Zapping lung nerves could ease heart Failure-Related high blood pressure
NCT ID NCT05824923
First seen Jul 21, 2026 · Last updated Jul 22, 2026 · Updated 1 time
Summary
This trial tests a procedure called pulmonary arterial denervation (PADN) for people with heart failure who also have high blood pressure in the lungs. A special catheter delivers radiofrequency energy to nerves in the pulmonary artery, which may help lower pressure and improve heart function. The study includes 264 adults aged 18–75 with chronic heart failure and confirmed pulmonary hypertension. Researchers will track whether the procedure reduces hospitalizations, need for IV medications, or death.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a ring-shaped catheter that delivers radiofrequency energy to nerves in the pulmonary artery, a procedure called pulmonary arterial denervation (PADN)
- What this could lead to
- If successful, this procedure could offer a new treatment option for heart failure patients with pulmonary hypertension, potentially reducing hospitalizations and improving survival.
- What could go wrong
- This is an early-phase trial with 264 participants, so results may not apply to all patients. The procedure carries risks such as vessel damage, arrhythmia, or worsening heart failure.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 264 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2023
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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General Hospital of Northern Theater Command
Shenyang, Liaoning, China
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