Renal Nerve Stimulation in Uncontrolled Hypertensive Patients Undergoing Renal Denervation (RND)

June 13, 2022 updated by: National Taiwan University Hospital

National Tawan University Hospital

Study design: Investigator initiated, single center The study is aimed

1) To investigate the blood pressure (BP) change to renal nerve stimulation(RNS), and subsequently perform a renal denervation(RDN) procedure

1) to verify the cutoff value (RNS-induced systolic BP change <20 mmHg in post-RDN patients) could be a useful clinical endpoint in RDN therapy, and test the hypothesis that intense RDN could improve the efficacy of RDN.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Hypertension has become a global public health concern and associated with considerable risk of cardiovascular, cerebrovascular and kidney diseases. Although pharmacological blood pressure (BP) control can reduce these risks, BP control rates remain suboptimal. Resistant hypertension affects 10% to 15% of patients with hypertension and adequate BP control is associated with better clinical outcome of resistant hypertension. Percutaneous renal denervation system (RDN) is designed to disrupt renal afferent and efferent sympathetic nerves to modulate central sympathetic outflow and renal physiology, achieving sustained BP reduction. Although the randomized, sham-controlled trial, SYMPLICITY HTN-3 in 2014, failed to prove the effectiveness of RDN in reducing BP compared to sham procedure, three carefully designed, randomized sham-controlled RDN trials (SPYRAL HTN-OFF MED, SPYRAL HTN-ON MED, and RADIANCE-HTN SOLO), all of which showed similar and clinically meaningful BP reductions without serious adverse events. RDN, therefore, has been approved and well utilized in clinical practice to treat resistant hypertension. However,15-30% of the patients are non-responders. The reason for this is unknown. Experimental data show that renal nerve stimulation (RNS) may serve as a functional endpoint to assess completeness of the RDN procedure. Our preliminary observation study showed low RNS-induced SBP change in post-RDN patients were associated with better BP lowering response.

Our study objectives are

1) to investigate the BP change to RNS, and subsequently perform a RDN procedure

1) to verify the cutoff value (RNS-induced systolic BP change <20mmHg in post-RDN patients) could be a useful clinical endpoint in RDN therapy.

Hypotheses:

We hypothesize that an RNS-induced SBP increase of <20 mmHg in bilateral proximal main renal arteries immediately after RDN was associated with significant BP reductions 6 months following RDN. RNS-induced SBP changes could predict RDN response and even guide RDN strategies

Study design: Investigator initiated, single center, prospective study Patient population: 60 patients (20 - 80 years old) Patients with HTN.

1) 24-hour ambulatory blood pressure monitoring (ABPM) was >130 or DBP >80 mmHg

Exclusion criteria:

  1. Unsuitable renal artery anatomy (main renal artery lumen diameter ≤3 mm or a total length <20 mm of the main arteries).
  2. Secondary hypertension, including hyperaldosteronism, pheochromocytoma, renal artery stenosis(>50% stenosis in one or both arteries)
  3. Pregnancy

Intervention:

RNS-guided RDN will be performed

  1. Group A (N=35): RNS-induced SBP increase of <20 mmHg in bilateral proximal main renal arteries immediately after RDN
  2. Group B(N=25): RNS-induced SBP increase of >20 mmHg in bilateral proximal main renal arteries immediately after RDN Then we will further divided Group B into Group C (N=8): observation group Group D(N=17): intensive intervention group (intensive -RDN again and the goal was post RNS-induced SBP change <20 mmHg)

Primary end-points:

The primary end points were the low RNS-induced systolic BP changes after RDN, was associated with the lower 24-hour SBP.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

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

  • Taiwan
      • Taipei, Taiwan, 100
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
        • 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

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients with hypertension (HTN), including

  1. 24-hour ambulatory blood pressure >130/ 80 mmHg
  2. Age 20-80 years
  3. Glomerular filtration rate >45 mL/min

Exclusion Criteria:

  1. Unsuitable renal artery anatomy computed tomographic angiography (main renal artery lumen diameter ≤3 mm or a total length <20 mm of the main arteries).
  2. untreated secondary HTN, including hyperaldosteronism, pheochromocytoma, renal artery stenosis(>50% stenosis)

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

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Low RNS-induced SBP change group
25 patients with the RNS-induced systolic BP change <20mmHg immediately after RDN
Procedure: nerve stimulation guided renal denervation procedure
RNS-in
Other Names:
  • RNS-guided RDN
Placebo Comparator: High RNS-induced SBP change group
8 patients with the RNS-induced systolic BP change >20mmHg immediately after RDN
Procedure: nerve stimulation guided renal denervation procedure
RNS-in
Other Names:
  • RNS-guided RDN
Experimental: intensive RDN group
17 patients with the initial RNS-induced systolic BP change >20mmHg immediately after RDN, received intensive RDN therapy and let the second RNS-induced systolic BP change < 20mmHg
Procedure: nerve stimulation guided renal denervation procedure
RNS-in
Other Names:
  • RNS-guided RDN

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
arterial blood pressure response
Time Frame: during procedure
Main study parameter will be the arterial blood pressure response to RNS immediately after RDN.
during procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood pressure at 6 months
Time Frame: 6 months after the intervention
24 hours Blood pressure at 6 months after the intervention
6 months after the intervention
blood pressure at 12 months
Time Frame: 12 months after the intervention
24 hours Blood pressure at 12 months after the intervention
12 months after the intervention

Collaborators and Investigators

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

Sponsor

National Taiwan University Hospital

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 (Anticipated)

June 24, 2022

Primary Completion (Anticipated)

December 31, 2025

Study Completion (Anticipated)

December 31, 2027

Study Registration Dates

First Submitted

April 24, 2020

First Submitted That Met QC Criteria

June 13, 2022

First Posted (Actual)

June 16, 2022

Study Record Updates

Last Update Posted (Actual)

June 16, 2022

Last Update Submitted That Met QC Criteria

June 13, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201902040RINC

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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