Hypertension, UncontrolledPhase 4INFORMNCT06676553
INtraprocedural Feedback-Optimized Renal Denervation Based on Measurements Obtained Through Renal Artery Stimulation: a Randomized Controlled Trial (INFORM)
A Phase 4 study testing Radiofrequency ablation alone, re-denervation to main and/or branch renal artery and Radiofrequency ablation alone, no further renal denervation in people with Hypertension, Uncontrolled and Hypertension, Resistant, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Our previous study (Huang HC, Pan HY, Wang TD, Circ Cardiovasc Interv 2023;16:e012779) demonstrated that when renal artery stimulation continues to trigger systolic blood pressure increases (>=20 mmHg increase compared to baseline) after the initial procedure, patients show poor blood pressure reduction 6 months… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Uncontrolled, Hypertension, Resistant, Hypertension
- What is being tested?
- Radiofrequency ablation alone, re-denervation to main and/or branch renal artery and Radiofrequency ablation alone, no further renal denervation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteTaiwan
- Study dates
- 14 Oct 2024to 30 Jun 2028
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with hypertension and are willing to undergo renal denervation.
- Patients are treated with antihypertensive medications, or with an office systolic blood pressure (SBP) >140 mm Hg or diastolic blood pressure (DBP) >90 mm Hg, and 24-hour SBP of >130 mmHg or DBP >80 mm Hg, irrespective of antihypertensive treatment.
Who cannot join
- An unsuitable renal artery anatomy for renal denervation, assessed by computed tomographic angiography (main renal artery lumen diameter <3 mm or a total length <20 mm).
- Secondary hypertension, including hyperaldosteronism, pheochromocytoma, and renal artery stenosis (>50% stenosis in one or both arteries).
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, 100225
Tzung-Dau Wang, MD, PhD, 886-972651070, tdwang@ntu.edu.tw
Tzung-Dau Wang, MD, PhD
About this study
Official title: INtraprocedural Feedback-Optimized Renal Denervation Based on Measurements Obtained Through Renal Artery Stimulation: a Randomized Controlled Proof-of-concept Trial to Assess Whether Renal Denervation Guided by Renal Artery Stimulation Outperforms Conventional Renal Denervation in 6-month Ambulatory Blood Pressure Reductions
Our previous study (Huang HC, Pan HY, Wang TD, Circ Cardiovasc Interv 2023;16:e012779) demonstrated that when renal artery stimulation continues to trigger systolic blood pressure increases (>=20 mmHg increase compared to baseline) after the initial procedure, patients show poor blood pressure reduction 6 months following renal denervation. Based on this finding, we designed a proof-of-concept trial comparing two approaches: a guided strategy versus conventional renal denervation. In the guided strategy, we perform additional ablations of main and/or branch renal arteries if immediate post-procedure stimulation still elevates systolic blood pressure (>=20 mmHg increase compared to baseline). The conventional approach involves no repeat procedures. This trial aims to determine whether the guided strategy leads to better clinical outcomes, measured by 6-month ambulatory blood pressure changes, and to establish the value of using intraprocedural feedback to assess and guide renal denervation treatment.
Read the detailed description
- Anesthesia: Intravenous propofol to achieve adequate sedation throughout the course.
- Renal artery stimulation (RAS) will be performed at 2 sites (proximal and distal main renal artery) in both renal arteries. Pacing frequency was set at 10 Hz, pacing output at 20 mA with a pulse duration of 10 ms, and duration of 60 sec based on earlier researches. The maximal systolic blood pressure rise and branch renal artery constriction since the start of RAS till 3 minutes after its discontinuation will be recorded. The body reaction during RAS will be recorded (0, no response; 1, mild (voice) response; 2. limited movement; 3. significant movement).
