Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06323512 |
| Other study ID # |
Nanjing |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2024 |
| Est. completion date |
December 30, 2025 |
Study information
| Verified date |
April 2024 |
| Source |
Nanjing First Hospital, Nanjing Medical University |
| Contact |
Shao-Liang Chen |
| Phone |
13605157029 |
| Email |
chmengx[@]126.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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).
Description:
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 a 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.
