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NCT Number: NCT05843500

Chronic Thromboembolic Disease Registry

The goal of this patient registry is to learn about the natural history in patients with chronic thromboembolic disease (CTD) and/or chronic thromboembolic pulmonary hypertension (CTEPH). The main question[s] it aims to answer are:

* Long-term outcome after various types of treatment, including medication, balloon pulmonary angioplasty, and pulmonary endarterectomy * Effect of treatment on patient's quality of life and exercise tolerance Participants will be followed longitudinally to assess their health outcomes and quality of life via chart review and health quality surveys.

Recruiting

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Key information

Conditions

Chronic Thromboembolic Pulmonary Hypertension Chronic Thromboembolic Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients referred with CTED and/or CTEPH defined as:
  • 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 chronic thromboembolic pulmonary disease (CTEPD) without pulmonary hypertension (PH)
  • Radiologic finding of chronic thromboembolic disease, including abnormal ventilation perfusion scan, pulmonary angiogram, computer tomographic pulmonary angiogram, or magnetic resonance pulmonary angiogram
  • Post-embolic exercise intolerance and evidence of chronic thromboembolic disease in the absence of resting pulmonary hypertension
  • Treatment with anticoagulation for ≥ 3 months before diagnosis of CTEPH or CTEPD without PH
  • Age ≥ 18 years

Exclusion criteria

  • Main cause of PH other than World Health Organization (WHO) group 4 (CTEPH)
  • Patient's refusal to participate in clinical research and/or receive intervention

Treatment and study plan

Survey

Other

Patients who received medical, surgical or interventional treatment for chronic thromboembolic pulmonary hypertension will be followed and given quality of life questionnaires.

Primary outcomes

  1. Total number of patients who survive

    Time frame: Through study completion, an average of 5 years

    The total number of patients who are alive

  2. Changes in exercise tolerance

    Time frame: Baseline to end of the study, an average of 5 years

    Measured by 6-min walk test, which will be done approximately every 3 months at follow up per standard of care

  3. Changes in supplemental oxygen use severity

    Time frame: Baseline to end of the study, an average of 5 years

    Number of patients on supplemental oxygen, which will be recorded approximately every 3 months at follow up per standard of care. This will be compiled at the end of the study to provide overall change in measurement.

  4. Changes in New York Heart Association (NYHA) functional class

    Time frame: Baseline to end of the study, an average of 5 years

    Grading of patients by NYHA functional class, which include functional capacity and objective assessment. This will be compiled at the end of the study to provide overall change in measurement.

  5. European Quality of Life Five Dimension (EQ-5D) - Scale Score

    Time frame: Baseline to end of the study, an average of 5 years

    Assessment of quality of life will be measured using EQ-5D-5L. This instrument is a self-assessed, health-related, quality of life questionnaire that measures quality of life on a 5-component scale. The scores range from Level 1 to Level 5, with lower scores indicating a higher quality of life. This will be collected every 3 months and compiled at the end of the study to provide overall change in measurement.

  6. Changes in patients' emPHasis-10 scores

    Time frame: Baseline to end of the study, an average of 5 years

    Assessed by the emPHasis-10 (pulmonary hypertension) instrument, which is an instrument specifically designed to assess the quality of life in patients with pulmonary hypertension. Each item will be scored from 0 to 5 where 0 was the best score. This will be collected every 3 months and compiled at the end of the study to assess overall change in measurement.

  7. Number of patients undergoing lung transplantation

    Time frame: Baseline to end of the study, an average of 5 years

    Number of patients undergoing lung transplantation

Secondary outcomes

  1. Changes in CTEPH-/CTED- specific medication

    Time frame: Baseline to end of the study, an average of 5 years

    The frequency and dose of medication specifically for management of CTEPH or CTED, which will be assessed approximately every 3 months as routine medical follow up. This will be compiled at the end of the study to assess overall change.

  2. History of undergoing pulmonary endarterectomy

    Time frame: Through study completion, an average of 5 years

    Number of patients undergoing pulmonary endarterectomy

  3. History of undergoing pulmonary balloon angioplasty

    Time frame: Through study completion, an average of 5 years

    Number of patients undergoing pulmonary balloon angioplasty

Study contacts

Contact information is provided by the study sponsor or research team.

Miles Conrad, MD

CONTACT

[email protected]

(415) 353-1300

Xiao Wu, MD

CONTACT

[email protected]

628-286-7340

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

Chronic Thromboembolic Disease: A Prospective Registry

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
May 6, 2023
Registry last updated
Jul 14, 2026

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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