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this study aims to investigate the efficacy and safety of PADN therapy compared with standard medical therapy in patients diagnosed with pulmonary hypertension after M-TEER, thereby providing evidence for clinical treatment decision-making
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PADN group (receiving PADN plus standard medical therapy) | Experimental | PADN group (receiving PADN plus standard medical therapy) |
|
| Control group (receiving standard medical therapy alone) | Placebo Comparator | Control group (receiving standard medical therapy alone) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous Pulmonary Artery Denervation (PADN) | Device | **PADN Procedure Steps:**
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical worsening event | defined as the occurrence of any of the following:
| From enrollment up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in pulmonary vascular resistance (right heart catheterization) | Changes from baseline in pulmonary vascular resistance (PVR); Unit of measure: Wood units | From enrollment up to 12 months |
| Changes from baseline in echocardiographic linear dimension parameters |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiang CHEN, Dr | Contact | +8618033997788 | seanchenx@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Structural Heart Disease Unit, Xiamen Cardiovacular Hospital | Recruiting | Xiamen | Fujian | 361000 | China |
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|
| Control group (receiving standard medical therapy alone) | Drug | Control group (receiving standard medical therapy alone) |
|
Changes from baseline in right atrial diameter (RAD), left atrial diameter (LAD), left ventricular internal diameter at end-diastole (LVIDd), left ventricular posterior wall thickness at end-systole (LVPWd), and tricuspid annular plane systolic excursion (TAPSE); Unit of measure: millimeters (mm) |
| From enrollment up to 12 months |
| Changes from baseline in echocardiographic percentage functional indices |
| From enrollment up to 12 months |
| Changes from baseline in cardiac output (right heart catheterization) |
| From enrollment up to 12 months |
| Changes from baseline in WHO functional class | From enrollment up to 12 months |
| Changes from baseline in NT-proBNP/BNP | From enrollment up to 12 months |
| Changes from baseline in 6-minute walk distance (6MWD) | From enrollment up to 12 months |
| Changes from baseline in Short Form-36 (SF-36) Health Survey scale score | The SF-36 scale ranges from 0 to 100, where higher scores indicate a better outcome (Minimum = 0, Maximum = 100). | From enrollment up to 12 months |
| All-cause rehospitalization rate | From enrollment up to 12 months |
| Incidence of worsening heart failure symptoms requiring intravenous therapy | From enrollment up to 12 months |
| Heart failure-related rehospitalization rate | From enrollment up to 12 months |
| Rate of need for heart/lung transplantation | From enrollment up to 12 months |
| Changes from baseline in intracardiac pressure parameters (right heart catheterization) |
| From enrollment up to 12 months |
| Changes from baseline in cardiac index (right heart catheterization) |
| From enrollment up to 12 months |
| Changes from baseline in pulmonary arterial compliance (right heart catheterization) |
| From enrollment up to 12 months |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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