A Trial to Evaluate the Safety and Efficacy of Pulmonary Artery Denervation for the Treatment of Pulmonary Hypertension Associated With Left Heart Failure
NCT ID: NCT05824923
Last Updated: 2024-09-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
264 participants
INTERVENTIONAL
2023-08-14
2027-02-28
Brief Summary
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Detailed Description
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Approximately 264 participants will be enrolled at up to 39 centers in China and followed for 3 years. The safety and efficacy of the PADN system, including RF ablation catheter and generator will be evaluated by comparing the therapeutic effect of the PADN group and the control group.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Pulmonary Artery Denervation (PADN)
Patients in the PADN group will receive pulmonary artery denervation procedure.
Pulmonary arterial denervation
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 ℃ for 120 seconds each will be performed in ostium of the left PA and the distal bifurcation area of the main PA.
For non-atrial fibrillation patients, dual antiplatelet therapy for 1 month after PADN is recommended. Patients with atrial fibrillation should continue new oral anticoagulants and patients who underwent metal valve replacement should continued oral warfarin anticoagulation according to guidelines, which could determined by the physician.
Guideline-directed medical therapy (GDMT) for heart failure
GDMT medication recommendation including:
* Angiotensin-converting enzyme inhibitor (ACEI) or angiotensin-receptor blocker (ARB) or angiotensin receptor-neprilysin inhibitor (ARNI)
* Beta-receptor blocker (BB)
* Mineralocorticoid receptor antagonist (MRA)
* Sodium-glucose co-transporter 2 (SGLT2) inhibitor
* Diuretics
The medication regimen (type and dosage) will be the investigator's discretion in accordance with the 2023 ESC Guidelines for Heart Failure. The type and dosage of all GDMT medications (except for diuretics) should remain unchanged through follow-up duration (at 12-month visit), unless the participant's conditions need adjust of GDMT regimens. Dosage and single or combination of diuretics are all left at physician's discretion.
Guideline-directed medical therapy (GDMT) for heart failure
Patients in the control group will take their baseline anti-heart failure medications at the original doses according to 2023 ESC Guidelines for heart failure, without any changes except when medically required. The anti-heart failure drugs treatment is consistent in both arms.
Guideline-directed medical therapy (GDMT) for heart failure
GDMT medication recommendation including:
* Angiotensin-converting enzyme inhibitor (ACEI) or angiotensin-receptor blocker (ARB) or angiotensin receptor-neprilysin inhibitor (ARNI)
* Beta-receptor blocker (BB)
* Mineralocorticoid receptor antagonist (MRA)
* Sodium-glucose co-transporter 2 (SGLT2) inhibitor
* Diuretics
The medication regimen (type and dosage) will be the investigator's discretion in accordance with the 2023 ESC Guidelines for Heart Failure. The type and dosage of all GDMT medications (except for diuretics) should remain unchanged through follow-up duration (at 12-month visit), unless the participant's conditions need adjust of GDMT regimens. Dosage and single or combination of diuretics are all left at physician's discretion.
Interventions
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Pulmonary arterial denervation
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 ℃ for 120 seconds each will be performed in ostium of the left PA and the distal bifurcation area of the main PA.
For non-atrial fibrillation patients, dual antiplatelet therapy for 1 month after PADN is recommended. Patients with atrial fibrillation should continue new oral anticoagulants and patients who underwent metal valve replacement should continued oral warfarin anticoagulation according to guidelines, which could determined by the physician.
Guideline-directed medical therapy (GDMT) for heart failure
GDMT medication recommendation including:
* Angiotensin-converting enzyme inhibitor (ACEI) or angiotensin-receptor blocker (ARB) or angiotensin receptor-neprilysin inhibitor (ARNI)
* Beta-receptor blocker (BB)
* Mineralocorticoid receptor antagonist (MRA)
* Sodium-glucose co-transporter 2 (SGLT2) inhibitor
* Diuretics
The medication regimen (type and dosage) will be the investigator's discretion in accordance with the 2023 ESC Guidelines for Heart Failure. The type and dosage of all GDMT medications (except for diuretics) should remain unchanged through follow-up duration (at 12-month visit), unless the participant's conditions need adjust of GDMT regimens. Dosage and single or combination of diuretics are all left at physician's discretion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Diagnosed with chronic heart failure for at least 3 months, and have received the GDMT pharmacological treatment based on the 2023 ESC Guidelines for Heart Failure for at least 1 month;
3. Clinically stable defined by
1. No intravenous diuretics, inotropes or vasodilators for at least 1 month, and
2. Systolic blood pressure (SBP) ≥ 100 and \< 160 mmHg and resting heart rate (HR) ≥50 and \<100 bpm (\<110 bpm for atrial fibrillation) on the day of the procedure
4. New York Heart Association (NYHA) class II-IVa;
5. 6MWD ≥ 100 m and \< 450 m;
6. NT-proBNP \> 125 pg/mL (BNP \> 35 pg/mL);
7. Hemodynamic indicators (RHC) :
1. Mean pulmonary arterial pressure (mPAP) \> 20 mmHg
2. Pulmonary capillary wedge pressure (PCWP) \>15 mmHg
8. Understand and be willing to sign informed consent, and be willing to follow the follow-up plan required by the protocol.
