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HypertensionNCT02392351

Renal Denervation Using the Vessix Renal Denervation System for the Treatment of Hypertension (REDUCE HTN:REINFORCE)

A study testing Renal Denervation (Vessix) and Renal Angiography in people with Hypertension, run by Boston Scientific Corporation at 12 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Hypertension
What is being tested?
Renal Denervation (Vessix) and Renal Angiography
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
51 participants
Where
12 sitesUnited States
Study dates
Apr 2015to 2 Aug 2019
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • 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

Who cannot join

  • 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

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

United States12 sites

  • University of Maryland

    Baltimore, Maryland, 21201

  • Cardiology, PC

    Birmingham, Alabama, 35211

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Dallas Medical Center

    Dallas, Texas, 75006

  • Cardiovascular Research Institute of Dallas

    Dallas, Texas, 75231

  • Cardiovascular Institute of the South

    Houma, Louisiana, 70360

  • Wellmont CVA Heart Institute

    Kingsport, Tennessee, 37660

  • Cedars - Sinai Medical Center

    Los Angeles, California, 90048

  • Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Columbia University Medical Center

    New York, New York, 10032

  • Albert Einstein Medical Center

    Philadelphia, Pennsylvania, 19141

  • Aspirus Heart and Vascular Institute

    Wausau, Wisconsin, 54401

Other trials in United States

About this study

Official title: A Boston Scientific Clinical Trial of Renal Denervation Using the Vessix Reduce™ Catheter and Vessix™ Generator for the Treatment of HyperTensioN: REINFORCE

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).

Read the 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).

Conditions
Hypertension
Being tested
Renal Denervation (Vessix), Renal Angiography
Keywords
Hypertension, Renal Denervation
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Renal Denervation (Vessix)Device

    Also called Vessix Reduce™ Catheter and Vessix™ Generator, Vessix Renal Denervation System

    Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator

  • Renal AngiographyDevice

    Also called Renal Angiogram

    Percutaneous renal angiography

Study groups in NCT02392351
Study groupRoleWhat they receive
Renal DenervationExperimentalPercutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator (Vessix Renal Denervation System).
Receives: Device: Renal Denervation (Vessix)
Masked ProcedureSham comparatorPercutaneous renal angiography
Receives: Device: Renal Angiography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. OBSERVATIONAL: Change (Mean Reduction) in Average 24-hour Ambulatory Systolic Blood Pressure (ASBP) Through 8 Weeks

    Change (mean reduction) in average 24-hour Ambulatory Systolic Blood Pressure (ASBP) through 8 weeks post randomization in subjects treated with renal denervation (Test) and subjects treated with masked procedure (Control)

    Measured: Through 8 weeks

Secondary outcomes (20)

  1. Number of Hospitalizations Due to Severe Hypotension/Syncope

    Number of hospitalizations due to severe hypotension/syncope through 6 months.

    Measured: Through 6 months

  2. Significant Embolic Event Resulting in End-organ Damage or Intervention to Prevent it

    Number of subjects experiencing a significant embolic event resulting in end-organ damage or intervention to prevent end-organ damage through 4 weeks.

    Measured: 4 weeks

  3. Renal Artery Dissection or Perforation Requiring Intervention

    Number of renal artery dissection or perforation requiring intervention through 4 weeks.

    Measured: 4 weeks

  4. Vascular Complications

    Number of vascular complications through 4 weeks.

    Measured: 4 weeks

  5. Significant New Renal Artery Stenosis

    Number of significant new renal artery stenosis events through 6 months.

    Measured: 6 months

  6. Number of Subjects Utilizing Anti-hypertensive Medications

    Number of subjects utilizing anti-hypertensive medications at 3 months.

    Measured: 3 months

  7. Mean Reduction in Average 24-hour Ambulatory Systolic Blood Pressure at 6 Months

    Change (mean reduction) in the average 24-hour ambulatory systolic blood pressure at 6 months compared to baseline

    Measured: 6 Months

  8. Mean Reduction in Average 24-hour Ambulatory Diastolic Blood Pressure Through 6 Months

    Change (mean reduction) in average 24-hour ambulatory diastolic blood pressure at 6 months compared to baseline.

    Measured: 6 Months

  9. Number of Subjects Utilizing Anti-hypertensive Medications

    Number of subjects utilizing anti-hypertensive medications at 6 months

    Measured: 6 months

  10. Mean Reduction in Average 24-Hour Ambulatory Systolic Blood Pressure

    Mean Reduction in Average 24-Hour Ambulatory systolic blood pressure at 12 months

    Measured: 12 Months

  11. Mean Reduction in Average 24-hour Ambulatory Diastolic Blood Pressure

    Mean reduction in average 24-hour ambulatory diastolic blood pressure at 12 months

    Measured: 12 Months

  12. All-Cause Death

    Number of all causes of death through 24 months

    Measured: 24 Months

  13. Number of Participants With Renal Failure

    Number of renal failure events through 24 months

    Measured: 24 Months

  14. Number of Participants With Hypertensive Crisis

    Number of hypertensive crisis events through 24 months

    Measured: 24 Months

  15. Mean Reduction in Average Office-based Systolic Blood Pressure

    Mean Reduction in Average office-based systolic blood pressure through 24 months

    Measured: 24 Months

  16. Mean Reduction in Average Office-based Diastolic Blood Pressure

    Mean Reduction in Office-based diastolic blood pressure through 24 months

    Measured: 24 Months

  17. Percent of Subjects at Target Blood Pressure

    Percent of subjects at target blood pressure through 24 months

    Measured: 24 Months

  18. Congestive Heart Failure

    Number of subjects with congestive heart failure through 24 months

    Measured: 24 Months

  19. Myocardial Infarction

    Number of subjects who experience myocardial infarction through 24 months

    Measured: 24 Months

  20. Stroke

    Number of subjects experiencing stroke through 24 months

    Measured: 24 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2015 (estimated)
  2. Study startApr 2015
  3. Primary completion7 Sep 2017
  4. Study completion2 Aug 2019

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02392351
Sponsor's protocol ID
S2333
Status last verified
Jan 2021
First submitted
13 Mar 2015
Last updated
11 Feb 2021
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • 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.

    PubMed 32081240

Questions about this trial

What is this clinical trial studying?

A study testing Renal Denervation (Vessix) and Renal Angiography in people with Hypertension, run by Boston Scientific Corporation at 12 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 5 inclusion and 8 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: finished, as of the sponsor's last update on 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 4 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

OBSERVATIONAL: Change (Mean Reduction) in Average 24-hour Ambulatory Systolic Blood Pressure (ASBP) Through 8 Weeks (time frame: Through 8 weeks). 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 NCT02392351, 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 11 Feb 2021.

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