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The goal of this pilot study is to evaluate the safety and efficacy of pulmonary artery denervation (PADN) in Combined Post- and Pre- Capillary Pulmonary Hypertension Associated with Chronic Heart Failure.
Participants who have received guideline-directed medical therapy (GDMT) according to 2022 AHA/ACC Guidelines for Heart Failure (HF) and have been clinically stable for at least 1 month, will be treated with PADN and followed for 1 year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulmonary Artery Denervation (PADN) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulmonary Artery Denervation | Procedure | Contrast pulmonary artery (PA) angiography will be performed to localize the pulmonary artery bifurcation level and calculate the PA diameter. Once the anatomy deemed acceptable, the radiofrequency ablation catheter will be introduced into ostium of the left PA and the distal bifurcation area of the main PA. The catheter will be manoeuvred within the PA to allow energy delivery in a circumferential manner to ensure that the electrodes are tightly in contact with the endovascular surface. About three ablations at 45-55°C for 120 seconds each will be performed in ostium of the left PA and the distal bifurcation area of the main PA. |
| Measure | Description | Time Frame |
|---|---|---|
| 6-minute walk distance (6MWD) difference | The primary endpoint is change in 6-min-walk distance (6-MWD) from baseline to 6months. | 6 months |
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Inclusion Criteria:
Age ≥18, ≤85 years;
PH must be confirmed by RHC, defined as:
Chronic heart failure has been diagnosed at least 3 months before screening and have been treated on the GDMT according to 2022 AHA/ACC Guidelines for Heart Failure for at least 1 month;
Clinically stable HF for at least 1 month, defined as:
NYHA class II-IVa;
6MWD ≥ 100 m and ≤ 450 m;
NT-proBNP >125pg/mL (or BNP > 35pg/mL);
Understand and be willing to sign informed consent and be strictly willing to follow the protocol.
Exclusion Criteria:
Any of the following:
Received pulmonary arterial hypertension (PAH) targeted drugs within 1 month prior to randomization;
Anticipated to undergo any surgery within the next 6 months;
Cardiac index (CI) measured by RHC < 1.5L/min/m2;
Severe renal insufficiency (eGFR < 30mL/min/1.73m2 by MDRD formula);
Severe liver insufficiency (Child-Pugh classification B-C);
Platelet count < 50 × 109/L;
Life expectancy < 1 year;
Systemic inflammation or other disease requiring long-term use of glucocorticoids or immunosuppressants;
Active infection requiring oral or intravenous antibiotics;
Cannot tolerate warfarin, aspirin, clopidogrel, and any of GDMT medicines;
Body mass index (BMI) > 40 kg/m²;
Pregnant or lactating women, or planning to be pregnant within one year;
Participation in other clinical trials within 3 months prior to signing the informed consent;
Any other circumstances that investigators deemed inappropriate to participate in this trial.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Santa Marta | Lisbon | Portugal |
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|
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
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