- Renal denervation (RDN) will be performed using the multielectrode Symplicity Spyral RDN catheter. The multielectrode RDN catheter contains 4 electrodes separated from each other in a spiral configuration. Up to 4 discrete radiofrequency (RF) ablations were applied simultaneously. Each application lasts ≤60 s with a power ≤8 Watts (W) and a target temperature of ≤70°C (158°F). Electrodes that do not reach the therapeutic temperature or impedance drop are automatically switched off.
- Post RDN renal artery stimulation:
After RDN completed, renal artery stimulation will be repeated immediately. The maximal RAS-induced SBP changes will be recorded. All BP readings are the average of 8 consecutive beats by default (Siemens, Germany), which could minimize the inadvertent BP fluctuations by movements and respiration (8 beats could encompass at least one respiratory cycle). The branch renal artery constriction since the start of RAS till 3 minutes after its discontinuation will be recorded. The body reaction during RAS will be recorded (0, no response; 1, mild (voice) response; 2. limited movement; 3. significant movement).
- Being tested
- Radiofrequency ablation alone, re-denervation to main and/or branch renal artery, Radiofrequency ablation alone, no further renal denervation
- Keywords
- Hypertension, Renal denervation, Electric stimulation, Renal artery, Radiofrequency ablation
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablation alone, re-denervation to main and/or branch renal arteryDevice
Re-denervation according to the site where renal artery stimulation can induce systolic blood pressure rise of >= 20 mmHg. Main renal artery denervation if proximal main renal artery stimulation positive, while branch renal artery denervation if distal main renal artery stimulation positive.
Radiofrequency ablation alone, no further renal denervationProcedure or surgery
No further renal denervation after standard renal denervation even renal artery stimulation-induced systolic blood pressure rise >= 20 mmHg
| Study group | Role | What they receive |
|---|---|---|
| A: Renal artery stimulation-induced systolic blood pressure rise suppressed (<20 mmHg) | No intervention | No further renal denervation after standard renal denervation procedure |
| B: Re-denervation if renal artery stimulation-induced systolic blood pressure rise not suppressed | Active comparator | Another round of renal denervation (main renal artery for positive proximal stimulation; branch artery for positive distal stimulation) after standard renal denervation. The definition of non-suppressed is systolic blood pressure rise >=20 mmHg compared to baseline. Receives: Device: Radiofrequency ablation alone, re-denervation to main and/or branch renal artery |
| C: Control if renal artery stimulation-induced systolic blood pressure rise not suppressed | Placebo comparator | No further renal denervation after standard renal denervation. The definition of non-suppressed is systolic blood pressure rise >=20 mmHg compared to baseline. Receives: Procedure: Radiofrequency ablation alone, no further renal denervation |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour systolic blood pressure reduction (compared to baseline)
Measured: 6 months following the index renal denervation
Secondary outcomes (3)
24-hour diastolic blood pressure reduction (compared to baseline)
Measured: 6 months following the index renal denervation
Awake and asleep systolic/diastolic blood pressure and heart rate changes (compared to baseline)
Measured: 6 months following the index renal denervation
Serum creatinine and estimated glomerular filtration rate changes
Measured: 6 months following the index renal denervation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start14 Oct 2024
- Primary completion31 Oct 2026 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypertension, UncontrolledStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Smart Health Technology Research and Development Center, National Taiwan University, Medtronic
- Responsible party
- Sponsor
- Investigators
- Tzung-Dau Wang, MD, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06676553
- Sponsor's protocol ID
- 202405100RIPE
- Other IDs
- ERP-2023-13518
- Acronym
- INFORM
- Status last verified
- Nov 2024
- First submitted
- 4 Nov 2024
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Under reasonable request and approved by the principle investigator, the information could be shared.
Publications
Huang HC, Pan HY, Wang TD. Renal Nerve Stimulation Predicted Blood Pressure-Lowering Responses to Percutaneous Renal Denervation. Circ Cardiovasc Interv. 2023 Feb;16(2):e012779. doi: 10.1161/CIRCINTERVENTIONS.122.012779. Epub 2023 Feb 21. No abstract available.