Exclusion Criteria
1. Hypertrophic cardiomyopathy with left ventricular outflow tract obstruction or systolic anterior motion; pericardial disease; infiltrative or inflammatory myocardial disease; valvular stenosis of any of the 4 valves, or severe regurgitation of aortic and pulmonary valves, or active endocarditis; or
2. Symptomatic carotid stenosis, or transient ischemic attack (TIA) or stroke within 30 days prior to randomization; or
3. Untreated congenital heart disease; or
4. Have received any revascularization, including coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) within 6 months prior to randomization; or anticipated to undergo coronary revascularization (CABG or PCI) within 6 months; or
5. Artificial pacemakers, including single-chamber, dual-chamber and three-chamber pacemakers, have been implanted or are anticipated to be implanted within 6 months; or
6. Anticipated to undergo ablation of atrial fibrillation within 6 months; or
7. Anticipated to undergo heart valve surgery (valve replacement, valvuloplasty) within 6 months; or
8. Listing for heart/heart-lung transplantation or anticipated to implant a ventricular assist device (VAD)
2. Other types of pulmonary hypertension, including WHO Group1, Group3, Group4, Group5;
3. Received pulmonary arterial hypertension (PAH) targeted drugs within 1 month prior to randomization;
4. Anticipated to undergo any surgery within 6 months;
5. The cardiac index (CI) of RHC \< 1.5L/min/m²;
6. Severe renal insufficiency (eGFR \<30mL/min/1.73m² by MDRD formula);
7. Severe liver insufficiency (Child-Pugh classification C);
8. Platelet count \< 50 × 10\^9/L;
9. Life expectancy \<1 year;
10. Systemic inflammation or other disease requiring long-term use of glucocorticoids or immunosuppressants;
11. Active infection requiring oral or intravenous antibiotics;
12. Body mass index (BMI) \>40 kg/m²;
13. Pregnant or lactating women, or plan to pregnant in one year;
14. Participated in other clinical trials within 3 months prior to signing the informed consent;
15. Any other circumstances that investigators deem inappropriate to participate in this trial.
18 Years
75 Years
ALL
No
Sponsors
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The General Hospital of Northern Theater Command
OTHER
The First Affiliated Hospital with Nanjing Medical University
OTHER
First Hospital of Tsinghua University
OTHER
Cangzhou Central Hospital
OTHER
Chinese Academy of Medical Sciences, Fuwai Hospital
OTHER
Guangdong Provincial People's Hospital
OTHER
The First Affiliated Hospital of Guangzhou Medical University
OTHER
First Affiliated Hospital of Harbin Medical University
OTHER
Tongji Hospital
OTHER
Second Hospital of Jilin University
OTHER
China-Japan Union Hospital, Jilin University
OTHER
Shanxi Cardiovascular Hospital
OTHER
RenJi Hospital
OTHER
Shanghai 10th People's Hospital
OTHER
Beijing Anzhen Hospital
OTHER
West China Hospital
OTHER
Sichuan Academy of Medical Sciences
OTHER
The First Affiliated Hospital of Soochow University
OTHER
TEDA International Cardiovascular Hospital
OTHER
Tianjin Medical University General Hospital
OTHER
Renmin Hospital of Wuhan University
OTHER
Zhongnan Hospital
OTHER
First Affiliated Hospital Xi'an Jiaotong University
OTHER
Xiamen Cardiovascular Hospital, Xiamen University
OTHER
Zhejiang University
OTHER
Shengjing Hospital
OTHER
First Affiliated Hospital of Fujian Medical University
OTHER
First Affiliated Hospital of Wenzhou Medical University
OTHER
Gansu Provincial Hospital
OTHER
Yanan Hospital of Kunming City
UNKNOWN
First Affiliated Hospital of Chongqing Medical University
OTHER
Huaihe Hospital of Henan University
OTHER
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
The First Affiliated Hospital of Nanchang University
OTHER
Hunan Provincial People's Hospital
OTHER
Tianjin Medical University Second Hospital
OTHER
First Affiliated Hospital, Sun Yat-Sen University
OTHER
The First Hospital of Jilin University
OTHER
Pulnovo Medical (Wuxi) Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Yaling Han
Role: PRINCIPAL_INVESTIGATOR
The General Hospital of Northern Theater Command
Locations
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General Hospital of Northern Theater Command
Shenyang, Liaoning, China
Countries
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Central Contacts
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Other Identifiers
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Pulnovo-CO-2022-01
Identifier Type: -
Identifier Source: org_study_id
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