Clinical trial NCT02392351: Renal Denervation Using the Vessix Renal Denervation System for the Treatment of Hypertension (REDUCE HTN:REINFORCE)
Official title: A Boston Scientific Clinical Trial of Renal Denervation Using the Vessix Reduce™ Catheter and Vessix™ Generator for the Treatment of HyperTensioN: REINFORCE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Hypertension
Renal Denervation
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2015-03-19
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The REDUCE HTN: REINFORCE study is being conducted to determine whether the Vessix Reduce™ Catheter and Vessix™ Generator for the treatment of uncontrolled hypertension (off-treatment office systolic blood pressure ≥150 mmHg and ≤180 mmHg) shows acceptable performance at 8 weeks when compared to a masked procedure (renal angiogram).

Detailed description: Prospective, multicenter, single blinded, randomized, controlled, pilot study. Subjects will be randomized to renal denervation treatment or masked renal angiogram procedure (2:1).

Eligibility criteria: Inclusion Criteria:

* Age ≥18 and ≤75 years
* OSBP ≥150 mmHg and ≤180 mmHg based on an average of 3 office-based blood pressure measurements
* Average 24-hour ASBP ≥135 mmHg and ≤170 mmHg
* For each kidney, a main renal artery, with or without accessory renal arteries, with diameter ≥3.0 mm and ≤7.0 mm and length ≥20.0 mm
* Agrees to have all study procedures performed, and is competent and willing to provide written, informed consent

Exclusion Criteria:

* Stenosis \>30% or renal artery aneurysm in either renal artery
* Fibromuscular dysplasia (FMD)
* Known causes of secondary HTN
* Type 1 diabetes mellitus
* eGFR \<40 mL/min/1.73m2
* Known ejection fraction of \<30% or heart failure that required hospitalization in the previous 6 months
* Severe valvular heart disease
* ≥1 episode(s) of orthostatic hypotension not related to medication changes (reduction of SBP of ≥20 mmHg or DBP of ≥10 mmHg within three minutes of standing) coupled with symptoms within the past year or during screening

Primary outcomes:
measure: OBSERVATIONAL: Change (Mean Reduction) in Average 24-hour Ambulatory Systolic Blood Pressure (ASBP) Through 8 Weeks
timeFrame: Through 8 weeks
Secondary outcomes:
measure: Number of Hospitalizations Due to Severe Hypotension/Syncope
timeFrame: Through 6 months
measure: Significant Embolic Event Resulting in End-organ Damage or Intervention to Prevent it
timeFrame: 4 weeks
measure: Renal Artery Dissection or Perforation Requiring Intervention
timeFrame: 4 weeks
measure: Vascular Complications
timeFrame: 4 weeks
measure: Significant New Renal Artery Stenosis
timeFrame: 6 months
measure: Number of Subjects Utilizing Anti-hypertensive Medications
timeFrame: 3 months
measure: Mean Reduction in Average 24-hour Ambulatory Systolic Blood Pressure at 6 Months
timeFrame: 6 Months
measure: Mean Reduction in Average 24-hour Ambulatory Diastolic Blood Pressure Through 6 Months
timeFrame: 6 Months
measure: Number of Subjects Utilizing Anti-hypertensive Medications
timeFrame: 6 months
measure: Mean Reduction in Average 24-Hour Ambulatory Systolic Blood Pressure
timeFrame: 12 Months
measure: Mean Reduction in Average 24-hour Ambulatory Diastolic Blood Pressure
timeFrame: 12 Months
measure: All-Cause Death
timeFrame: 24 Months
measure: Number of Participants With Renal Failure
timeFrame: 24 Months
measure: Number of Participants With Hypertensive Crisis
timeFrame: 24 Months
measure: Mean Reduction in Average Office-based Systolic Blood Pressure
timeFrame: 24 Months
measure: Mean Reduction in Average Office-based Diastolic Blood Pressure
timeFrame: 24 Months
measure: Percent of Subjects at Target Blood Pressure
timeFrame: 24 Months
measure: Congestive Heart Failure
timeFrame: 24 Months
measure: Myocardial Infarction
timeFrame: 24 Months
measure: Stroke
timeFrame: 24 Months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cardiology, PC
state: Alabama
city: Los Angeles
country: United States
facility: Cedars - Sinai Medical Center
state: California
city: Miami Beach
country: United States
facility: Mount Sinai Medical Center
state: Florida
city: Houma
country: United States
facility: Cardiovascular Institute of the South
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Philadelphia
country: United States
facility: Albert Einstein Medical Center
state: Pennsylvania
city: Kingsport
country: United States
facility: Wellmont CVA Heart Institute
state: Tennessee
city: Dallas
country: United States
facility: Dallas Medical Center
state: Texas
city: Dallas
country: United States
facility: Cardiovascular Research Institute of Dallas
state: Texas
city: Wausau
country: United States
facility: Aspirus Heart and Vascular Institute
state: Wisconsin
Study officials:
affiliation: Columbia University
name: Martin B Leon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: SUNY Downstate College of Medicine
name: Michael Weber, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Weber MA, Kirtane AJ, Weir MR, Radhakrishnan J, Das T, Berk M, Mendelsohn F, Bouchard A, Larrain G, Haase M, Diaz-Cartelle J, Leon MB. The REDUCE HTN: REINFORCE: Randomized, Sham-Controlled Trial of Bipolar Radiofrequency Renal Denervation for the Treatment of Hypertension. JACC Cardiovasc Interv. 2020 Feb 24;13(4):461-470. doi: 10.1016/j.jcin.2019.10.061.