Chronic Thromboembolic Disease Registry

NCT05843500 | Recruiting

• 1 other identifier: 23-38534
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Thromboembolic Pulmonary Hypertension; Chronic Thromboembolic Disease

Outcome Measures

Primary Outcomes (7)

• Total number of patients who survive

  The total number of patients who are alive

  Through study completion, an average of 5 years

• Changes in exercise tolerance

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

  Baseline to end of the study, an average of 5 years

• Changes in supplemental oxygen use severity

  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.

  Baseline to end of the study, an average of 5 years

• Changes in New York Heart Association (NYHA) functional class

  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.

  Baseline to end of the study, an average of 5 years

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

  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.

  Baseline to end of the study, an average of 5 years

• Changes in patients' emPHasis-10 scores

  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.

  Baseline to end of the study, an average of 5 years

• Number of patients undergoing lung transplantation

  Number of patients undergoing lung transplantation

  Baseline to end of the study, an average of 5 years

Secondary Outcomes (3)

• Changes in CTEPH-/CTED- specific medication

  Baseline to end of the study, an average of 5 years

• History of undergoing pulmonary endarterectomy

  Through study completion, an average of 5 years

• History of undergoing pulmonary balloon angioplasty

  Through study completion, an average of 5 years

Study Arms (1)

Chronic thromboembolic disease

Patients with chronic thromboembolic disease/pulmonary hypertension

Other: Survey

Interventions

Survey OTHER

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

Chronic thromboembolic disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with diagnosed chronic thromboembolic disease (CTED) or chronic thromboembolic pulmonary hypertension (CTEPH)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California San Francisco

San Francisco, California, 94143, United States

RECRUITING

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Miles Conrad, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Miles Conrad, MD

CONTACT

(415) 353-1300; miles.conrad@ucsf.edu

Xiao Wu, MD

CONTACT

628-286-7340; xiao.wu@ucsf.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 6, 2023
• Study Start: August 1, 2023
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)