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NCT07810881
Diagnostic Delay in PHTN
Conditions: Delayed Diagnosis Pulmonary Hypertension
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 80
Sponsor: Assiut University
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07810881). StuddyBuddy aggregates publicly available trial information.