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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

Primary Purpose

Pulmonary Hypertension, Heart Failure

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pulmonary Artery Denervation
Sponsored by
Pulnovo Medical (Wuxi) Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Hypertension focused on measuring Pulmonary Artery Denervation, PADN, Pulmonary Hypertension, Heart Failure

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age ≥18, ≤75 years; CpcPH must be confirmed by RHC, defined as: Mean pulmonary arterial pressure (mPAP) > 20mmHg; Pulmonary capillary wedge pressure (PCWP) > 15mmHg; Pulmonary vascular resistance (PVR) > 2WU; 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; Clinically stable HF for at least 1 month, defined as: No need of intravenous diuretics, inotropes or vasodilators, and Systolic blood pressure (SBP) ≥ 100 and < 160 mmHg, and Resting heart rate (HR) ≥ 50 bpm and <100 bpm (<110 bpm in presence of atrial fibrillation) on the day of the procedure. NYHA class II-IVa; 6MWD ≥ 100 m and ≤ 450 m; NT-proBNP > 125pg/mL (or BNP > 35pg/mL); Understand and be willing to sign informed consent and be strictly willing to follow the protocol. Exclusion Criteria: Any of the following: Hypertrophic cardiomyopathy with left ventricular (LV) outflow tract obstruction and/or mitral valvular systolic anterior motion (SAM); or Pericardial disease; or Infiltrative or inflammatory myocardial disease; or Valvular heart disease with stenosis or with severe regurgitation; or Active endocarditis; or Symptomatic carotid stenosis, or TIA or stroke within 30 days prior to randomization; or Congenital heart disease; or 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 Artificial pacemakers, including single-chamber, dual-chamber and three-chamber pacemakers, have been implanted or are anticipated to be implanted within 6 months; or Anticipated to undergo ablation of atrial fibrillation within 6 months; or Anticipated to undergo heart valve surgery (valve replacement, valvuloplasty) within 6 months; or Listing for heart/heart-lung transplantation or anticipated to implant a ventricular assist device (VAD) Received pulmonary arterial hypertension (PAH) targeted drugs within 1 month prior to randomization; Anticipated to undergo any surgery within the next 6 months; Cardiac index (CI) measured by RHC < 1.5L/min/m2; Severe renal insufficiency (eGFR < 30mL/min/1.73m2 by MDRD formula); Severe liver insufficiency (Child-Pugh classification B-C); Platelet count < 50 × 109/L; Life expectancy < 1 year; Systemic inflammation or other disease requiring long-term use of glucocorticoids or immunosuppressants; Active infection requiring oral or intravenous antibiotics; Cannot tolerate warfarin, aspirin, clopidogrel, and any of GDMT medicines; Body mass index (BMI) > 40 kg/m²; Pregnant or lactating women, or planning to be pregnant within one year; Participation in other clinical trials within 3 months prior to signing the informed consent; Any other circumstances that investigators deemed inappropriate to participate in this trial.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Pulmonary Artery Denervation (PADN)

    Arm Description

    Outcomes

    Primary Outcome Measures

    6-minute walk distance (6MWD) difference
    The primary endpoint is change in 6-min-walk distance (6-MWD) from baseline to 6months.

    Secondary Outcome Measures

    Full Information

    First Posted
    July 25, 2023
    Last Updated
    August 13, 2023
    Sponsor
    Pulnovo Medical (Wuxi) Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05996562
    Brief Title
    Study for Evaluation of Safety and Efficacy of PADN to Treat Combined Post- and Pre- Capillary Pulmonary Hypertension Associated With Chronic Heart Failure
    Official Title
    Study for Evaluation of Safety and Efficacy of Pulmonary Artery Denervation to Treat Combined Post- and Pre- Capillary Pulmonary Hypertension Associated With Chronic Heart Failure: A Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 2023 (Anticipated)
    Primary Completion Date
    June 2024 (Anticipated)
    Study Completion Date
    December 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Pulnovo Medical (Wuxi) Co., Ltd.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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 (CpcPH) associated with chronic heart failure(CHF). 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pulmonary Hypertension, Heart Failure
    Keywords
    Pulmonary Artery Denervation, PADN, Pulmonary Hypertension, Heart Failure

