NCT05824923

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
264

participants targeted

Target at P50-P75 for phase_3

Timeline
9mo left

Started Aug 2023

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Aug 2023Feb 2027

First Submitted

Initial submission to the registry

January 10, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 24, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

August 14, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Expected
Last Updated

September 20, 2024

Status Verified

September 1, 2024

Enrollment Period

2 years

First QC Date

January 10, 2023

Last Update Submit

September 18, 2024

Conditions

Pulmonary HypertensionHeart Failure With Reduced Ejection FractionHypertensionVascular DiseasesCardiovascular DiseasesHeart FailureHeart Failure With Preserved Ejection FractionHeart Failure With Mid Range Ejection Fraction

Keywords

Pulmonary Artery DenervationPulmonary Hypertension Due to Left Heart DiseaseHeart Failurepulmonary hypertensionleft heart failure

Outcome Measures

Primary Outcomes (1)

  • Clinical Worsening, defined as the occurrence of any of the followings:

    1. Requiring intravenous medication (inotropes, diuretics or vasodilators) due to worsening of heart failure 2. Rehospitalization due to heart failure 3. 6MWD decreased by \> 10% or \> 30m compared with baseline 4. Referral for heart/heart-lung transplantation 5. All-cause death

    immediately after the randomization to the last enrolled subject having at least 6 months follow-up

Secondary Outcomes (15)

  • Parameters measured by transthoracic echocardiography(TTE)

    6 months, 1 year, 3 years

  • Parameters measured by transthoracic echocardiography(TTE)

    6 months, 1 year, 3 years

  • Parameters measured by transthoracic echocardiography(TTE)

    6 months, 1 year, 3 years

  • Parameters measured by transthoracic echocardiography(TTE)

    6 months, 1 year, 3 years

  • Parameters measured by transthoracic echocardiography(TTE)

    6 months, 1 year, 3 years

  • +10 more secondary outcomes

Other Outcomes (2)

  • Safety Outcome: AESI

    within 30 days after the procedure

  • Safety Outcome: AE and SAE

    throughout the clincialtrial

Study Arms (2)

Pulmonary Artery Denervation (PADN)

EXPERIMENTAL

Patients in the PADN group will receive pulmonary artery denervation procedure.

Procedure: Pulmonary arterial denervationDrug: Guideline-directed medical therapy (GDMT) for heart failure

Guideline-directed medical therapy (GDMT) for heart failure

ACTIVE COMPARATOR

Patients in the control group will take their baseline anti-heart failure medications at the original doses according to 2023 ESC Guidelines for heart failure, without any changes except when medically required. The anti-heart failure drugs treatment is consistent in both arms.

Drug: Guideline-directed medical therapy (GDMT) for heart failure

Interventions

Pulmonary arterial denervationPROCEDURE

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 ℃ for 120 seconds each will be performed in ostium of the left PA and the distal bifurcation area of the main PA. For non-atrial fibrillation patients, dual antiplatelet therapy for 1 month after PADN is recommended. Patients with atrial fibrillation should continue new oral anticoagulants and patients who underwent metal valve replacement should continued oral warfarin anticoagulation according to guidelines, which could determined by the physician.

Also known as: PADN
Pulmonary Artery Denervation (PADN)
Guideline-directed medical therapy (GDMT) for heart failureDRUG

GDMT medication recommendation including: * Angiotensin-converting enzyme inhibitor (ACEI) or angiotensin-receptor blocker (ARB) or angiotensin receptor-neprilysin inhibitor (ARNI) * Beta-receptor blocker (BB) * Mineralocorticoid receptor antagonist (MRA) * Sodium-glucose co-transporter 2 (SGLT2) inhibitor * Diuretics The medication regimen (type and dosage) will be the investigator's discretion in accordance with the 2023 ESC Guidelines for Heart Failure. The type and dosage of all GDMT medications (except for diuretics) should remain unchanged through follow-up duration (at 12-month visit), unless the participant's conditions need adjust of GDMT regimens. Dosage and single or combination of diuretics are all left at physician's discretion.

Also known as: GDMT medication for heart failure
Guideline-directed medical therapy (GDMT) for heart failurePulmonary Artery Denervation (PADN)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18, ≤75 years old;
  • Diagnosed with chronic heart failure for at least 3 months, and have received the GDMT pharmacological treatment based on the 2023 ESC Guidelines for Heart Failure for at least 1 month;
  • Clinically stable defined by
  • No intravenous diuretics, inotropes or vasodilators for at least 1 month, and
  • 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
  • New York Heart Association (NYHA) class II-IVa;
  • MWD ≥ 100 m and \< 450 m;
  • NT-proBNP \> 125 pg/mL (BNP \> 35 pg/mL);
  • Hemodynamic indicators (RHC) :
  • Mean pulmonary arterial pressure (mPAP) \> 20 mmHg
  • Pulmonary capillary wedge pressure (PCWP) \>15 mmHg
  • Understand and be willing to sign informed consent, and be willing to follow the follow-up plan required by the protocol.

You may not qualify if:

  • Any of the following:
  • Hypertrophic cardiomyopathy with left ventricular outflow tract obstruction or systolic anterior motion; pericardial disease; infiltrative or inflammatory myocardial disease; valvular stenosis of any of the 4 valves, or severe regurgitation of aortic and pulmonary valves, or active endocarditis; or
  • Symptomatic carotid stenosis, or transient ischemic attack (TIA) or stroke within 30 days prior to randomization; or
  • Untreated congenital heart disease; or
  • Have 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)
  • Other types of pulmonary hypertension, including WHO Group1, Group3, Group4, Group5;
  • Received pulmonary arterial hypertension (PAH) targeted drugs within 1 month prior to randomization;
  • Anticipated to undergo any surgery within 6 months;
  • The cardiac index (CI) of RHC \< 1.5L/min/m²;
  • Severe renal insufficiency (eGFR \<30mL/min/1.73m² by MDRD formula);
  • Severe liver insufficiency (Child-Pugh classification C);
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital of Northern Theater Command

Shenyang, Liaoning, China

RECRUITING

MeSH Terms

Conditions

Hypertension, PulmonaryHypertensionVascular DiseasesCardiovascular DiseasesHeart Failure

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHeart Diseases

Study Officials

  • Yaling Han

    The General Hospital of Northern Theater Command

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark Gu

CONTACT

13774217349guwen@pulnovomed.com

Yanyan Lu

CONTACT

13914766820co@pulnovomed.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: At the 12-months visit, participants in the control group who still meet the inclusion and exclusion criteria can choose to receive PADN procedure.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2023

First Posted

April 24, 2023

Study Start

August 14, 2023

Primary Completion

August 1, 2025

Study Completion (Estimated)

February 1, 2027

Last Updated

September 20, 2024

Record last verified: 2024-09

Locations

CN(1)