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Active, not recruiting Phase 3

A Trial to Evaluate the Safety and Efficacy of Pulmonary Artery Denervation for the Treatment of Pulmonary Hypertension Associated With Left Heart Failure

NCT05824923 · tracked via the Priya Life Science China tracker
Sponsor
Pulnovo Medical (Wuxi) Co., Ltd
Phase
Phase 3
Started
2023-08-14
Last updated
2026-07-21

Condition(s) studied

Pulmonary HypertensionHeart Failure With Reduced Ejection FractionHypertensionVascular DiseasesCardiovascular DiseasesHeart FailureHeart Failure With Preserved Ejection FractionHeart Failure With Mid Range Ejection Fraction

Investigational drug(s) / intervention(s)

Pulmonary arterial denervationGuideline-directed medical therapy (GDMT) for heart failure

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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Age ≥18, ≤75 years old; 2. Diagnosed with chronic heart failure for at least 3 months, and have received the GDMT pharmacological treatment based on the 2023 ESC Guidelines for Heart Failure for at least 1 month; 3. Clinically stable defined by 1. No intravenous diuretics, inotropes or vasodilators for at least 1 month, and 2. Systolic blood pressure (SBP) ≥ 100 and \< 160 mmHg and resting heart rate (HR) ≥50 and \<100 bpm (\<110 bpm for atrial fibrillation) on the day of the procedure 4. New York Heart Association (NYHA) class II-IVa; 5. 6MWD ≥ 100 m and \< 450 m; 6. NT-proBNP \> 125 pg/mL (BNP \> 35 pg/mL); 7. Hemodynamic indicators (RHC) : 1. Mean pulmonary arterial pressure (mPAP) \> 20 mmHg 2. Pulmonary capillary wedge pressure (PCWP) \>15 mmHg 8. Understand and be willing to sign informed consent, and be willing to follow the follow-up plan required by the protocol. Exclusion Criteria: 1. Any of the following: 1. Hypertrophic cardiomyopathy with left ventricular outflow tract obstruction or systolic anterior motion; pericardial disease; infiltrative or inflammatory myocardial disease; valvular stenosis of any of the 4 valves, or severe regurgitation of aortic and pulmonary valves, or active endocarditis; or 2. Symptomatic carotid stenosis, or transient ischemic attack (TIA) or stroke within 30 days prior to randomization; or 3. Untreated congenital heart disease; or 4. Have received any revascularization, including coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) within 6 months prior to randomization; or anticipated to undergo coronary revascularization (CABG or PCI) within 6 months; or 5. Artificial pacemakers, including single-chamber, dual-chamber and three-chamber pacemakers, have been implanted or are anticipated to be implanted within 6 months; or 6. Anticipated to undergo ablation of atrial fibrillation within 6 months; or 7. Anticipated to undergo heart valve surgery (valve replacement, valvuloplasty) within 6 months; or 8. Listing for heart/heart-lung transplantation or anticipated to implant a ventricular assist device (VAD) 2. Other types of pulmonary hypertension, including WHO Group1, Group3, Group4, Group5; 3. Received pulmonary arterial hypertension (PAH) targeted drugs within 1 month prior to randomization; 4. Anticipated to undergo any surgery within 6 months; 5. The cardiac index (CI) of RHC \< 1.5L/min/m²; 6. Severe renal insufficiency (eGFR \<30mL/min/1.73m² by MDRD formula); 7. Severe liver insufficiency (Child-Pugh classification C); 8. Platelet count \< 50 × 10\^9/L; 9. Life expectancy \<1 year; 10. Systemic inflammation or other disease requiring long-term use of glucocorticoids or immunosuppressants; 11. Active infection requiring oral or intravenous antibiotics; 12. Body mass index (BMI) \>40 kg/m²; 13. Pregnant or lactating women, or plan to pregnant in one year; 14. Participated in other clinical trials within 3 months prior to signing the informed consent; 15. Any other circumstances that investigators deem inappropriate to participate in this trial.

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)

FacilityCityRegionStatus
General Hospital of Northern Theater Command Shenyang Liaoning

More Pulnovo Medical (Wuxi) Co., Ltd. trials in China

Official registry record

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