Arterial Wave Energy Flux and Multidimensional Recovery in Patients With Chronic Thromboembolic Pulmonary Hypertension Undergoing Balloon Pulmonary Angioplasty
Recruiting · NCT07522203 · Observational (researchers observe without assigning treatment) · Lead sponsor: Istanbul Mehmet Akif Ersoy Educational and Training Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The goal of this observational study is to learn if advanced heart pressure wave analysis (called WIA and REPA) can help track and predict clinical improvement in adults (aged 18-85) with Chronic Thromboembolic Pulmonary Hypertension (CTEPH) who are undergoing Balloon Pulmonary Angioplasty (BPA). The main questions it aims to answer are: Do changes in these advanced heart pressure wave patterns relate to improvements in a patient's walking distance, heart function, and overall quality of life after BPA treatment? Are these new measurements more effective than standard heart pressure tests at showing how much a patient has truly improved? Participants will: Undergo standard Balloon Pulmonary Angioplasty (BPA) sessions as part of their regular medical care for CTEPH. Have their heart pressure waves recorded through a catheter during the routine BPA procedure (this does not require any extra surgical steps). Complete walking tests (6-minute walk test), blood tests, and heart ultrasounds (echocardiography) before starting the treatment and after it is completed. Fill out short surveys regarding their daily physical activity and quality of life.
Who can take part
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 is running
1 location listed.
- Istanbul Mehmet Akif Ersoy Educational and Training Hospital - Istanbul, Turkey (Türkiye)