Clinical trial NCT05843500: Chronic Thromboembolic Disease Registry
Official title: Chronic Thromboembolic Disease: A Prospective Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Thromboembolic Pulmonary Hypertension
Chronic Thromboembolic Disease
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with diagnosed chronic thromboembolic disease (CTED) or chronic thromboembolic pulmonary hypertension (CTEPH)

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.


Eligibility criteria: 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

Primary outcomes:
measure: Total number of patients who survive
timeFrame: Through study completion, an average of 5 years
measure: Changes in exercise tolerance
timeFrame: Baseline to end of the study, an average of 5 years
measure: Changes in supplemental oxygen use severity
timeFrame: Baseline to end of the study, an average of 5 years
measure: Changes in New York Heart Association (NYHA) functional class
timeFrame: Baseline to end of the study, an average of 5 years
measure: European Quality of Life Five Dimension (EQ-5D) - Scale Score
timeFrame: Baseline to end of the study, an average of 5 years
measure: Changes in patients' emPHasis-10 scores
timeFrame: Baseline to end of the study, an average of 5 years
measure: Number of patients undergoing lung transplantation
timeFrame: Baseline to end of the study, an average of 5 years
Secondary outcomes:
measure: Changes in CTEPH-/CTED- specific medication
timeFrame: Baseline to end of the study, an average of 5 years
measure: History of undergoing pulmonary endarterectomy
timeFrame: Through study completion, an average of 5 years
measure: History of undergoing pulmonary balloon angioplasty
timeFrame: Through study completion, an average of 5 years
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Miles Conrad, MD
role: PRINCIPAL_INVESTIGATOR
References: