INtraprocedural Feedback-Optimized Renal Denervation Based on Measurements Obtained Through Renal Artery Stimulation: a Randomized Controlled Trial (INFORM)

NCT06676553 | Recruiting Phase 4 DMC

• 2 other identifiers: 202405100RIPEERP-2023-13518
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Hypertension, Uncontrolled; Hypertension, Resistant; Hypertension

Keywords

Hypertension; Renal denervation; Electric stimulation; Renal artery; Radiofrequency ablation

Outcome Measures

Primary Outcomes (1)

• 24-hour systolic blood pressure reduction (compared to baseline)

  6 months following the index renal denervation

Secondary Outcomes (3)

• 24-hour diastolic blood pressure reduction (compared to baseline)

  6 months following the index renal denervation

• Awake and asleep systolic/diastolic blood pressure and heart rate changes (compared to baseline)

  6 months following the index renal denervation

• Serum creatinine and estimated glomerular filtration rate changes

  6 months following the index renal denervation

Other Outcomes (2)

• 24-hour blood pressure changes based on branch artery constriction following renal artery stimulation

  6 months following the index renal denervation

• 24-hour blood pressure reduction (compared to baseline)

  1 year and 2 years following the index renal denervation

Study Arms (3)

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.

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.

Procedure: Radiofrequency ablation alone, no further renal denervation

Interventions

Radiofrequency ablation alone, re-denervation to main and/or branch renal artery DEVICE

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.

B: Re-denervation if renal artery stimulation-induced systolic blood pressure rise not suppressed

Radiofrequency ablation alone, no further renal denervation PROCEDURE

No further renal denervation after standard renal denervation even renal artery stimulation-induced systolic blood pressure rise \>= 20 mmHg

C: Control if renal artery stimulation-induced systolic blood pressure rise not suppressed

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• Smart Health Technology Research and Development Center, National Taiwan University: collaborator
• Medtronic: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, 100225, Taiwan

RECRUITING

Related Publications (1)

• 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.

  PMID: 36802802 RESULT

MeSH Terms

Conditions

Hypertension

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Tzung-Dau Wang, MD, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tzung-Dau Wang, MD, PhD

CONTACT

886-972651070; tdwang@ntu.edu.tw

Ya-Chun Chen, BS

CONTACT

886-2-23123456; yachun0411@gmai.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 6, 2024
• Study Start: October 14, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): June 30, 2028
• Last Updated: November 6, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR

Locations

TW (1)