NCT06209710

Brief Summary

This clinical trial investigates new treatment approaches for chronic thromboembolic pulmonary hypertension (CTEPH), a condition affecting the lungs' blood vessels. CTEPH often develops after repeated blood clots in the lungs, leading to increased pressure and strain on the heart. The study aims to assess the effectiveness of combining two treatments, balloon pulmonary angioplasty (BPA) and pulmonary artery denervation (PADN), in reducing blood pressure in the lungs compared to the standard treatment. Additionally, the trial will explore the impact of these treatments on patients' quality of life. The hope is to improve outcomes and provide valuable insights into managing this challenging condition.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 17, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

April 2, 2024

Status Verified

April 1, 2024

Enrollment Period

1.3 years

First QC Date

January 4, 2024

Last Update Submit

April 1, 2024

Conditions

Chronic Thromboembolic Pulmonary Hypertension

Keywords

Balloon pulmonary angioplastyPulmonary artery denervationCTEPH

Outcome Measures

Primary Outcomes (1)

  • Change in mean Pulmonary Arterial Pressure (mPAP)

    Measure the change in mPAP from baseline to 3 months post-intervention to assess the effectiveness of the combined BPA and PADN therapy.

    3 months

Secondary Outcomes (5)

  • Quality of Life Assessment

    3 months, and 1 year

  • Physical Functionality Assessment

    3 months, and 1 year

  • Hemodynamic Response Assessment

    1 year

  • Adverse Events

    3 months, abd 1 year

  • Survival Rates

    1 year

Study Arms (2)

Intervention Arm: BPA + PADN + Standard Drug Therapy

EXPERIMENTAL

Participants in this arm will undergo the combination of Balloon Pulmonary Angioplasty (BPA) and Pulmonary Artery Denervation (PADN) procedures.

Procedure: Balloon Pulmonary Angioplasty combined with Pulmonary Artery Denervation

Control Arm: BPA + Sham PADN + Standard Drug Therapy

SHAM COMPARATOR

Participants in this arm will receive the combination of Balloon Pulmonary Angioplasty (BPA) and standard drug therapy as the control group. Similar to the intervention arm, a denervation catheter will be placed in the same anatomical position, but no further denervation intervention will be performed.

Procedure: Balloon Pulmonary Angioplasty with Sham Pulmonary Artery Denervation

Interventions

Balloon Pulmonary Angioplasty combined with Pulmonary Artery DenervationPROCEDURE

Participants in the intervention arm will undergo a combination of Balloon Pulmonary Angioplasty (BPA) and Pulmonary Artery Denervation (PADN), as part of this phase 2/3 clinical trial. The trial aims to determine the optimal number of radiofrequency (RF) ablation points required for effective PADN based on pulmonary artery size or diameter. The BPA procedure addresses segmental and subsegmental thrombi masses through pulmonary artery dilation, while the PADN procedure involves the placement of a denervation catheter near the bifurcation of the main pulmonary artery. RF energy is selectively applied, and ablation points are determined based on individual patient characteristics and expected therapeutic effects. This unique approach seeks to customize the intervention to the patient's specific pulmonary anatomy, contributing to the overall effectiveness of the treatment strategy.

Intervention Arm: BPA + PADN + Standard Drug Therapy
Balloon Pulmonary Angioplasty with Sham Pulmonary Artery DenervationPROCEDURE

Participants receive Balloon Pulmonary Angioplasty (BPA) combined with a sham Pulmonary Artery Denervation (PADN) procedure. The sham PADN involves catheter placement mimicking the actual procedure without the application of radiofrequency energy

Control Arm: BPA + Sham PADN + Standard Drug Therapy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent.
  • Age 18 - 80 years.
  • Diagnosis of chronic thromboembolic heart disease.
  • Mean pulmonary arterial pressure (mPAP) \>20 mmHg.
  • Pulmonary vascular resistance \>3 Wood units.
  • Presence of organized thrombus masses.
  • World Health Organization (WHO) functional class II to IV.

You may not qualify if:

  • Proximal organized thrombotic masses not suitable for Balloon Pulmonary Angioplasty (BPA) and Pulmonary Artery Denervation (PADN).
  • WHO functional class I
  • Additionally, participants can be excluded from the trial under the following circumstances:
  • Withdrawal of consent at any time.
  • Failure to complete the treatment as per protocols.
  • Protocol violations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Military Medical Academy

Belgrade, 11000, Serbia

Location

Related Publications (2)

  • Chen SL, Zhang FF, Xu J, Xie DJ, Zhou L, Nguyen T, Stone GW. Pulmonary artery denervation to treat pulmonary arterial hypertension: the single-center, prospective, first-in-man PADN-1 study (first-in-man pulmonary artery denervation for treatment of pulmonary artery hypertension). J Am Coll Cardiol. 2013 Sep 17;62(12):1092-1100. doi: 10.1016/j.jacc.2013.05.075. Epub 2013 Jul 10.

    PMID: 23850902BACKGROUND

  • Zhang H, Wei Y, Zhang C, Yang Z, Kan J, Gu H, Fan F, Gu H, Wang Q, Xie D, Zhang G, Guo X, Yin Y, Jin B, Zhou H, Yang Z, Wang Z, Xin Y, Zhang C, Meng L, Wang X, Sun J, Zhao C, Zhang J, Yan X, Chen F, Yao C, Stone GW, Chen SL. Pulmonary Artery Denervation for Pulmonary Arterial Hypertension: A Sham-Controlled Randomized PADN-CFDA Trial. JACC Cardiovasc Interv. 2022 Dec 12;15(23):2412-2423. doi: 10.1016/j.jcin.2022.09.013. Epub 2022 Sep 18.

    PMID: 36121246BACKGROUND

Study Officials

  • Slobodan Obradovic, MD, PhD

    Clinic of Cardiology, Military Medical Academy, Belgrade, Serbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Intervention Group: Patients assigned to this group undergo a combination of Balloon Pulmonary Angioplasty (BPA) and Pulmonary Artery Denervation (PADN) alongside standard drug therapy. Control Group: Patients in this group receive Balloon Pulmonary Angioplasty (BPA), Sham Pulmonary Denervation and standard drug therapy.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr. Boris Dzudovic, MD, PhD, Teaching Assistant at Medical School, University of Defense

Study Record Dates

First Submitted

January 4, 2024

First Posted

January 17, 2024

Study Start

April 1, 2024

Primary Completion

August 1, 2025

Study Completion

December 1, 2025

Last Updated

April 2, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will share

We intend to share de-identified individual participant data, excluding any personally identifiable information (PII), to protect participant privacy. Data sharing is planned to commence after the completion of the trial and the release of the main study results. The exact timing for data sharing will be in compliance with regulatory requirements and ethical considerations. Access to the shared data will be granted to researchers who submit formal requests outlining their research objectives, methodologies, and plans for data usage. A data sharing agreement will be established to ensure adherence to ethical standards and protection of participant confidentiality. Data will be shared in a standardized and machine-readable format, allowing for compatibility with various statistical analysis tools and software. The study team is committed to providing necessary documentation and support to facilitate the appropriate use and interpretation of the shared data.

Shared Documents
STUDY PROTOCOL, ICF, CSR
Time Frame
Data sharing is planned to commence after the completion of the trial and the release of the main study results. The exact timing for data sharing will be in compliance with regulatory requirements and ethical considerations.
Access Criteria
Access to the shared data will be granted to researchers who submit formal requests outlining their research objectives, methodologies, and plans for data usage. A data sharing agreement will be established to ensure adherence to ethical standards and protection of participant confidentiality.

Locations

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