PubMed 36802802
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INtraprocedural Feedback-Optimized Renal Denervation Based on Measurements Obtained Through Renal Artery Stimulation: a Randomized Controlled Proof-of-concept Trial to Assess Whether Renal Denervation Guided by Renal Artery Stimulation Outperforms Conventional Renal Denervation in 6-month Ambulatory Blood Pressure Reductions
- ClinicalTrials.gov ID
- NCT06676553
- Acronym / sponsor ID
- INFORM / 202405100RIPE
- Keywords
- Hypertension, Renal denervation, Electric stimulation, Renal artery, Radiofrequency ablation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Smart Health Technology Research and Development Center, National Taiwan University, Medtronic
- Study start
- 14 Oct 2024 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 6 Nov 2024 (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.
Our previous study (Huang HC, Pan HY, Wang TD, Circ Cardiovasc Interv 2023;16:e012779) demonstrated that when renal artery stimulation continues to trigger systolic blood pressure increases (>=20 mmHg increase compared to baseline) after the initial procedure, patients show poor blood pressure reduction 6 months following renal denervation. Based on this finding, we designed a proof-of-concept trial comparing two approaches: a guided strategy versus conventional renal denervation. In the guided strategy, we perform additional ablations of main and/or branch renal arteries if immediate post-procedure stimulation still elevates systolic blood pressure (>=20 mmHg increase compared to baseline). The conventional approach involves no repeat procedures. This trial aims to determine whether the guided strategy leads to better clinical outcomes, measured by 6-month ambulatory blood pressure changes, and to establish the value of using intraprocedural feedback to assess and guide renal denervation treatment.
Detailed description
- Anesthesia: Intravenous propofol to achieve adequate sedation throughout the course.
- Renal artery stimulation (RAS) will be performed at 2 sites (proximal and distal main renal artery) in both renal arteries. Pacing frequency was set at 10 Hz, pacing output at 20 mA with a pulse duration of 10 ms, and duration of 60 sec based on earlier researches. The maximal systolic blood pressure rise and branch renal artery constriction since the start of RAS till 3 minutes after its discontinuation will be recorded. The body reaction during RAS will be recorded (0, no response; 1, mild (voice) response; 2. limited movement; 3. significant movement).
- Renal denervation (RDN) will be performed using the multielectrode Symplicity Spyral RDN catheter. The multielectrode RDN catheter contains 4 electrodes separated from each other in a spiral configuration. Up to 4 discrete radiofrequency (RF) ablations were applied simultaneously. Each application lasts ≤60 s with a power ≤8 Watts (W) and a target temperature of ≤70°C (158°F). Electrodes that do not reach the therapeutic temperature or impedance drop are automatically switched off.
- Post RDN renal artery stimulation:
After RDN completed, renal artery stimulation will be repeated immediately. The maximal RAS-induced SBP changes will be recorded. All BP readings are the average of 8 consecutive beats by default (Siemens, Germany), which could minimize the inadvertent BP fluctuations by movements and respiration (8 beats could encompass at least one respiratory cycle). The branch renal artery constriction since the start of RAS till 3 minutes after its discontinuation will be recorded. The body reaction during RAS will be recorded (0, no response; 1, mild (voice) response; 2. limited movement; 3. significant movement).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A: Renal artery stimulation-induced systolic blood pressure rise suppressed (<20 mmHg) | No intervention | –No further renal denervation after standard renal denervation procedure |
| B: Re-denervation if renal artery stimulation-induced systolic blood pressure rise not suppressed | Active comparator | Device: Radiofrequency ablation alone, re-denervation to main and/or branch renal arteryAnother round of renal denervation (main renal artery for positive proximal stimulation; branch artery for positive distal stimulation) after standard renal denervation. The definition of non-suppressed is systolic blood pressure rise >=20 mmHg compared to baseline. |
| C: Control if renal artery stimulation-induced systolic blood pressure rise not suppressed | Placebo comparator | Procedure: Radiofrequency ablation alone, no further renal denervationNo further renal denervation after standard renal denervation. The definition of non-suppressed is systolic blood pressure rise >=20 mmHg compared to baseline. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with hypertension and are willing to undergo renal denervation.
