Arterial wave energy and recovery after balloon pulmonary angioplasty for CTEPH
Arterial Wave Energy Flux and Multidimensional Recovery in Patients With Chronic Thromboembolic Pulmonary Hypertension Undergoing Balloon Pulmonary Angioplasty
This tests whether advanced pulmonary artery pressure wave analysis can track and predict recovery in adults (18–85) with chronic thromboembolic pulmonary hypertension treated with balloon pulmonary angioplasty.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Istanbul Mehmet Akif Ersoy Educational and Training Hospital Government |
| Locations | 1 site (Istanbul) |
| Trial ID | NCT07522203 on ClinicalTrials.gov |
What this trial studies
This is a prospective observational protocol that records pulmonary artery pressure waveforms during routine balloon pulmonary angioplasty and applies wave intensity analysis (WIA) and reservoir-excess pressure analysis (REPA). Patients receive standard-of-care BPA and undergo serial assessments including 6-minute walk distance, NT-proBNP, RV strain by echocardiography, and quality-of-life questionnaires. The waveform-derived pulsatile metrics will be compared to conventional steady-flow hemodynamics (mPAP, PVR) to see which metrics best track multidimensional clinical improvement. No extra invasive procedures are required beyond the catheter recordings obtained during planned BPA sessions.
Who should consider this trial
Good fit: Adults aged 18–85 with confirmed CTEPH judged eligible for BPA (technically inoperable or persistent/recurrent PH after PEA) and hemodynamics consistent with pre-capillary PH who can give informed consent are ideal candidates.
Not a fit: Patients with predominant non-CTEPH pulmonary hypertension, severe parenchymal lung disease, uncontrolled comorbidities, poor-quality tracings or arrhythmias that prevent reliable waveform analysis, or contraindications to BPA or contrast are unlikely to benefit from these measurements.
Why it matters
Potential benefit: If successful, these waveform measures could give clinicians a more sensitive way to monitor and predict functional and right-heart recovery after BPA, allowing better tailored follow-up and treatment decisions.
How similar studies have performed: Wave-based hemodynamic methods have shown promise in systemic arterial research and small pulmonary studies, but applying WIA and REPA to predict BPA outcomes in CTEPH is largely novel with limited prior clinical data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Age 18-85 years.
Confirmed diagnosis of CTEPH by a multidisciplinary CTEPH team and deemed eligible for BPA.
Hemodynamics compatible with pre-capillary PH according to current guidelines, as assessed by RHC (Right Heart Catheterization).
Technically inoperable CTEPH or persistent/recurrent PH following PEA (Pulmonary Endarterectomy).
Written informed consent.
Exclusion Criteria:
* Predominant diagnosis of PH other than CTEPH or concomitant severe parenchymal lung disease.
Active infection, uncontrolled systemic disease, active malignancy, or life expectancy \< 12 months.
Pregnant or lactating patients.
Advanced renal failure (e.g., eGFR \< 30 \\text{ mL/min/1.73 m\^2}) or contraindications to contrast media (per institutional routine).
Inadequate image quality precluding reliable echocardiographic analysis.
Pressure tracings with significant artifacts hindering analysis or uncontrolled arrhythmia (e.g., atrial fibrillation with rapid ventricular response).
Decompensated or hemodynamically unstable patients.
Any other condition deemed clinically unsuitable by the investigator.
Where this trial is running
Istanbul
- Istanbul Mehmet Akif Ersoy Educational and Training Hospital — Istanbul, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Umit Bulut, MD
- Email: umit.bulut@saglik.gov.tr
- Phone: +90(212) 692 20 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.