Evaluating Pulmonary Artery Denervation for Heart Failure with Pulmonary Hypertension

A Prospective, Multicenter, Randomized Controlled Trial to Evaluate the Safety and Efficacy of Single-use Ring-shaped Pulmonary Artery Radiofrequency (RF) Ablation Catheter and Pulmonary Artery RF Ablation Generator for the Treatment of Pulmonary Hypertension Associated With Left Heart Failure

This study is testing if a new procedure called pulmonary artery denervation can help people with heart failure and high blood pressure in their lungs feel better when added to their current treatment.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 264 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Pulnovo Medical (Wuxi) Co., Ltd. (industry)
• Locations: 1 site (Shenyang, Liaoning)
• Trial ID: NCT05824923 on ClinicalTrials.gov

What this trial studies

This phase III, multicenter, randomized controlled trial aims to assess the safety and efficacy of pulmonary artery denervation (PADN) in patients with chronic heart failure associated with pulmonary hypertension due to left heart disease. Participants aged 18 to 75, who are clinically stable and have been on guideline-directed medical therapy, will be randomly assigned to receive either PADN combined with their current treatment or continue with their treatment alone. The study will enroll approximately 264 participants across 39 centers in China and will follow them for three years to evaluate the therapeutic effects of the intervention compared to the control group.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with chronic heart failure and pulmonary hypertension who are clinically stable and have been on guideline-directed medical therapy.

Not a fit: Patients with conditions such as hypertrophic cardiomyopathy or those not meeting the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve outcomes for patients suffering from pulmonary hypertension associated with heart failure.

How similar studies have performed: While this approach is novel, similar studies have shown promise in treating related conditions, indicating potential for success.

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.

Where this trial is running

Shenyang, Liaoning

• General Hospital of Northern Theater Command — Shenyang, Liaoning, China (RECRUITING)

Study contacts

• Principal investigator: Yaling Han — The General Hospital of Northern Theater Command
• Study coordinator: Mark Gu

Conditions: Pulmonary Hypertension, Heart Failure With Reduced Ejection Fraction, Hypertension, Vascular Diseases, Cardiovascular Diseases, Heart Failure, Heart Failure With Preserved Ejection Fraction, Heart Failure With Mid Range Ejection Fraction