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Recruiting NCT05843500

Chronic Thromboembolic Disease Registry

— Observational Chronic Thromboembolic Pulmonary Hypertension Chronic Thromboembolic Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Survey.
Who it may be relevant to
Registry conditions: Chronic Thromboembolic Pulmonary Hypertension, Chronic Thromboembolic Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Chronic Thromboembolic Disease: A Prospective Registry

Overview

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.

Interventions

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

Primary outcome measures

  • Total number of patients who survive [Time frame: Through study completion, an average of 5 years]
  • Changes in exercise tolerance [Time frame: Baseline to end of the study, an average of 5 years]
  • Changes in supplemental oxygen use severity [Time frame: Baseline to end of the study, an average of 5 years]
  • Changes in New York Heart Association (NYHA) functional class [Time frame: Baseline to end of the study, an average of 5 years]
  • European Quality of Life Five Dimension (EQ-5D) - Scale Score [Time frame: Baseline to end of the study, an average of 5 years]
  • Changes in patients' emPHasis-10 scores [Time frame: Baseline to end of the study, an average of 5 years]
  • Number of patients undergoing lung transplantation [Time frame: Baseline to end of the study, an average of 5 years]
Secondary outcome measures (3)
  • Changes in CTEPH-/CTED- specific medication [Time frame: Baseline to end of the study, an average of 5 years]
  • History of undergoing pulmonary endarterectomy [Time frame: Through study completion, an average of 5 years]
  • History of undergoing pulmonary balloon angioplasty [Time frame: Through study completion, an average of 5 years]

Eligibility criteria

Inclusion criteria

  • 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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • University of California San Francisco — San Francisco

Identifiers

NCT: NCT05843500 · 23-38534

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