Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06323512
Status:
RECRUITING
Last Update Posted:
2024-04-24
First Post:
2024-03-14
Brief Title:
Pulmonary Arteyr Denervation for HF Without PH
Sponsor:
Nanjing First Hospital Nanjing Medical University
Organization:
Nanjing First Hospital Nanjing Medical University
Study Overview
Official Title:
Pulmonary Artery Denervation for Treatment of Patients With Heart Failure Without Pulmonary Hypertension a Safety and Proof-of-principle Cohort Study
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 N30 15 with HFrEF and another 15 with HFpEF
Detailed 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 CardiologyAmerican Heart Association ACCAHA 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 ACCAHA 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 cavaright jugular vein access or exhibited a plasma N-terminal prohormone B-type natriuretic peptide NT-proBNP level below 300 pgml 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
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 cavaright jugular vein access or exhibited a plasma N-terminal prohormone B-type natriuretic peptide NT-proBNP level below 300 pgml 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None