Study for Evaluation of Safety and Efficacy of PADN to Treat Combined Post- and Pre- Capillary Pulmonary Hypertension Associated with Chronic Heart Failure(PADN-CpcPH-PILOT)

Last updated: October 7, 2024
Sponsor: Pulnovo Medical (Wuxi) Co., Ltd.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Failure

Circulation Disorders

Heart Disease

Treatment

Pulmonary Artery Denervation

Clinical Study ID

NCT05996562
Pulnovo-CO-2023-01
  • Ages 18-85
  • All Genders

Study Summary

The goal of this pilot study is to evaluate the safety and efficacy of pulmonary artery denervation (PADN) in Combined Post- and Pre- Capillary Pulmonary Hypertension Associated with Chronic Heart Failure.

Participants who have received guideline-directed medical therapy (GDMT) according to 2022 AHA/ACC Guidelines for Heart Failure (HF) and have been clinically stable for at least 1 month, will be treated with PADN and followed for 1 year.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥18, ≤85 years;

  2. PH must be confirmed by RHC, defined as:

  3. Mean pulmonary arterial pressure (mPAP) > 20mmHg, and;

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

  5. Chronic heart failure has been diagnosed at least 3 months before screening and havebeen treated on the GDMT according to 2022 AHA/ACC Guidelines for Heart Failure forat least 1 month;

  6. Clinically stable HF for at least 1 month, defined as:

  7. No need of intravenous diuretics, inotropes or vasodilators, and

  8. Systolic blood pressure (SBP) ≥ 100 and < 160 mmHg, and

  9. Resting heart rate (HR) ≥ 50 bpm and <100 bpm (<110 bpm in presence ofatrial fibrillation) on the day of the procedure.

  10. NYHA class II-IVa;

  11. 6MWD ≥ 100 m and ≤ 450 m;

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

  13. Understand and be willing to sign informed consent and be strictly willing to followthe protocol.

Exclusion

Exclusion Criteria:

  1. Any of the following:

  2. Hypertrophic cardiomyopathy with left ventricular (LV) outflow tractobstruction and/or mitral valvular systolic anterior motion (SAM); or

  3. Pericardial disease; or

  4. Infiltrative or inflammatory myocardial disease; or

  5. Valvular heart disease with stenosis or with severe regurgitation; or

  6. Active endocarditis; or

  7. Symptomatic carotid stenosis, or TIA or stroke within 30 days prior torandomization; or

  8. Congenital heart disease; or

  9. Having received any revascularization, including coronary artery bypassgrafting (CABG) or percutaneous coronary intervention (PCI) within 6 monthsprior to randomization; or anticipated to undergo coronary revascularization (CABG or PCI) within 6 months; or

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

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

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

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

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

  15. Anticipated to undergo any surgery within the next 6 months;

  16. Cardiac index (CI) measured by RHC < 1.5L/min/m2;

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

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

  19. Platelet count < 50 × 109/L;

  20. Life expectancy < 1 year;

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

  22. Active infection requiring oral or intravenous antibiotics;

  23. Cannot tolerate warfarin, aspirin, clopidogrel, and any of GDMT medicines;

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

  25. Pregnant or lactating women, or planning to be pregnant within one year;

  26. Participation in other clinical trials within 3 months prior to signing the informedconsent;

  27. Any other circumstances that investigators deemed inappropriate to participate inthis trial.

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Pulmonary Artery Denervation
Phase:
Study Start date:
June 28, 2024
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • Hospital de Santa Marta

    Lisbon,
    Portugal

    Active - Recruiting

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