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Completed

NCT Number: NCT06323512

Pulmonary Arteyr Denervation for HF Without PH

Prolonged pulmonary venous congestion culminates in pulmonary hypertension, defined as a mean pulmonary arterial pressure > 20 mmHg and pulmonary artery wedge pressure >15 mmHg at rest, as determined by right heart catheterization. Pulmonary hypertension secondary to heart failure (PH-HF) is further stratified into isolated post-capillary pulmonary hypertension (Ipc-PH, pulmonary vascular resistance (PVR) is ≤2 Woods Unit) and combined pre- and post-capillary pulmonary hypertension (Cpc-PH, PVR > 2 Woods Unit), the later reflecting additional pulmonary vascular constriction or remodeling in addition to passive PH. While medications tailored for World Health Organization defined Group I pulmonary arterial hypertension are not endorsed for PH-HF according to current guidelines, the coexistence of pulmonary hypertension exacerbates the severity of heart failure. Given the presence of pulmonary arterial vasoconstrictor and heightened sympathetic nervous activity in patients with heart failure, the PADN-5 study has demonstrated the safety and efficacy of pulmonary artery denervation (PADN) for patients with CpcPH, characterized by the improvements in left ventricular ejection fraction, cardiac output, clinical outcome, and reductions in left atrial pressure, pulmonary arterial pressure, and PVR. Our objective is to assess the feasibility, safety, and efficacy of PADN for patients with heart failure independent of left ventricular ejection fraction (HFrEF or HFpEF) without pulmonary hypertension (N=30, 15 with HFrEF and another 15 with HFpEF).

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nanjing First Hospital

Nanjing, Please Select, 210006, China

About this study

We conducted a safety and proof-of-principle cohort study at a single centre in China. Eligible patients, aged 18 years or greater, had a documented history of chronic (≥6 months) ischaemic or non-ischaemic cardiomyopathy. They also met the American College of Cardiology/American Heart Association (ACC/AHA) stage C heart failure criteria, with New York Heart Association (NYHA) class III or ambulatory class IV symptoms. Additionally, participants were required to have been receiving guideline-directed medical therapy for at least three months, as tolerated per ACC/AHA guidelines.

Further inclusion criteria encompassed a pulmonary artery wedge pressure exceeding 15 mm Hg, a mean pulmonary arterial pressure less than or equal to 20 mm Hg, and pulmonary vascular resistance (PVR) less than or equal to 2 Woods Unit. Patients were ineligible if they lacked patent femoral venous or inferior vena cava/right jugular vein access, or exhibited a plasma N-terminal prohormone B-type natriuretic peptide (NT-proBNP) level below 300 pg/ml, had experienced a stroke or thromboembolic event within the preceding 12 months, had patent foramen ovale or atrial septal defect, or presented with severe (grade 4) mitral regurgitation. Patients with coagulation disorders or contraindications for oral anticoagulation, as well as those harboring pulmonary artery, right atrial, or right ventricular thrombus, were also excluded.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • aged 18 years or greater, had a documented history of chronic (≥6 months) ischaemic or non-ischaemic cardiomyopathy; ACC/AHA stage C heart failure criteria, NYHA class III or ambulatory class IV symptoms; on GDMT for heart failure at least three months; PAWP exceeding 15 mm Hg, mean PAP less than or equal to 20 mm Hg, and PVR less than or equal to 2 Woods Unit

Exclusion criteria

Patients lacked patent femoral venous or inferior vena cava/right jugular vein access; had experienced a stroke or thromboembolic event within the preceding 12 months, had patent foramen ovale or atrial septal defect, or presented with severe (grade 4) mitral regurgitation; had coagulation disorders or contraindications for oral anticoagulation; had harboring pulmonary artery, right atrial or right ventricular thrombus; had undergone pacemaker implantation within 1 month.

Treatment and study plan

Pulmonary artery denervation (PADN)

Device

Combining invasive angiography with pulmonary artery CTA is frequently employed to determine the final size of the PADN catheter, aiming for an expected ratio of distal ring/vessel diameter between 1.1 and 1.2. The PADN system comprises a radiofrequency generator, connecting tubing and control handle, and the PADN catheter. The main interface of the radiofrequency generator offers multiple language options and displays parameters such as temperature, impedance, energy, and ablation time. The generator features three control modes: temperature control, power control, and a combination of both.

Primary outcomes

  1. Left ventricular dp/dt (maximal and minimal)

    Time frame: before and immediately after PADN procedures

  2. Left ventricular end-systolic pressure (maximal and minimal)

    Time frame: Before and immediately after PADN procedures

Secondary outcomes

  1. Pulmonary arterial wedge pressure

    Time frame: Before, after-PADN and at 3 months

    PAWP

  2. Tricuspid annuls peak systolic excursion

    Time frame: Before, after-PADN and at 3 months

    TAPSE

  3. NT-proBNP

    Time frame: Before, after-PADN and at 3 months

    N-terminal-pro brain natriuretic peptide

Sponsors and collaborators

Lead sponsor

Nanjing First Hospital, Nanjing Medical University

Other

Registry information

Official study title

Pulmonary Artery Denervation for Treatment of Patients With Heart Failure Without Pulmonary Hypertension: a Safety and Proof-of-principle Cohort Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 21, 2024
Registry last updated
Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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