It's a phase III, prospective, multicenter, randomized controlled trial to evaluate the safety and efficacy of the pulmonary artery denervation (PADN) for heart failure (HF) patients diagnosed with pulmonary hypertension associate with left heart disease (PH-LHD) by right heart catheterization.
Chronic heart failure (CHF) patients who have received guideline-directed medical therapy (GDMT) based on the 2023 ESC Guidelines for HF and have reached clinical stable, and diagnosed with PH-LHD by right heart catheterization, will be randomized to the PADN group or control group in a 1:1 ratio to receive PADN combined with HF GDMT or HF GDMT, respectively. After the 12-month follow-up visit is completed, participants in the control group who still meet the inclusion and exclusion criteria can also choose to receive PADN. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
264
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.
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.
General Hospital of Northern Theater Command
Shenyang, Liaoning, China
RECRUITINGClinical Worsening, defined as the occurrence of any of the followings:
1. Requiring intravenous medication (inotropes, diuretics or vasodilators) due to worsening of heart failure 2. Rehospitalization due to heart failure 3. 6MWD decreased by \> 10% or \> 30m compared with baseline 4. Referral for heart/heart-lung transplantation 5. All-cause death
Time frame: immediately after the randomization to the last enrolled subject having at least 6 months follow-up
Parameters measured by transthoracic echocardiography(TTE)
Changes in left ventricular Tei index from baseline.
Time frame: 6 months, 1 year, 3 years
Parameters measured by transthoracic echocardiography(TTE)
Changes in left ventricular ejection fraction (LVEF) from baseline.
Time frame: 6 months, 1 year, 3 years
Parameters measured by transthoracic echocardiography(TTE)
Changes in left ventricular end-diastolic diameter (LVDd) from baseline.
Time frame: 6 months, 1 year, 3 years
Parameters measured by transthoracic echocardiography(TTE)
Changes in left ventricular end-systolic diameter (LVSd) from baseline.
Time frame: 6 months, 1 year, 3 years
Parameters measured by transthoracic echocardiography(TTE)
Changes in E/E' ratio from baseline.
Time frame: 6 months, 1 year, 3 years
Parameters measured by transthoracic echocardiography(TTE)
Changes in septum E' from baseline.
Time frame: 6 months, 1 year, 3 years
Parameters measured by transthoracic echocardiography(TTE)
Changes in lateral wall E' from baseline.
Time frame: 6 months, 1 year, 3 years
Parameters measured by transthoracic echocardiography(TTE)
Changes in left ventricular global longitudinal strain (LVGLS) from baseline.
Time frame: 6 months, 1 year, 3 years
N-terminal pro-B-type natriuretic peptide (NT-proBNP)
Changes in N-terminal pro-B-type natriuretic peptide (NT-proBNP) from baseline
Time frame: 6 months
6 minute walk distance(6MWD) difference from baseline
The 6MWD test was conducted according to the American Thoracic Society guidelines.
Time frame: 6 months, 1 year, 3 years
Changes in the Kansas City Cardiomyopathy Questionnaire(KCCQ) overall summary score from baseline
The KCCQ is a self-administered, 23-item questionnaire to provide a better description of quality of life in patients with heart failure. The overall summary score range from 0 to 100, higher score means higher quality of life.
Time frame: 1 month, 6 months, 1 year, 2 years, 3 years
Intravenous medication due to worsening of heart failure
Number of patients requiring intravenous medication (inotropes, diuretics or vasodilators) due to worsening of heart failure
Time frame: 1 month, 6 months, 1 year, 2 years, 3 years
Rehospitalization due to heart failure
Number of patients with rehospitalization due to heart failure
Time frame: 1 month, 6 months, 1 year, 2 years, 3 years
Heart/heart-lung transplantation
Number of patients referred for heart/heart-lung transplantation
Time frame: 1 month, 6 months, 1 year, 2 years, 3 years
All-cause death
Number of death due to any cause
Time frame: 1 month, 6 months, 1 year, 2 years, 3 years
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