondary	Procedure related pain lasting > 2 days		from baseline to 1 month and 36 months post-procedure
Secondary	Acute renal injury		from baseline to 1 month and 36 months post-procedure
Secondary	Significant (>50%) and severe (>75%) new onset renal stenosis	as diagnosed by duplex ultrasound and confirmed by renal CTA/MRA or as diagnosed/confirmed by study defined renal CTA/MRA at 12 months	from baseline to 6, 12, 24 and 36 months post-procedure
Secondary	Major access site complications		from baseline to 1 month and 36 months post-procedure