NCT05824923 A Trial to Evaluate the Safety and Efficacy of Pulmonary Artery Denervation for the Treatment of Pulmonary Hypertension Associated With Left Heart Failure
| NCT ID | NCT05824923 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Pulnovo Medical (Wuxi) Co., Ltd. |
| Condition | Pulmonary Hypertension |
| Study Type | INTERVENTIONAL |
| Enrollment | 264 participants |
| Start Date | 2023-08-14 |
| Primary Completion | 2025-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 264 participants in total. It began in 2023-08-14 with a primary completion date of 2025-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Yaling Han
PRINCIPAL INVESTIGATOR
The General Hospital of Northern Theater Command
Frequently Asked Questions
Who can join the NCT05824923 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Pulmonary Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05824923 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 264 participants.
Is NCT05824923 currently recruiting?
Yes, NCT05824923 is actively recruiting participants. Contact the research team at guwen@pulnovomed.com for enrollment information.
Where is the NCT05824923 trial being conducted?
This trial is being conducted at Shenyang, China.
Who is sponsoring the NCT05824923 clinical trial?
NCT05824923 is sponsored by Pulnovo Medical (Wuxi) Co., Ltd.. The principal investigator is Yaling Han at The General Hospital of Northern Theater Command. The trial plans to enroll 264 participants.