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Active, Not Recruiting

NCT Number: NCT05629052

TrEatment Approach in the Multimodal Era Registry

The goal of this observational patient registry is to learn how expert centers treat patients with chronic thromboembolic pulmonary hypertension (CTEPH). CTEPH is a condition in which blood clots block the blood vessels in the lungs. There are currently three treatment options for patients with CTEPH:

* surgery to remove blood clots from large vessels in the lungs (pulmonary endarterectomy (PEA)) * the use of a small balloon to unblock smaller blood vessels (balloon pulmonary angioplasty (BPA)) * drugs

Patients can also receive a combination of these treatments.

The main question this registry aims to answer are:

* How many patients receive a given kind of treatment? * How do expert centers combine the different treatments? * Are patients doing better after they receive a given kind of treatment? * How many patients are alive 1, 3 and 5 years after they receive a given kind of treatment?

Participants will receive the same treatments that they would receive if they did not participate in the study. During the study, patients will visit their doctors as they would do normally. The doctors will collect information on the patients' health and enter it into the study database. The follow-up time will be at least 3 years for all patients.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Chronic Thromboembolic Pulmonary Hypertension CTEPH

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario Fundación Favaloro, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Newly referred patient with CTEPH or chronic thromboembolic pulmonary disease (CTEPD) without PH according to the following criteria:
  • Mean pulmonary arterial pressure (mPAP) > 20 mmHg at rest with pulmonary vascular resistance (PVR) > 2 Wood units (WU); or if mPAP ≤ 20 mmHg or PVR ≤ 2 WU at rest, have exercise limitations from CTEPD without PH
  • Abnormal ventilation perfusion scan, pulmonary angiogram, computer tomographic pulmonary angiogram, or magnetic resonance pulmonary angiogram confirming CTEPD as recommended by standard guidelines
  • Treatment with anticoagulation for ≥ 3 months before diagnosis of CTEPH or CTEPD without PH
  • Naïve to interventional treatment (both PEA and BPA)
  • Pre-treatment with PH-specific medication for ≤ 12 months, or no medical pre-treatment, at enrollment
  • Willing and able to provide informed consent in order to participate in the study (informed consent signed)
  • Age ≥ 18 years
  • CTEPH-specific treatment must be modified or initiated at the participating site

Exclusion criteria

  • Main cause of PH other than CTEPH
  • Participating in an interventional clinical trial at enrollment

Treatment and study plan

Pulmonary endarterectomy

Procedure

Surgical removal of a chronic clot from the pulmonary artery

Other names: PEA, Pulmonary thromboendarterectomy (PTE), PTE

Balloon pulmonary angioplasty

Procedure

Catheter-based intervention to dilate occluded pulmonary vessels through the insertion and inflation of a small balloon

Other names: BPA

Pulmonary hypertension (PH)-specific medication

Drug

Treatment with any PH-specific medication, i.e. endothelin receptor antagonists, phosphodiesterase type 5 inhibitors, soluble guanylate cyclase stimulators, drugs acting on the prostanoid pathway and prostaglandin I2 receptor agonists

Primary outcomes

  1. Utilization and combination of treatment modalities

    Time frame: Min. 3 years

    Proportion of patients undergoing a certain type of treatment modality, or a certain combination of modalities

  2. 3-year survival

    Time frame: 3 years after last intervention

    Proportion of patients alive 3 years after the last intervention recorded in the registry, or after start of medical treatment for patients not undergoing any interventional treatment

Secondary outcomes

  1. Complications of treatment interventions (per patient)

    Time frame: Min. 3 years

    Proportion of patients experiencing complications from BPA or PEA

  2. Complications of treatment interventions (per BPA session)

    Time frame: Min. 3 years

    Proportion of BPA sessions associated with complications

  3. 1-year survival

    Time frame: 1 year after last intervention

    Proportion of patients alive 1 year after the last intervention recorded in the registry, or after start of medical treatment for patients not undergoing any interventional treatment

  4. 5-year survival

    Time frame: 5 year after last intervention

    Proportion of patients alive 5 years after the last intervention recorded in the registry, or after start of medical treatment for patients not undergoing any interventional treatment

  5. Changes in PH-specific medication

    Time frame: Min. 3 years

    Proportion of patients experiencing a change in PH-specific medication during the study

  6. Reason why PEA was not performed

    Time frame: Min. 3 years

    The main reason why PEA was not performed as chosen by the investigator from a list of pre-defined reasons

  7. Reason why BPA was not performed

    Time frame: Min. 3 years

    The main reason why BPA was not performed as chosen by the investigator from a list of pre-defined reasons

Other outcomes

  1. Number of unplanned hospitalizations

    Time frame: Min. 3 years

    Proportion of patients experiencing an unplanned hospitalization (i.e. not considering planned hospitalizations for study procedures such as PEA or BPA)

  2. Timing of unplanned hospitalizations

    Time frame: Min. 3 years

    Analysis of the timing of unplanned hospitalization for patients experiencing an unplanned hospitalization (i.e. not considering planned hospitalizations for study procedures such as PEA or BPA)

  3. Frequency of QoL assessment

    Time frame: Min. 3 years

    Proportion of patients undergoing QoL assessment by means of a validated questionnaire during the study

  4. Type of QoL questionnaire

    Time frame: Min. 3 years

    Proportion of patients undergoing QoL assessment using a certain validated questionnaire during the study

Sponsors and collaborators

Lead sponsor

International CTEPH Association

Other

Collaborators

  • Janssen Pharmaceuticals

Registry information

Acronym: TEAM

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Nov 29, 2022
Registry last updated
May 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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