Recruiting

Observational Study

Sponsor:

UCLA

Code:

NCT05843500

Conditions

Chronic Thromboembolic Pulmonary Hypertension

Chronic Thromboembolic Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Survey

Study Details

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.

Conditions

Chronic Thromboembolic Pulmonary Hypertension

Chronic Thromboembolic Disease

Study ID

NCT05843500

Start date

Aug 1, 2023

Status verified date

Jul, 2026

Completion date

Jul 1, 2028

Anticipated

Primary completion date

Jul 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Chronic thromboembolic disease

Patients with chronic thromboembolic disease/pulmonary hypertension

Interventions

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 measure

  • 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 ]

Central Contacts and Locations

Central contacts

Miles Conrad, MD

(415) 353-1300miles.conrad@ucsf.edu

Xiao Wu, MD

628-286-7340xiao.wu@ucsf.edu

Locations

University of California San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Miles Conrad, MD

415-353-1300miles.conrad@ucsf.edu

Xiao Wu, MD

628-286-7340xiao.wu@ucsf.edu

Principal Investigator:

Miles Conrad, MD

More Information

Sponsor

University of California, San Francisco

Last update posted

Jul 14, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-07-14.