Chronic Thromboembolic Disease Registry

Chronic Thromboembolic Pulmonary Hypertension Clinical Trial

Official title:

Chronic Thromboembolic Disease: A Prospective Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05843500
• Other study ID #: 23-38534
• Status: Recruiting
• Start date: August 1, 2023
• Est. completion date: July 1, 2028

Study information

• Verified date: August 2023
• Source: University of California, San Francisco
• Contact: Miles Conrad, MD
• Phone: (415) 353-1300
• Email: miles.conrad[@]ucsf.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 1, 2028
• Est. primary completion date: July 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Thromboembolic Pulmonary Hypertension
• Hypertension, Pulmonary
• Thromboembolism

Intervention

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

Locations

Country	Name	City	State
United States	University of California San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total number of patients who survive	The total number of patients who are alive	Through study completion, an average of 5 years
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Number of patients undergoing lung transplantation	Number of patients undergoing lung transplantation	Baseline to end of the study, an average of 5 years
Secondary	Changes in CTEPH-/CTED- specific medication	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.	Baseline to end of the study, an average of 5 years
Secondary	History of undergoing pulmonary endarterectomy	Number of patients undergoing pulmonary endarterectomy	Through study completion, an average of 5 years
Secondary	History of undergoing pulmonary balloon angioplasty	Number of patients undergoing pulmonary balloon angioplasty	Through study completion, an average of 5 years