A Trial to Evaluate the Safety and Efficacy of Pulmonary Artery Denervation for the Treatment of Pulmonary Hypertension Associated With Left Heart Failure
Condition(s) studied
Investigational drug(s) / intervention(s)
Pulmonary arterial denervation: Contrast pulmonary artery (PA) angiography will be performed to localize the pulmonary artery bifurcation level and calculate the PA diameter. Once the anatomy deemed acceptable, the radiofrequency ablation catheter will be introduced into ostium of the left PA and the distal bifurcation area of the main PA. The catheter will be manoeuvred within the PA to allow energy delivery in a circumferential manner to ensure that the electrodes are tightly in contact with the endovascular surface. About three ablations at 45-55 ℃ for 120 seconds each will be performed in ostium of the left PA and the distal bifurcation area of the main PA. For non-atrial fibrillation patients, dual antiplatelet therapy for 1 month after PADN is recommended. Patients with atrial fibrillation should continue new oral anticoagulants and patients who underwent metal valve replacement should continued oral warfarin anticoagulation according to guidelines, which could determined by the physician.
Guideline-directed medical therapy (GDMT) for heart failure: GDMT medication recommendation including: * Angiotensin-converting enzyme inhibitor (ACEI) or angiotensin-receptor blocker (ARB) or angiotensin receptor-neprilysin inhibitor (ARNI) * Beta-receptor blocker (BB) * Mineralocorticoid receptor antagonist (MRA) * Sodium-glucose co-transporter 2 (SGLT2) inhibitor * Diuretics The medication regimen (type and dosage) will be the investigator's discretion in accordance with the 2023 ESC Guidelines for Heart Failure. The type and dosage of all GDMT medications (except for diuretics) should remain unchanged through follow-up duration (at 12-month visit), unless the participant's conditions need adjust of GDMT regimens. Dosage and single or combination of diuretics are all left at physician's discretion.
Study summary
It's a phase III, prospective, multicenter, randomized controlled trial to evaluate the safety and efficacy of the pulmonary artery denervation (PADN) for heart failure (HF) patients diagnosed with pulmonary hypertension associate with left heart disease (PH-LHD) by right heart catheterization.
Eligibility
Primary outcome measure(s)
- Clinical Worsening, defined as the occurrence of any of the followings: — immediately after the randomization to the last enrolled subject having at least 6 months follow-up
1. Requiring intravenous medication (inotropes, diuretics or vasodilators) due to worsening of heart failure 2. Rehospitalization due to heart failure 3. 6MWD decreased by \> 10% or \> 30m compared with baseline 4. Referral for heart/heart-lung transplantation 5. All-cause death
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| General Hospital of Northern Theater Command | Shenyang | Liaoning |
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05824923 on ClinicalTrials.gov ↗ ← All trials in China