A Trial to Evaluate the Safety and Efficacy of Pulmonary Artery Denervation for the Treatment of Pulmonary Hypertension Associated With Left Heart Failure

Launched by PULNOVO MEDICAL (WUXI) CO., LTD. · Apr 10, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called pulmonary artery denervation (PADN) for patients with heart failure who also have pulmonary hypertension, which is high blood pressure in the lungs. The goal is to see if this treatment is safe and effective in improving the health of patients with these conditions. The trial is currently recruiting participants aged 18 to 75 who have been diagnosed with chronic heart failure and have been on standard medication for at least a month. Other important criteria include being stable without certain medications for at least a month and having specific heart and lung pressure readings.

Participants in this trial can expect to receive the PADN treatment, which involves a procedure to help lower lung pressure, and they will be closely monitored throughout the study. It's important to note that certain individuals, such as those with severe heart conditions, recent surgeries, or specific health issues, may not be eligible to join the trial. This study aims to provide more insight into how PADN could help improve the quality of life for those facing these challenging heart and lung conditions.

Gender

ALL

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, 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.