Pulmonary Arteyr Denervation for HF Without PH

NCT06323512 | Completed DMC

• 1 other identifier: Nanjing
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (2)

• Left ventricular dp/dt (maximal and minimal)

  before and immediately after PADN procedures

• Left ventricular end-systolic pressure (maximal and minimal)

  Before and immediately after PADN procedures

Secondary Outcomes (3)

• Pulmonary arterial wedge pressure

  Before, after-PADN and at 3 months

• Tricuspid annuls peak systolic excursion

  Before, after-PADN and at 3 months

• NT-proBNP

  Before, after-PADN and at 3 months

Interventions

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with heart failure

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hospital

Nanjing, Please Select, 210006, China

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Hongjuan C Peng, MBBS

  Nanjing First Hospital, Nanjing Medical University, China

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: March 21, 2024
• Study Start: August 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: May 1, 2025
• Last Updated: June 26, 2025

Record last verified: 2025-06

Locations

CN (1)