Arterial Wave Energy Flux and Multidimensional Recovery in Patients With Chronic Thromboembolic Pulmonary Hypertension Undergoing Balloon Pulmonary Angioplasty
WE FIX BPA
1 other identifier
observational
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2026
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 10, 2026
CompletedFirst Submitted
Initial submission to the registry
March 28, 2026
CompletedFirst Posted
Study publicly available on registry
April 13, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2028
April 13, 2026
April 1, 2026
2.1 years
March 28, 2026
April 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
6 minute walking distance
6 minute walking distance as part of standard 6MWT
baseline, before each BPA sessions, 1 month after the last BPA session
NT-proBNP
NT-proBNP level in blood
baseline, before each BPA sessions, 1 month after the last BPA session
EuroQol 5-Dimension 5-Level questionnaire scores
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.
baseline, before each BPA sessions, 1 month after the last BPA session
TAPSE
Tricuspid Annular Plane Systolic Excursion (TAPSE) is an indicator of RV systolic function
baseline, before each BPA session, 1 month after the last BPA session
WIA
WIA quantifies arterial wave energy flux and identifies forward and backward compression waves (FCW, BCW) and expansion waves (FEW) within the cardiac cycle.
baseline, periprocedural (immediately at the beginning and at the end of each BPA session)
REPA
REPA decomposes the pressure waveform into reservoir pressure (Pr), representing arterial storage, and excess pressure (Pxs), representing the dynamic wave component.
baseline, periprocedural (immediately at the beginning and at the end of each BPA session)
Study Arms (1)
Patients with CTEPH
Interventions
Balloon Pulmonary Angioplasty as per procedural standards
Eligibility Criteria
The study will include consecutive patients with a confirmed diagnosis of CTEPH according to current guidelines who are clinical candidates for balloon pulmonary angioplasty (BPA).
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Istanbul Mehmet Akif Ersoy Educational and Training Hospital
Istanbul, 34303, Turkey (Türkiye)
Related Publications (1)
Tas A, Alan Y, Ozcan A, Parker KH, van de Hoef T, Sezer M, Piek JJ. Ventricular-Coronary Interaction Delay is Associated With Discordance Between Fractional Flow Reserve and Coronary Flow Reserve in Intermediate Coronary Stenoses. Am J Cardiol. 2025 Aug 1;248:80-88. doi: 10.1016/j.amjcard.2025.04.003. Epub 2025 Apr 11.
PMID: 40222466BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
March 28, 2026
First Posted
April 13, 2026
Study Start
March 10, 2026
Primary Completion (Estimated)
April 1, 2028
Study Completion (Estimated)
May 1, 2028
Last Updated
April 13, 2026
Record last verified: 2026-04