Health TrialsbyHealthPanel

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

ConditionsPulmonary HypertensionHeart Failure With Reduced Ejection FractionHypertensionVascular DiseasesCardiovascular DiseasesHeart FailureHeart Failure With Preserved Ejection FractionHeart 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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Pulmonary arterial denervation

    Procedure/Surgery

    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.

  • Guideline-directed medical therapy (GDMT) for heart failure

    Drug

    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.

Treatment groups

264 Participants
are divided into 2 treatment groups
Group A: Pulmonary Artery Denervation (PADN)Experimental treatment 2 interventions
Group B: Guideline-directed medical therapy (GDMT) for heart failureActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Clinical Worsening, defined as the occurrence of any of the followings:

1. Requiring intravenous medication (inotropes, diuretics or vasodilators) due to worsening of heart failure 2. Rehospitalization due to heart failure 3. 6MWD decreased by \> 10% or \> 30m compared with baseline 4. Referral for heart/heart-lung transplantation 5. All-cause death

Time frame
immediately after the randomization to the last enrolled subject having at least 6 months follow-up

Secondary outcomes

1

Parameters measured by transthoracic echocardiography(TTE)

Changes in left ventricular Tei index from baseline.

Time frame
6 months, 1 year, 3 years
2

Parameters measured by transthoracic echocardiography(TTE)

Changes in left ventricular ejection fraction (LVEF) from baseline.

Time frame
6 months, 1 year, 3 years
3

Parameters measured by transthoracic echocardiography(TTE)

Changes in left ventricular end-diastolic diameter (LVDd) from baseline.

Time frame
6 months, 1 year, 3 years
4

Parameters measured by transthoracic echocardiography(TTE)

Changes in left ventricular end-systolic diameter (LVSd) from baseline.

Time frame
6 months, 1 year, 3 years

Other outcomes

1

Safety Outcome: AESI

Adverse events of special interest (AESI), defined as complications occurring within 30 days after the procedure, include: 1. Thrombosis and embolism 2. Perforation or dissection of the pulmonary artery requiring surgical treatment 3. Pulmonary aneurysm 4. Pulmonary artery stenosis 5. Hemoptysis requiring surgical treatment 6. Recurrent laryngeal nerve injury 7. Complications at puncture site (including pain, infection, bleeding, hematoma, etc.) 8. All-cause death 9. Endotracheal intubation 10. Mechanical circulation support 11. Permanent implantation of a pacemaker or defibrillator

Time frame
within 30 days after the procedure
2

Safety Outcome: AE and SAE

Adverse events (AE) and serious adverse events (SAE)

Time frame
throughout the clincialtrial

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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
Apply now