NCT05421767

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4 hypertension

Timeline
17mo left

Started Jun 2022

Longer than P75 for phase_4 hypertension

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Jun 2022Dec 2027

First Submitted

Initial submission to the registry

April 24, 2020

Completed
2.1 years until next milestone

First Posted

Study publicly available on registry

June 16, 2022

Completed
8 days until next milestone

Study Start

First participant enrolled

June 24, 2022

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Expected
Last Updated

June 16, 2022

Status Verified

April 1, 2022

Enrollment Period

3.5 years

First QC Date

April 24, 2020

Last Update Submit

June 13, 2022

Conditions

Hypertension

Keywords

renal nerve stimulationrenal nerve denervationSympathetic nerve activity

Outcome Measures

Primary Outcomes (1)

  • arterial blood pressure response

    Main study parameter will be the arterial blood pressure response to RNS immediately after RDN.

    during procedure

Secondary Outcomes (2)

  • blood pressure at 6 months

    6 months after the intervention

  • blood pressure at 12 months

    12 months after the intervention

Study Arms (3)

Low RNS-induced SBP change group

ACTIVE COMPARATOR

25 patients with the RNS-induced systolic BP change \<20mmHg immediately after RDN

Procedure: nerve stimulation guided renal denervation procedure

High RNS-induced SBP change group

PLACEBO COMPARATOR

8 patients with the RNS-induced systolic BP change \>20mmHg immediately after RDN

Procedure: nerve stimulation guided renal denervation procedure

intensive RDN group

EXPERIMENTAL

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

Interventions

nerve stimulation guided renal denervation procedurePROCEDURE

RNS-in

Also known as: RNS-guided RDN
High RNS-induced SBP change groupLow RNS-induced SBP change groupintensive RDN group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with hypertension (HTN), including
  • hour ambulatory blood pressure \>130/ 80 mmHg
  • Age 20-80 years
  • Glomerular filtration rate \>45 mL/min

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

Related Publications (8)

  • Rodeheffer RJ. Hypertension and heart failure: the ALLHAT imperative. Circulation. 2011 Oct 25;124(17):1803-5. doi: 10.1161/CIRCULATIONAHA.111.059303. No abstract available.

    PMID: 22025634BACKGROUND

  • Bhatt DL, Kandzari DE, O'Neill WW, D'Agostino R, Flack JM, Katzen BT, Leon MB, Liu M, Mauri L, Negoita M, Cohen SA, Oparil S, Rocha-Singh K, Townsend RR, Bakris GL; SYMPLICITY HTN-3 Investigators. A controlled trial of renal denervation for resistant hypertension. N Engl J Med. 2014 Apr 10;370(15):1393-401. doi: 10.1056/NEJMoa1402670. Epub 2014 Mar 29.

    PMID: 24678939BACKGROUND

  • Townsend RR, Mahfoud F, Kandzari DE, Kario K, Pocock S, Weber MA, Ewen S, Tsioufis K, Tousoulis D, Sharp ASP, Watkinson AF, Schmieder RE, Schmid A, Choi JW, East C, Walton A, Hopper I, Cohen DL, Wilensky R, Lee DP, Ma A, Devireddy CM, Lea JP, Lurz PC, Fengler K, Davies J, Chapman N, Cohen SA, DeBruin V, Fahy M, Jones DE, Rothman M, Bohm M; SPYRAL HTN-OFF MED trial investigators*. Catheter-based renal denervation in patients with uncontrolled hypertension in the absence of antihypertensive medications (SPYRAL HTN-OFF MED): a randomised, sham-controlled, proof-of-concept trial. Lancet. 2017 Nov 11;390(10108):2160-2170. doi: 10.1016/S0140-6736(17)32281-X. Epub 2017 Aug 28.

    PMID: 28859944BACKGROUND

  • Kandzari DE, Bohm M, Mahfoud F, Townsend RR, Weber MA, Pocock S, Tsioufis K, Tousoulis D, Choi JW, East C, Brar S, Cohen SA, Fahy M, Pilcher G, Kario K; SPYRAL HTN-ON MED Trial Investigators. Effect of renal denervation on blood pressure in the presence of antihypertensive drugs: 6-month efficacy and safety results from the SPYRAL HTN-ON MED proof-of-concept randomised trial. Lancet. 2018 Jun 9;391(10137):2346-2355. doi: 10.1016/S0140-6736(18)30951-6. Epub 2018 May 23.

    PMID: 29803589BACKGROUND

  • Azizi M, Schmieder RE, Mahfoud F, Weber MA, Daemen J, Davies J, Basile J, Kirtane AJ, Wang Y, Lobo MD, Saxena M, Feyz L, Rader F, Lurz P, Sayer J, Sapoval M, Levy T, Sanghvi K, Abraham J, Sharp ASP, Fisher NDL, Bloch MJ, Reeve-Stoffer H, Coleman L, Mullin C, Mauri L; RADIANCE-HTN Investigators. Endovascular ultrasound renal denervation to treat hypertension (RADIANCE-HTN SOLO): a multicentre, international, single-blind, randomised, sham-controlled trial. Lancet. 2018 Jun 9;391(10137):2335-2345. doi: 10.1016/S0140-6736(18)31082-1. Epub 2018 May 23.

    PMID: 29803590BACKGROUND

  • Bohm M, Mahfoud F, Townsend RR, Kandzari DE, Pocock S, Ukena C, Weber MA, Hoshide S, Patel M, Tyson CC, Weil J, Agdirlioglu T, Fahy M, Kario K. Ambulatory heart rate reduction after catheter-based renal denervation in hypertensive patients not receiving anti-hypertensive medications: data from SPYRAL HTN-OFF MED, a randomized, sham-controlled, proof-of-concept trial. Eur Heart J. 2019 Mar 1;40(9):743-751. doi: 10.1093/eurheartj/ehy871.

    PMID: 30608521BACKGROUND

  • Liu H, Chen W, Lai Y, Du H, Wang Z, Xu Y, Ling Z, Fan J, Xiao P, Zhang B, Wang J, Gyawali L, Zrenner B, Woo K, Yin Y. Selective Renal Denervation Guided by Renal Nerve Stimulation in Canine. Hypertension. 2019 Sep;74(3):536-545. doi: 10.1161/HYPERTENSIONAHA.119.12680. Epub 2019 Jul 22.

    PMID: 31327262BACKGROUND

  • Gal P, de Jong MR, Smit JJ, Adiyaman A, Staessen JA, Elvan A. Blood pressure response to renal nerve stimulation in patients undergoing renal denervation: a feasibility study. J Hum Hypertens. 2015 May;29(5):292-5. doi: 10.1038/jhh.2014.91. Epub 2014 Oct 23.

    PMID: 25339295BACKGROUND

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
RNS guided RDN
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: RNS checked RDN
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2020

First Posted

June 16, 2022

Study Start

June 24, 2022

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2027

Last Updated

June 16, 2022

Record last verified: 2022-04

Locations

TW(1)