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

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.

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

Interventions

PROCEDURE

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.

DRUG

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.

Sponsors & Collaborators

• The General Hospital of Northern Theater Command

  collaborator OTHER

• The First Affiliated Hospital with Nanjing Medical University

  collaborator OTHER

• First Hospital of Tsinghua University

  collaborator OTHER

• Cangzhou Central Hospital

  collaborator OTHER

• Chinese Academy of Medical Sciences, Fuwai Hospital

  collaborator OTHER

• Guangdong Provincial People's Hospital

  collaborator OTHER

• The First Affiliated Hospital of Guangzhou Medical University

  collaborator OTHER

• First Affiliated Hospital of Harbin Medical University

  collaborator OTHER

• Tongji Hospital

  collaborator OTHER

• Second Hospital of Jilin University

  collaborator OTHER

• China-Japan Union Hospital, Jilin University

  collaborator OTHER

• Shanxi Cardiovascular Hospital

  collaborator OTHER

• RenJi Hospital

  collaborator OTHER

• Shanghai 10th People's Hospital

  collaborator OTHER

• Beijing Anzhen Hospital

  collaborator OTHER

• West China Hospital

  collaborator OTHER

• Sichuan Academy of Medical Sciences

  collaborator OTHER

• The First Affiliated Hospital of Soochow University

  collaborator OTHER

• TEDA International Cardiovascular Hospital

  collaborator OTHER

• Tianjin Medical University General Hospital

  collaborator OTHER

• Renmin Hospital of Wuhan University

  collaborator OTHER

• Zhongnan Hospital

  collaborator OTHER

• First Affiliated Hospital Xi'an Jiaotong University

  collaborator OTHER

• Xiamen Cardiovascular Hospital, Xiamen University

  collaborator OTHER

• Zhejiang University

  collaborator OTHER

• Shengjing Hospital

  collaborator OTHER

• First Affiliated Hospital of Fujian Medical University

  collaborator OTHER

• First Affiliated Hospital of Wenzhou Medical University

  collaborator OTHER

• Gansu Provincial Hospital

  collaborator OTHER

• Yanan Hospital of Kunming City

  collaborator UNKNOWN

• First Affiliated Hospital of Chongqing Medical University

  collaborator OTHER

• Huaihe Hospital of Henan University

  collaborator OTHER

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  collaborator OTHER

• The First Affiliated Hospital of Nanchang University

  collaborator OTHER

• Hunan Provincial People's Hospital

  collaborator OTHER

• Tianjin Medical University Second Hospital

  collaborator OTHER

• First Affiliated Hospital, Sun Yat-Sen University

  collaborator OTHER

• The First Hospital of Jilin University

  collaborator OTHER

• Pulnovo Medical (Wuxi) Co., Ltd.

  lead INDUSTRY

Principal Investigators

• Yaling Han · The General Hospital of Northern Theater Command

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-08-14

Primary Completion

2025-08-31

Completion

2027-02-28

Countries

• China

Study Locations