NCT06323512Completed
Pulmonary Arteyr Denervation for HF Without PH
Pulmonary Artery Denervation for Treatment of Patients With Heart Failure Without Pulmonary Hypertension: a Safety and Proof-of-principle Cohort Study
Source: ClinicalTrials.gov · Last updated 26 Jun 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 20 (actual)
- First submitted
- 14 Mar 2024
- Start date
- 1 Aug 2024
- Primary completion date
- 1 Feb 2025
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical University
- NCT number
- NCT06323512
What you commit to
- Study type: Observational
- Participants enrolled: 20
- From 1 Aug 2024 to the primary completion date, 1 Feb 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nanjing First Hospital Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.