Pulmonary Artery Denervation for Heart Failure with Pulmonary Hypertension
A Trial to Evaluate the Safety and Efficacy of Pulmonary Artery Denervation for the Treatment of Pulmonary Hypertension Associated With Left Heart Failure
Recruiting
Phase 3Interventional Study
Pulmonary HypertensionHeart Failure With Reduced Ejection FractionHypertensionVascular DiseasesCardiovascular DiseasesHeart FailureHeart Failure With Preserved Ejection FractionHeart Failure With Mid Range Ejection Fraction
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
264 (estimated)
Sponsor
Pulnovo Medical (Wuxi) Co., Ltd. · Industry
Who this trial is looking for
This trial is looking for adults with chronic heart failure who also have pulmonary hypertension related to left heart disease. Participants will undergo a procedure called pulmonary artery denervation and will be monitored for safety and effectiveness.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 75 years old.
I have been diagnosed with chronic heart failure for at least 3 months.
I have been treated with recommended heart failure medication for at least 1 month.
I am clinically stable and not taking certain medications for at least 1 month.
My systolic blood pressure is between 100 and 160 mmHg.
I can walk at least 100 meters.
I understand and can sign informed consent.
You may not be able to join if
I have certain heart conditions that are not allowed.
I have had a stroke or mini-stroke in the past 30 days.
I have received any heart surgery in the past 6 months.
I plan to undergo any surgery in the next 6 months.
I have severe kidney or liver problems.
I am pregnant, breastfeeding, or planning to become pregnant in the next year.
I have participated in other clinical trials in the past 3 months.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Age ≥18, ≤75 years old;
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…
Inclusion Criteria:
1. Age ≥18, ≤75 years old;
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. Any of the following:
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.
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