NCT07810881Not yet recruiting
Diagnostic Delay in PHTN
Diagnostic Delay in Pulmonary Hypertension: Determinants and Impact on Disease Severity at Initial Presentation
Source: ClinicalTrials.gov · Last updated 9 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 80 (estimated)
- First submitted
- 4 Sept 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 1 Nov 2027
- Lead sponsor
- Assiut University
- NCT number
- NCT07810881
What you commit to
- Study type: Observational
- Planned participants: 80
- From 1 Sept 2026 to the primary completion date, 1 Nov 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.