Arterial wave energy and recovery after balloon pulmonary angioplasty for CTEPH

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.