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NCT06676553: INFORM

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

Recruiting now Phase 4 Last updated 6 November 2024
What this trial tests

Phase 4 trial testing Radiofrequency ablation alone, re-denervation to main and/or branch renal artery in Hypertension, Uncontrolled in 32 participants. Currently enrolling.

Timeline
14 October 2024
Primary endpoint
31 October 2026
30 June 2028

Quick facts

Lead sponsorNational Taiwan University Hospital
PhasePhase 4
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment32
Start date14 October 2024
Primary completion31 October 2026
Estimated completion30 June 2028
Sites1 location across Taiwan

Drugs / interventions tested

Conditions studied

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.

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Other National Taiwan University Hospital trials

Trials by the same sponsor.

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