RecruitingNot Applicable

Chronic Thromboembolic Disease Registry

United States100 participantsStarted 2023-08-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Total number of patients who survive

Timeframe: Through study completion, an average of 5 years

Changes in exercise tolerance

Timeframe: Baseline to end of the study, an average of 5 years

Changes in supplemental oxygen use severity

Timeframe: Baseline to end of the study, an average of 5 years

Changes in New York Heart Association (NYHA) functional class

Timeframe: Baseline to end of the study, an average of 5 years

European Quality of Life Five Dimension (EQ-5D) - Scale Score

Timeframe: Baseline to end of the study, an average of 5 years

Changes in patients' emPHasis-10 scores

Timeframe: Baseline to end of the study, an average of 5 years

Number of patients undergoing lung transplantation

Timeframe: Baseline to end of the study, an average of 5 years

Trial details

NCT IDNCT05843500

SponsorUniversity of California, San Francisco

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-07-01

Contact for this trial

Miles Conrad, MD

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

View on ClinicalTrials.gov More Chronic Thromboembolic Pulmonary Hypertension trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

What they're measuring

Total number of patients who survive

Timeframe: Through study completion, an average of 5 years

Changes in exercise tolerance

Timeframe: Baseline to end of the study, an average of 5 years

Changes in supplemental oxygen use severity

Timeframe: Baseline to end of the study, an average of 5 years

Changes in New York Heart Association (NYHA) functional class

Timeframe: Baseline to end of the study, an average of 5 years

European Quality of Life Five Dimension (EQ-5D) - Scale Score

Timeframe: Baseline to end of the study, an average of 5 years

Changes in patients' emPHasis-10 scores

Timeframe: Baseline to end of the study, an average of 5 years

Number of patients undergoing lung transplantation

Timeframe: Baseline to end of the study, an average of 5 years