HypertensionPhase 4RNDNCT05421767
Renal Nerve Stimulation in Uncontrolled Hypertensive Patients Undergoing Renal Denervation
A Phase 4 study testing nerve stimulation guided renal denervation procedure in people with Hypertension, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- nerve stimulation guided renal denervation procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 Jun 2022to 31 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with hypertension (HTN), including
- 24-hour ambulatory blood pressure >130/ 80 mmHg
- Age 20-80 years
- Glomerular filtration rate >45 mL/min
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Hui-Chun Huang, M.D, 886-23123456 ext. 62152, hchuangster@ntuh.gov.tw
Tzung-Dau Wang, PHD, 886-23123456 ext. 62152, tdwang@ntu.edu.tw
About this study
Official title: National Tawan University Hospital
Study design: Investigator initiated, single center The study is aimed
- To investigate the blood pressure (BP) change to renal nerve stimulation(RNS), and subsequently perform a renal denervation(RDN) procedure
- 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.
Read the 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
- to investigate the BP change to RNS, and subsequently perform a RDN procedure
- 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.
- 24-hour ambulatory blood pressure monitoring (ABPM) was >130 or DBP >80 mmHg
Exclusion criteria:
- Unsuitable renal artery anatomy (main renal artery lumen diameter ≤3 mm or a total length <20 mm of the main arteries).
- Secondary hypertension, including hyperaldosteronism, pheochromocytoma, renal artery stenosis(>50% stenosis in one or both arteries)
- Pregnancy
Intervention:
RNS-guided RDN will be performed
- Group A (N=35): RNS-induced SBP increase of <20 mmHg in bilateral proximal main renal arteries immediately after RDN
- 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.
- Conditions
- Hypertension
- Being tested
- nerve stimulation guided renal denervation procedure
- Keywords
- renal nerve stimulation, renal nerve denervation, Sympathetic nerve activity
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nerve stimulation guided renal denervation procedureProcedure or surgery
Also called RNS-guided RDN
RNS-in
| Study group | Role | What they receive |
|---|---|---|
| Low RNS-induced SBP change group | Active comparator | 25 patients with the RNS-induced systolic BP change <20mmHg immediately after RDN Receives: 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 Receives: 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 Receives: Procedure: nerve stimulation guided renal denervation procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
arterial blood pressure response
Main study parameter will be the arterial blood pressure response to RNS immediately after RDN.
Measured: during procedure
Secondary outcomes (2)
blood pressure at 6 months
24 hours Blood pressure at 6 months after the intervention
Measured: 6 months after the intervention
blood pressure at 12 months
24 hours Blood pressure at 12 months after the intervention
Measured: 12 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start24 Jun 2022 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- RNS checked RDN
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05421767
- Sponsor's protocol ID
- 201902040RINC
- Acronym
- RND
- Status last verified
- Apr 2022
- First submitted
- 24 Apr 2020
- Last updated
- 16 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 22025634Bhatt 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.
PubMed 24678939Townsend 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.
PubMed 28859944Kandzari 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.
PubMed 29803589Azizi 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.
PubMed 29803590Bohm 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.
PubMed 30608521Liu 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.
PubMed 31327262Gal 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.
PubMed 25339295
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Tawan University Hospital
- ClinicalTrials.gov ID
- NCT05421767
- Acronym / sponsor ID
- RND / 201902040RINC
- Conditions
- Hypertension
- Keywords
- renal nerve stimulation, renal nerve denervation, Sympathetic nerve activity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 24 Jun 2022 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 16 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study design: Investigator initiated, single center The study is aimed
- To investigate the blood pressure (BP) change to renal nerve stimulation(RNS), and subsequently perform a renal denervation(RDN) procedure
- 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.
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
- to investigate the BP change to RNS, and subsequently perform a RDN procedure
- 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.
- 24-hour ambulatory blood pressure monitoring (ABPM) was >130 or DBP >80 mmHg
Exclusion criteria:
- Unsuitable renal artery anatomy (main renal artery lumen diameter ≤3 mm or a total length <20 mm of the main arteries).
- Secondary hypertension, including hyperaldosteronism, pheochromocytoma, renal artery stenosis(>50% stenosis in one or both arteries)
- Pregnancy
Intervention:
RNS-guided RDN will be performed
- Group A (N=35): RNS-induced SBP increase of <20 mmHg in bilateral proximal main renal arteries immediately after RDN
- 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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- RNS checked RDN
| Arm | Type | Receives |
|---|---|---|
| Low RNS-induced SBP change group | Active comparator | Procedure: nerve stimulation guided renal denervation procedure25 patients with the RNS-induced systolic BP change <20mmHg immediately after RDN |
| High RNS-induced SBP change group | Placebo comparator | Procedure: nerve stimulation guided renal denervation procedure8 patients with the RNS-induced systolic BP change >20mmHg immediately after RDN |
| intensive RDN group | Experimental | Procedure: nerve stimulation guided renal denervation procedure17 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 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with hypertension (HTN), including
- 24-hour ambulatory blood pressure >130/ 80 mmHg
- Age 20-80 years
- Glomerular filtration rate >45 mL/min
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nerve stimulation guided renal denervation procedureAlso: RNS-guided RDNRNS-in | Procedure or surgery | High RNS-induced SBP change group, Low RNS-induced SBP change group, intensive RDN group |
Primary outcome
arterial blood pressure response
Time frame: during procedure
Main study parameter will be the arterial blood pressure response to RNS immediately after RDN.
2 secondary outcomes
blood pressure at 6 months
Time frame: 6 months after the intervention
blood pressure at 12 months
Time frame: 12 months after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2022.
- Background: PubMed 22025634Rodeheffer 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.
- Background: PubMed 24678939Bhatt 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.
- Background: PubMed 28859944Townsend 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.
- Background: PubMed 29803589Kandzari 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.
- Background: PubMed 29803590Azizi 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.
- Background: PubMed 30608521Bohm 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.
- Background: PubMed 31327262Liu 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.
- Background: PubMed 25339295Gal 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing nerve stimulation guided renal denervation procedure in people with Hypertension, run by National Taiwan University Hospital at 1 site in Taiwan.
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 4 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 16 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
arterial blood pressure response (time frame: during procedure). 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 NCT05421767, which also lists 8 linked publications.
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 16 Jun 2022.