Chronic Thromboembolic Disease Registry

Recruiting

• Conditions: Chronic Thromboembolic Pulmonary Hypertension; Chronic Thromboembolic Disease
• Interventions: Other: Survey

• Registration Number: NCT05843500
• Lead Sponsor: University of California, San Francisco

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-24
• Study First Submitted QC: 2023-04-24
• Study First Posted: 2023-05-06
• Status Verified: 2023-08
• Study Start: 2023-08-01
• Last Update Submitted: 2023-08-14
• Last Update Posted: 2023-08-18
• Primary Completion: 2028-07-01
• Study Completion: 2028-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients referred with CTED and/or CTEPH defined as:

  1. 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)
  2. Radiologic finding of chronic thromboembolic disease, including abnormal ventilation perfusion scan, pulmonary angiogram, computer tomographic pulmonary angiogram, or magnetic resonance pulmonary angiogram
  3. 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chronic thromboembolic disease	Survey	Patients with chronic thromboembolic disease/pulmonary hypertension

Primary Outcome Measures

Name	Time	Method
Number of patients undergoing lung transplantation	Baseline to end of the study, an average of 5 years	Number of patients undergoing lung transplantation
Total number of patients who survive	Through study completion, an average of 5 years	The total number of patients who are alive
Changes in exercise tolerance	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
Changes in New York Heart Association (NYHA) functional class	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.
Changes in supplemental oxygen use severity	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.
European Quality of Life Five Dimension (EQ-5D) - Scale Score	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.
Changes in patients' emPHasis-10 scores	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.

Secondary Outcome Measures

Name	Time	Method
Changes in CTEPH-/CTED- specific medication	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.
History of undergoing pulmonary endarterectomy	Through study completion, an average of 5 years	Number of patients undergoing pulmonary endarterectomy
History of undergoing pulmonary balloon angioplasty	Through study completion, an average of 5 years	Number of patients undergoing pulmonary balloon angioplasty

Trial Locations

Locations (1)

University of California San Francisco; 🇺🇸 San Francisco, California, United States