Diagnostic delay in pulmonary hypertension: determinants and impact on disease severity at initial presentation
NCT ID NCT07810881
First seen Sep 09, 2026 · Last updated Sep 09, 2026
Summary
Pulmonary hypertension (PH) is a progressive cardiopulmonary condition that may remain undiagnosed for a prolonged period because its initial symptoms are often nonspecific. This study aims to assess the relationship between diagnostic delay and disease severity at the time of initial presentation among adult patients with pulmonary hypertension at Assiut University Heart Hospital. The study will use an observational cross-sectional analytical design with retrospective review of available medical records and prospective data collection. Eligible patients will be consecutively recruited. Data will include demographic and clinical characteristics, duration of symptoms before diagnosis, previous medical consultations and diagnoses, WHO functional class, six-minute walk distance, echocardiographic findings, laboratory investigations, and available right heart catheterization data. The primary outcome is advanced disease at presentation, defined as WHO functional class III-IV. The study will also assess clinical, echocardiographic, functional, and hemodynamic markers of disease severity and potential factors associated with diagnostic delay.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Adult patients (aged 18 years or older) with pulmonary hypertension who present to the Pulmonary Hypertension Unit/Cardiology Department at Assiut University Heart Hospital during the study period. Participants will include patients with pulmonary hypertension confirmed by right heart catheterization when available, or patients with high echocardiographic probability or a clinician diagnosis of pulmonary hypertension when right heart catheterization is not available.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 1\. Age 18 years or older 2\. Patients with pre-capillary pulmonary hypertension, Group 1 PAH, Group 3 PH associated with lung disease/hypoxia, Group 4 chronic thromboembolic pulmonary hypertension (CTEPH) or other pulmonary artery obstructions, and Group 5 PH with unclear or multifactorial mechanisms. 3\. Diagnosis of pulmonary hypertension based on RHC when available, or high echocardiographic probability/clinician diagnosis of PH when RHC is not available. 4\. Availability of baseline clinical assessment at or near the time of diagnosis or first PH-unit presentation. 5\. Ability to provide an approximate date or month/year of first PH-related symptom. 6\. Willingness to participate and provide informed consent. Exclusion Criteria: * 1\. Inability to provide reliable information about symptom onset and no alternative documentation in the medical record. 2\. Incomplete baseline data preventing classification of disease severity. 3. Post-capillary pulmonary hypertension due to left heart disease (Group 2 PH). 4\. Acute pulmonary embolism as the sole acute cause of transient pulmonary pressure elevation at presentation. 5\. Severe acute illness, cognitive impairment, or communication barrier preventing questionnaire completion. 6\. Refusal to participate. 7. Optional exclusion according to committee preference: patients with isolated post-capillary PH due to left heart disease may be excluded if the aim is to focus on PAH/pre-capillary PH.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
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How to take part
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The official record
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