RDN Fesibility Study

February 15, 2023 updated by: Gormin Tan, Chinese University of Hong Kong

Renal Nerve Simulation Guided Renal Sympathetic Denervation With Siymplicity Spyral Radiofrequency Catheter for Resistant Hypertension: a Feasibility Study.

Renal sympathetic denervation (RDN) was considered an effective alternative for patients whose blood pressure (BP) is not optimally controlled. The RDN works mainly by selectively disabling the nerves around the renal arteries and reducing blood pressure increase. However, despite the early success showed in the SYMPLICITY HTN-2 trial, the SYMPLICITY HTN-3 trial failed to demonstrate a significant BP reduction when compared to sham-control. incomplete disabling might result in inadequate denervation and were cited as some of the contributors to the nil result in the SYMPLICITY HTN-3 . The new generation of the Symplicity Spyral catheter aims to address some of these issues by altering the configuration of the catheter to allow better apposition to the renal arterial wall and increasing the numbers of electrodes to faciiitate more thorough ablations. However, the adequacy of sympathetic denervation with this new catheter can not be easily assessed at the time of the procedure as there is no simple physiological or biochemical feedbacks that can be monitored during the procedure. Blood pressure response by renal nerve simulation (RNS) during RDN procedure using the previous generation of the Symplicity Flex catheter have been reported to be potential parameter to assess the efficacy during the procedure and predict the BP response 6 months after RDN. The feasibility of RNS guided RDN procedure using the new generation of Symplicity Spyral catheter has not been reported. We therefore aim to explore the feasibility of RNS guided RDN with Symplicity Spyral Radiofrequency Catheter in patient with resistant hypertension.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Renal sympathetic denervation (RDN) was considered an effective alternative for patients whose blood pressure (BP) is not optimally controlled. The RDN works mainly by selectively disabling the nerves around the renal arteries and reducing blood pressure increase. However, despite the early success showed in the SYMPLICITY HTN-2 trial, the SYMPLICITY HTN-3 trial failed to demonstrate a significant BP reduction when compared to sham-control. incomplete disabling might result in inadequate denervation and were cited as some of the contributors to the nil result in the SYMPLICITY HTN-3 . The new generation of the Symplicity Spyral catheter aims to address some of these issues by altering the configuration of the catheter to allow better apposition to the renal arterial wall and increasing the numbers of electrodes to faciiitate more thorough ablations. However, the adequacy of sympathetic denervation with this new catheter can not be easily assessed at the time of the procedure as there is no simple physiological or biochemical feedbacks that can be monitored during the procedure. Blood pressure response by renal nerve simulation (RNS) during RDN procedure using the previous generation of the Symplicity Flex catheter have been reported to be potential parameter to assess the efficacy during the procedure and predict the BP response 6 months after RDN. The feasibility of RNS guided RDN procedure using the new generation of Symplicity Spyral catheter has not been reported. We therefore aim to explore the feasibility of RNS guided RDN with Symplicity Spyral Radiofrequency Catheter in patient with resistant hypertension.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
    • Shatin
      • Hong Kong, Shatin, Hong Kong, 0000
        • Recruiting
        • Prince of Wales Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This is a feasibility study, small sample size serves as a proof of concept

Description

Inclusion Criteria:

  1. Age > 18 years
  2. With resistant hypertension as defined by systolic BP over 140 mmHg on 24 hours ambulatory blood pressure measurement (ABPM)
  3. Already on a stable dose of at least 3 anti-hypertensive drugs of different classes for 3 months.
  4. subject is recruited for Transcatheter Renal Denervation

Exclusion Criteria:

  1. Individual has undergone prior renal denervation.
  2. Presence of renal artery stenosis >50%.
  3. Main renal artery diameter <3mm and larger than 8mm by visual assessment on angiography.
  4. Previous renal stenting.
  5. Subject with Estimated GFR <30ml/min/1.73m2 as calculated using the MDRD formula.
  6. Subject with renal transplant, single kidney, active nephritis or polycystic kidney disease.
  7. Subject with known pheochromocytoma, Cushing's Syndrome (hypercortisolism), primary hyperaldosteronism, coarctation of the aorta, untreated hyperthyroidism, untreated hypothyroidism, or primary hyperparathyroidism.
  8. Subject with unstable cardiac conditions such as myocardial infarction, unstable angina, malignant arrythmia, pulmonary embolism, significant valvular condition awaiting surgery or recent cerebrovascular accident within 3 months of recruitment.
  9. Subject who is pregnant or planning for pregnancy during the study duration.
  10. Subject who is enrolled in another device study for renal sympathetic denervation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
the difference of RNS BP response before and after RDN
Time Frame: 24-hrs
24-hrs

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
the changes in 24-hour ABPM after RDN
Time Frame: 6 months
6 months
the change in office BP measurement;
Time Frame: 6 months
6 months
the change in the number and dosage of anti-hypertensives
Time Frame: 6 months
6 months
the change in renal function as measured by estimated GFR
Time Frame: 6 months
6 months
the change in renal function as measured by ratio urine albumin-creatinine
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 21, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 2, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 24, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 24, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022.391

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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