Pulnovo's pulmonary artery denervation trial closes enrollment, no data yet
The Phase 3 PADN-HF-PH trial moved to Active, not recruiting after its primary completion date shifted to August 27, 2025, with the clinical-worsening readout still pending.
Executive Summary
- A Phase 3 registrational trial testing a catheter-based denervation procedure for pulmonary hypertension linked to left heart failure closed enrollment and moved to Active, not recruiting.
- The trial tests whether adding a one-time procedural intervention to standard heart failure drug therapy reduces clinical worsening, in a pulmonary hypertension subtype where no procedural therapy is approved.
- The completion-date shifts and enrollment change sit within the routine range for a trial of this design and phase, and the transition to non-recruiting status follows naturally from enrollment closing on target.
- No other Phase 3 program tests a denervation procedure against guideline-directed drug therapy in this population, leaving the composite clinical-worsening endpoint as the first test of whether the mechanism adds benefit.
The status change
Pulnovo Medical's registry record for NCT05824923 shows the trial moved from Recruiting to Active, not recruiting, with the primary completion date updated to August 27, 2025, from a prior estimate of August 1, 2025. The trial randomizes patients 1:1 to pulmonary artery denervation plus guideline-directed medical therapy or guideline-directed medical therapy alone, with a target enrollment of 264 patients across sites in China. No results have posted to ClinicalTrials.gov for this study. NCT05824923A Trial to Evaluate the Safety and Efficacy of Pulmonary Artery Denervation for the Treatment of Pulmonary Hypertension Associated With Left Heart FailureNCT05824923
Probability of SuccessBased on the AppliedXL Probability of Success model. For more information about the methodology, read the research here.
What the trial tests
The primary endpoint is a composite of clinical worsening: need for intravenous heart failure medication, rehospitalization for heart failure, a six-minute walk distance decline of more than 10% or 30 meters from baseline, referral for heart or heart-lung transplant, or all-cause death, measured from randomization until the last enrolled patient completes at least six months of follow-up. Enrolled patients carry six-minute walk distances between 100 and 450 meters, elevated NT-proBNP, and hemodynamic markers of pulmonary hypertension confirmed by right heart catheterization, a population selected to isolate patients with pulmonary hypertension secondary to left heart failure rather than other pulmonary hypertension subtypes. Secondary measures include echocardiographic changes, quality-of-life scores on the Kansas City Cardiomyopathy Questionnaire, and NT-proBNP trends tracked out to three years. NCT05824923A Trial to Evaluate the Safety and Efficacy of Pulmonary Artery Denervation for the Treatment of Pulmonary Hypertension Associated With Left Heart FailureNCT05824923
The operational picture
The primary completion date has moved three times since the trial's 2023 registration, from December 2024 to February 2025, then to August 2025, and now to August 27, 2025, alongside a modest reduction in target enrollment from 276 to 264 patients. That enrollment change falls within the routine range for a Phase 3 trial of this design, an operational risk model that flags changes at 20% or more found the 4.3% shift typical rather than a signal of distress. The status move to Active, not recruiting follows directly from enrollment closing at its target, consistent with a trial reaching its planned recruitment endpoint rather than stalling. NCT05824923A Trial to Evaluate the Safety and Efficacy of Pulmonary Artery Denervation for the Treatment of Pulmonary Hypertension Associated With Left Heart FailureNCT05824923
The competitive landscape
No Phase 3 trial identified in the pulmonary hypertension field tests a denervation procedure against guideline-directed drug therapy as a direct comparator; the closest procedural analogs are earlier-stage denervation programs from Gradient Denervation Technologies testing a different device system in the same pulmonary hypertension Group 2 population. The broader pulmonary hypertension field is populated mainly by drug candidates, sotatercept and treprostinil among the most active programs by trial count and enrollment, none of which compete directly with a procedural approach. Approved drug therapies for pulmonary hypertension, including riociguat and treprostinil, treat World Health Organization Group 1 or Group 4 disease rather than the Group 2, left-heart-failure-associated pulmonary hypertension this trial targets, leaving the procedure to compete against guideline-directed medical therapy itself rather than an approved procedural rival. Given that structure, a result that shows the composite clinical-worsening endpoint favors the procedure arm over medical therapy alone, and that the effect holds through the three-year follow-up window, would be the finding that distinguishes this trial in a field where no other procedural therapy has established benefit in this population. NCT05824923A Trial to Evaluate the Safety and Efficacy of Pulmonary Artery Denervation for the Treatment of Pulmonary Hypertension Associated With Left Heart FailureNCT05824923
This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.