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

Last updated: September 18, 2024
Sponsor: Pulnovo Medical (Wuxi) Co., Ltd.
Overall Status: Active - Recruiting

Phase

3

Condition

Chest Pain

Heart Disease

Scleroderma

Treatment

Guideline-directed medical therapy (GDMT) for heart failure

Pulmonary arterial denervation

Clinical Study ID

NCT05824923
Pulnovo-CO-2022-01
  • Ages 18-75
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥18, ≤75 years old;

  2. Diagnosed with chronic heart failure for at least 3 months, and have received theGDMT pharmacological treatment based on the 2023 ESC Guidelines for Heart Failurefor at least 1 month;

  3. Clinically stable defined by

  4. No intravenous diuretics, inotropes or vasodilators for at least 1 month, and

  5. 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

  6. New York Heart Association (NYHA) class II-IVa;

  7. 6MWD ≥ 100 m and < 450 m;

  8. NT-proBNP > 125 pg/mL (BNP > 35 pg/mL);

  9. Hemodynamic indicators (RHC) :

  10. Mean pulmonary arterial pressure (mPAP) > 20 mmHg

  11. Pulmonary capillary wedge pressure (PCWP) >15 mmHg

  12. Understand and be willing to sign informed consent, and be willing to follow thefollow-up plan required by the protocol.

Exclusion

Exclusion Criteria:

  1. Any of the following:

  2. Hypertrophic cardiomyopathy with left ventricular outflow tract obstruction orsystolic anterior motion; pericardial disease; infiltrative or inflammatorymyocardial disease; valvular stenosis of any of the 4 valves, or severeregurgitation of aortic and pulmonary valves, or active endocarditis; or

  3. Symptomatic carotid stenosis, or transient ischemic attack (TIA) or strokewithin 30 days prior to randomization; or

  4. Untreated congenital heart disease; or

  5. Have received any revascularization, including coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) within 6 months prior torandomization; or anticipated to undergo coronary revascularization (CABG orPCI) within 6 months; or

  6. Artificial pacemakers, including single-chamber, dual-chamber and three-chamberpacemakers, have been implanted or are anticipated to be implanted within 6months; or

  7. Anticipated to undergo ablation of atrial fibrillation within 6 months; or

  8. Anticipated to undergo heart valve surgery (valve replacement, valvuloplasty)within 6 months; or

  9. Listing for heart/heart-lung transplantation or anticipated to implant aventricular assist device (VAD)

  10. Other types of pulmonary hypertension, including WHO Group1, Group3, Group4, Group5;

  11. Received pulmonary arterial hypertension (PAH) targeted drugs within 1 month priorto randomization;

  12. Anticipated to undergo any surgery within 6 months;

  13. The cardiac index (CI) of RHC < 1.5L/min/m²;

  14. Severe renal insufficiency (eGFR <30mL/min/1.73m² by MDRD formula);

  15. Severe liver insufficiency (Child-Pugh classification C);

  16. Platelet count < 50 × 10^9/L;

  17. Life expectancy <1 year;

  18. Systemic inflammation or other disease requiring long-term use of glucocorticoids orimmunosuppressants;

  19. Active infection requiring oral or intravenous antibiotics;

  20. Body mass index (BMI) >40 kg/m²;

  21. Pregnant or lactating women, or plan to pregnant in one year;

  22. Participated in other clinical trials within 3 months prior to signing the informedconsent;

  23. Any other circumstances that investigators deem inappropriate to participate in thistrial.

Study Design

Total Participants: 264
Treatment Group(s): 2
Primary Treatment: Guideline-directed medical therapy (GDMT) for heart failure
Phase: 3
Study Start date:
August 14, 2023
Estimated Completion Date:
February 28, 2027

Study Description

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.

Connect with a study center

  • General Hospital of Northern Theater Command

    Shenyang, Liaoning
    China

    Active - Recruiting

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