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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)

P

Pulnovo Medical

Status

Enrolling

Conditions

Heart Failure
Pulmonary Hypertension

Treatments

Procedure: Pulmonary Artery Denervation

Study type

Interventional

Funder types

Industry

Identifiers

NCT05996562
Pulnovo-CO-2023-01

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Age ≥18, ≤85 years;

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

    1. Mean pulmonary arterial pressure (mPAP) > 20mmHg, and;
    2. Pulmonary capillary wedge pressure (PCWP) >15mmHg.
  3. Chronic heart failure has been diagnosed at least 3 months before screening and have been treated on the GDMT according to 2022 AHA/ACC Guidelines for Heart Failure for at least 1 month;

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

    1. No need of intravenous diuretics, inotropes or vasodilators, and
    2. Systolic blood pressure (SBP) ≥ 100 and < 160 mmHg, and
    3. Resting heart rate (HR) ≥ 50 bpm and <100 bpm (<110 bpm in presence of atrial fibrillation) on the day of the procedure.
  5. NYHA class II-IVa;

  6. 6MWD ≥ 100 m and ≤ 450 m;

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

  8. Understand and be willing to sign informed consent and be strictly willing to follow the protocol.

Exclusion criteria

  1. Any of the following:

    1. Hypertrophic cardiomyopathy with left ventricular (LV) outflow tract obstruction and/or mitral valvular systolic anterior motion (SAM); or
    2. Pericardial disease; or
    3. Infiltrative or inflammatory myocardial disease; or
    4. Valvular heart disease with stenosis or with severe regurgitation; or
    5. Active endocarditis; or
    6. Symptomatic carotid stenosis, or TIA or stroke within 30 days prior to randomization; or
    7. Congenital heart disease; or
    8. Having 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
    9. Artificial pacemakers, including single-chamber, dual-chamber and three-chamber pacemakers, have been implanted less than 6 months or are anticipated to be implanted within 6 months; or
    10. Anticipated to undergo ablation of atrial fibrillation within 6 months; or
    11. Anticipated to undergo heart valve surgery (valve replacement, valvuloplasty) within 6 months; or
    12. Listing for heart/heart-lung transplantation or anticipated to implant a ventricular assist device (VAD)
  2. Received pulmonary arterial hypertension (PAH) targeted drugs within 1 month prior to randomization;

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

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

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

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

  7. Platelet count < 50 × 109/L;

  8. Life expectancy < 1 year;

  9. Systemic inflammation or other disease requiring long-term use of glucocorticoids or immunosuppressants;

  10. Active infection requiring oral or intravenous antibiotics;

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

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

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

  14. Participation in other clinical trials within 3 months prior to signing the informed consent;

  15. Any other circumstances that investigators deemed inappropriate to participate in this trial.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

Pulmonary Artery Denervation (PADN)
Experimental group
Treatment:
Procedure: Pulmonary Artery Denervation

Trial contacts and locations

1

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Central trial contact

Ruben Ramos, Doctor

Data sourced from clinicaltrials.gov

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