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    15 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Pulmonary Artery Denervation (PADN)
    Arm Type
    Experimental
    Intervention Type
    Procedure
    Intervention Name(s)
    Pulmonary Artery Denervation
    Intervention Description
    Contrast pulmonary artery (PA) angiography will be performed to localize the pulmonary artery bifurcation level and calculate the PA diameter. Once the anatomy deemed acceptable, the radiofrequency ablation catheter will be introduced into ostium of the left PA and the distal bifurcation area of the main PA. The catheter will be manoeuvred within the PA to allow energy delivery in a circumferential manner to ensure that the electrodes are tightly in contact with the endovascular surface. About three ablations at 45-55°C for 120 seconds each will be performed in ostium of the left PA and the distal bifurcation area of the main PA.
    Primary Outcome Measure Information:
    Title
    6-minute walk distance (6MWD) difference
    Description
    The primary endpoint is change in 6-min-walk distance (6-MWD) from baseline to 6months.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age ≥18, ≤75 years; CpcPH must be confirmed by RHC, defined as: Mean pulmonary arterial pressure (mPAP) > 20mmHg; Pulmonary capillary wedge pressure (PCWP) > 15mmHg; Pulmonary vascular resistance (PVR) > 2WU; 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; Clinically stable HF for at least 1 month, defined as: No need of intravenous diuretics, inotropes or vasodilators, and Systolic blood pressure (SBP) ≥ 100 and < 160 mmHg, and Resting heart rate (HR) ≥ 50 bpm and <100 bpm (<110 bpm in presence of atrial fibrillation) on the day of the procedure. NYHA class II-IVa; 6MWD ≥ 100 m and ≤ 450 m; NT-proBNP > 125pg/mL (or BNP > 35pg/mL); Understand and be willing to sign informed consent and be strictly willing to follow the protocol. Exclusion Criteria: Any of the following: Hypertrophic cardiomyopathy with left ventricular (LV) outflow tract obstruction and/or mitral valvular systolic anterior motion (SAM); or Pericardial disease; or Infiltrative or inflammatory myocardial disease; or Valvular heart disease with stenosis or with severe regurgitation; or Active endocarditis; or Symptomatic carotid stenosis, or TIA or stroke within 30 days prior to randomization; or Congenital heart disease; or 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 Artificial pacemakers, including single-chamber, dual-chamber and three-chamber pacemakers, have been implanted or are anticipated to be implanted within 6 months; or Anticipated to undergo ablation of atrial fibrillation within 6 months; or Anticipated to undergo heart valve surgery (valve replacement, valvuloplasty) within 6 months; or Listing for heart/heart-lung transplantation or anticipated to implant a ventricular assist device (VAD) Received pulmonary arterial hypertension (PAH) targeted drugs within 1 month prior to randomization; Anticipated to undergo any surgery within the next 6 months; Cardiac index (CI) measured by RHC < 1.5L/min/m2; Severe renal insufficiency (eGFR < 30mL/min/1.73m2 by MDRD formula); Severe liver insufficiency (Child-Pugh classification B-C); Platelet count < 50 × 109/L; Life expectancy < 1 year; Systemic inflammation or other disease requiring long-term use of glucocorticoids or immunosuppressants; Active infection requiring oral or intravenous antibiotics; Cannot tolerate warfarin, aspirin, clopidogrel, and any of GDMT medicines; Body mass index (BMI) > 40 kg/m²; Pregnant or lactating women, or planning to be pregnant within one year; Participation in other clinical trials within 3 months prior to signing the informed consent; Any other circumstances that investigators deemed inappropriate to participate in this trial.

    12. IPD Sharing Statement

    Learn more about this trial

    Study for Evaluation of Safety and Efficacy of PADN to Treat Combined Post- and Pre- Capillary Pulmonary Hypertension Associated With Chronic Heart Failure

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