- Patients are treated with antihypertensive medications, or with an office systolic blood pressure (SBP) >140 mm Hg or diastolic blood pressure (DBP) >90 mm Hg, and 24-hour SBP of >130 mmHg or DBP >80 mm Hg, irrespective of antihypertensive treatment.
Key exclusion criteria (2 listed)
- An unsuitable renal artery anatomy for renal denervation, assessed by computed tomographic angiography (main renal artery lumen diameter <3 mm or a total length <20 mm).
- Secondary hypertension, including hyperaldosteronism, pheochromocytoma, and renal artery stenosis (>50% stenosis in one or both arteries).
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 |
|---|---|---|
| Radiofrequency ablation alone, re-denervation to main and/or branch renal arteryRe-denervation according to the site where renal artery stimulation can induce systolic blood pressure rise of >= 20 mmHg. Main renal artery denervation if proximal main renal artery stimulation positive, while branch renal artery denervation if distal main renal artery stimulation positive. | Device | B: Re-denervation if renal artery stimulation-induced systolic blood pressure rise not suppressed |
| Radiofrequency ablation alone, no further renal denervationNo further renal denervation after standard renal denervation even renal artery stimulation-induced systolic blood pressure rise >= 20 mmHg | Procedure or surgery | C: Control if renal artery stimulation-induced systolic blood pressure rise not suppressed |
Primary outcome
24-hour systolic blood pressure reduction (compared to baseline)
Time frame: 6 months following the index renal denervation
3 secondary outcomes
24-hour diastolic blood pressure reduction (compared to baseline)
Time frame: 6 months following the index renal denervation
Awake and asleep systolic/diastolic blood pressure and heart rate changes (compared to baseline)
Time frame: 6 months following the index renal denervation
Serum creatinine and estimated glomerular filtration rate changes
Time frame: 6 months following the index renal denervation
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 6 Nov 2024.
- Results publication: PubMed 36802802Huang HC, Pan HY, Wang TD. Renal Nerve Stimulation Predicted Blood Pressure-Lowering Responses to Percutaneous Renal Denervation. Circ Cardiovasc Interv. 2023 Feb;16(2):e012779. doi: 10.1161/CIRCINTERVENTIONS.122.012779. Epub 2023 Feb 21. No abstract available.
- Individual participant dataSharing planned: Yes. Under reasonable request and approved by the principle investigator, the information could be shared.
Related trials for Hypertension, Uncontrolled
Recruiting
Effectiveness and Cost-Effectiveness of a Digital Care Pathway and Asynchronous Communication for Patients With Hypertension
Hypertension
RecruitingPhase 2/3
A Trial of HRS-1780 in Participants With Uncontrolled Hypertension or Resistant Hypertension.
Uncontrolled or Resistant Hypertension
Recruiting
SPYRAL GEMINI Pilot Study
Hypertension, Vascular Diseases
Active, not recruiting
SPYRAL AFFIRM Global Study of RDN With the Symplicity Spyral RDN System in Subjects With Uncontrolled HTN
Hypertension, Vascular Diseases
RecruitingObservational study
Global Paradise System US Post Approval Study
Hypertension, Cardiovascular Diseases
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.
Tzung-Dau Wang, MD, PhD principal investigator
National Taiwan University Hospital
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 Radiofrequency ablation alone, re-denervation to main and/or branch renal artery and Radiofrequency ablation alone, no further renal denervation in people with Hypertension, Uncontrolled and Hypertension, Resistant, 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 2 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 6 Nov 2024. 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?
Contact Tzung-Dau Wang, MD, PhD (886-972651070, tdwang@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24-hour systolic blood pressure reduction (compared to baseline) (time frame: 6 months following the index renal denervation). 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 NCT06676553, 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 6 Nov 2024.