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

ConditionsPulmonary 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

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18-75

SponsorPulnovo Medical (Wuxi) Co., Ltd.

About this trial

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

Qualifiers

Age ≥18, ≤75 years old;

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;

Clinically stable defined by

No intravenous diuretics, inotropes or vasodilators for at least 1 month, and

Disqualifiers

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

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

Untreated congenital heart disease; or

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

Trial design

Treatments tested in this trial

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

Treatment groups

264 Participants

are divided into 2 treatment groups

Sponsors and collaborators

Pulnovo Medical (Wuxi) Co., Ltd.

Lead sponsor

The General Hospital of Northern Theater Command

Collaborator

The First Affiliated Hospital with Nanjing Medical University

Collaborator

First Hospital of Tsinghua University

Collaborator

Cangzhou Central Hospital

Collaborator

Chinese Academy of Medical Sciences, Fuwai Hospital

Collaborator

Guangdong Provincial People's Hospital

Collaborator

The First Affiliated Hospital of Guangzhou Medical University

Collaborator

First Affiliated Hospital of Harbin Medical University

Collaborator

Tongji Hospital

Collaborator

Second Hospital of Jilin University

Collaborator

China-Japan Union Hospital, Jilin University

Collaborator

Shanxi Cardiovascular Hospital

Collaborator

RenJi Hospital

Collaborator

Shanghai 10th People's Hospital

Collaborator

Beijing Anzhen Hospital

Collaborator

West China Hospital

Collaborator

Sichuan Academy of Medical Sciences

Collaborator

The First Affiliated Hospital of Soochow University

Collaborator

TEDA International Cardiovascular Hospital

Collaborator

Tianjin Medical University General Hospital

Collaborator

Renmin Hospital of Wuhan University

Collaborator

Zhongnan Hospital

Collaborator

First Affiliated Hospital Xi'an Jiaotong University

Collaborator

Xiamen Cardiovascular Hospital, Xiamen University

Collaborator

Zhejiang University

Collaborator

Shengjing Hospital

Collaborator

First Affiliated Hospital of Fujian Medical University

Collaborator

First Affiliated Hospital of Wenzhou Medical University

Collaborator

Gansu Provincial Hospital

Collaborator

Yan'an Affiliated Hospital of Kunming Medical University

Collaborator

First Affiliated Hospital of Chongqing Medical University

Collaborator

Huaihe Hospital of Henan University

Collaborator

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

Collaborator

The First Affiliated Hospital of Nanchang University

Collaborator

Hunan Provincial People's Hospital

Collaborator

Tianjin Medical University Second Hospital

Collaborator

First Affiliated Hospital, Sun Yat-Sen University

Collaborator

The First Hospital of Jilin University

Collaborator

Source ClinicalTrials.gov