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

• Status: Not yet recruiting
• Trial end date: 2027-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pulnovo Medical (Wuxi) Co., Ltd.
• Collaborators: Beijing Anzhen Hospital; Cangzhou Central Hospital; China-Japan Union Hospital, Jilin University; First Affiliated Hospital of Fujian Medical University; First Affiliated Hospital of Harbin Medical University; First Affiliated Hospital of Wenzhou Medical University; First Affiliated Hospital Xi'an Jiaotong University; First Hospital of Tsinghua University; Fuwai Yunnan Cardiovascular Hospital; Guangdong Provincial People's Hospital; RenJi Hospital; Renmin Hospital of Wuhan University; Second Hospital of Jilin University; Shanghai 10th People's Hospital; Shanxi Cardiovascular Hospital; Shengjing Hospital; Sichuan Academy of Medical Sciences; TEDA International Cardiovascular Hospital; The First Affiliated Hospital of Guangzhou Medical University; The First Affiliated Hospital of Soochow University; The First Affiliated Hospital with Nanjing Medical University; The General Hospital of Northern Theater Command; Tianjin Medical University General Hospital; Tongji Hospital; West China Hospital; Wuhan University; Xiamen Cardiovascular Hospital, Xiamen University; Zhejiang University

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 2022 AHA/ACC 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. ACC/AHA stage of heart failure B-C;

5. New York Heart Association (NYHA) class II-IVa;

6. World Health Organization (WHO) functional class II-IV;

7. 6MWD ≥ 100 m and < 450 m;

8. NT-proBNP > 600 pg/mL (BNP > 150 pg/mL), or NT-proBNP > 400 pg/mL (BNP >100pg/mL) and has been hospitalized for heart failure in the past 1 year;

9. Hemodynamic indicators (RHC) :

1. Mean pulmonary arterial pressure (mPAP) > 25mmHg

2. Pulmonary capillary wedge pressure (PCWP) >15mmHg

10. 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 (LV) outflow tract obstruction or systolic anterior motion (SAM); pericardial disease; infiltrative or inflammatory myocardial disease; valvular heart disease with moderate or severe stenosis of any of the 4 valves, or severe regurgitation of any of the 4 valves, or active endocarditis; or

2. Symptomatic carotid stenosis, or transient ischemic attack (TIA) or stroke within 30 days prior to randomization; or

3. Complex 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 B-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. Cannot tolerate any GDMT medicine;

13. Body mass index (BMI) >40 kg/m²;

14. Pregnant or lactating women, or plan to pregnant in one year;

15. Participated in other clinical trials within 3 months prior to signing the informed consent;

16. Any other circumstances that investigators deem inappropriate to participate in this trial.