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NCT06676553: INFORM
INtraprocedural Feedback-Optimized Renal Denervation Based on Measurements Obtained Through Renal Artery Stimulation: a Randomized Controlled Trial (INFORM)
Phase 4 trial testing Radiofrequency ablation alone, re-denervation to main and/or branch renal artery in Hypertension, Uncontrolled in 32 participants. Currently enrolling.
31 October 2026
Quick facts
| Lead sponsor | National Taiwan University Hospital |
|---|---|
| Phase | Phase 4 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 32 |
| Start date | 14 October 2024 |
| Primary completion | 31 October 2026 |
| Estimated completion | 30 June 2028 |
| Sites | 1 location across Taiwan |
Drugs / interventions tested
- Radiofrequency ablation alone, re-denervation to main and/or branch renal artery
- Radiofrequency ablation alone, no further renal denervation
Conditions studied
- Hypertension, Uncontrolled — all drugs for Hypertension, Uncontrolled →
- Hypertension, Resistant — all drugs for Hypertension, Resistant →
- Hypertension — all drugs for Hypertension →
Sponsor
National Taiwan University Hospital
Who can join
18 and older, any sex, with Hypertension, Uncontrolled or Hypertension, Resistant. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06676553
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06676553 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Taiwan University Hospital
- Last refreshed: 6 November 2024
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