Arterial Wave Energy Flux and Multidimensional Recovery in Patients With Chronic Thromboembolic Pulmonary Hypertension Undergoing Balloon Pulmonary Angioplasty
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- 6 minute walking distance
Study Overview
Brief Summary
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.
Detailed Description
This prospective observational study aims to investigate the relationship between pulsatile wave-based hemodynamic metrics (WIA and REPA) derived from pulmonary artery pressure waveforms and multidimensional clinical improvement (RV strain, 6MWT, NT-proBNP, and quality of life) in CTEPH patients undergoing BPA. The study will be conducted within standard clinical care without additional invasive interventions.
2. BACKGROUND AND RATIONALE 2.1 Definition and Importance CTEPH (Group 4 PH) results from organized thromboembolic material in the pulmonary arteries causing obstruction and microvascular disease. Diagnosis requires imaging (V/Q, CTPA) and confirmation via RHC.
2.2 Role of BPA BPA is indicated for patients who are technically inoperable or have persistent PH after PEA. Current guidelines support BPA for improving hemodynamics and functional capacity.
2.3 Limitations of Standard Parameters Traditional metrics (mPAP, PVR) represent steady-flow relationships. RV afterload is also dictated by pulsatile load (compliance and reflections). In CTEPH, proximal obstructions and distal disease timing significantly influence RV remodeling and clinical response.
2.4 Modern Hemodynamic Methods: WIA and REPA WIA identifies forward and backward compression waves (FCW, BCW) and expansion waves (FEW) within the cardiac cycle. REPA decomposes the pressure waveform into reservoir pressure (Pr), representing arterial storage, and excess pressure (Pxs), representing the dynamic wave component.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Patients with CTEPH
Intervention: Balloon Pulmonary Angioplasty (Procedure)
Outcomes
Primary Outcomes
6 minute walking distance
Time Frame: baseline, before each BPA sessions, 1 month after the last BPA session
6 minute walking distance as part of standard 6MWT
NT-proBNP
Time Frame: baseline, before each BPA sessions, 1 month after the last BPA session
NT-proBNP level in blood
EuroQol 5-Dimension 5-Level questionnaire scores
Time Frame: baseline, before each BPA sessions, 1 month after the last BPA session
EQ-5D-5L (The 5-level EQ-5D version (EQ-5D-5L)) is a standardised measure of health-related quality of life developed by the EuroQol Group. Higher scores indicate better outcome. Test subsections have ratings up to 5 in 5 dimensions.
TAPSE
Time Frame: baseline, before each BPA session, 1 month after the last BPA session
Tricuspid Annular Plane Systolic Excursion (TAPSE) is an indicator of RV systolic function
WIA
Time Frame: baseline, periprocedural (immediately at the beginning and at the end of each BPA session)
WIA quantifies arterial wave energy flux and identifies forward and backward compression waves (FCW, BCW) and expansion waves (FEW) within the cardiac cycle.
REPA
Time Frame: baseline, periprocedural (immediately at the beginning and at the end of each BPA session)
REPA decomposes the pressure waveform into reservoir pressure (Pr), representing arterial storage, and excess pressure (Pxs), representing the dynamic wave component.
Secondary Outcomes
No secondary outcomes reported
Investigators
Umit Bulut
MD
Istanbul Mehmet Akif Ersoy Educational and Training Hospital