Chronic Thromboembolic Disease Registry
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of California, San Francisco
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Patients with diagnosed chronic thromboembolic disease (CTED) or chronic thromboembolic pulmonary hypertension (CTEPH)
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Survey
Other interventionPatients who received medical, surgical or interventional treatment for chronic thromboembolic pulmonary hypertension will be followed and given quality of life questionnaires.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Chronic thromboembolic disease1 intervention
Trial outcomes
Primary outcomes
1
Total number of patients who survive
The total number of patients who are alive
Time frame
Through study completion, an average of 5 years2
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
Time frame
Baseline to end of the study, an average of 5 years3
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.
Time frame
Baseline to end of the study, an average of 5 years4
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.
Time frame
Baseline to end of the study, an average of 5 yearsSecondary outcomes
1
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.
Time frame
Baseline to end of the study, an average of 5 years2
History of undergoing pulmonary endarterectomy
Number of patients undergoing pulmonary endarterectomy
Time frame
Through study completion, an average of 5 years3
History of undergoing pulmonary balloon angioplasty
Number of patients undergoing pulmonary balloon angioplasty
Time frame
Through study completion, an average of 5 yearsSponsors and contacts
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Source ClinicalTrials.gov