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

August 13, 2023 updated by: Pulnovo Medical (Wuxi) Co., Ltd.

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥18, ≤75 years;

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

    1. Mean pulmonary arterial pressure (mPAP) > 20mmHg;
    2. Pulmonary capillary wedge pressure (PCWP) > 15mmHg;
    3. Pulmonary vascular resistance (PVR) > 2WU;
  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 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pulmonary Artery Denervation (PADN)
Procedure: Pulmonary Artery Denervation

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6-minute walk distance (6MWD) difference
Time Frame: 6 months
The primary endpoint is change in 6-min-walk distance (6-MWD) from baseline to 6months.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pulnovo Medical (Wuxi) Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2023

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

July 25, 2023

First Submitted That Met QC Criteria

August 13, 2023

First Posted (Actual)

August 18, 2023

Study Record Updates

Last Update Posted (Actual)

August 18, 2023

Last Update Submitted That Met QC Criteria

August 13, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pulnovo-CO-2023-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Failure

Clinical Trials on Pulmonary Artery Denervation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bangladesh

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe