Arterial Wave Energy Flux and Multidimensional Recovery in Patients With Chronic Thromboembolic P… (NCT07522203) | Clinical Trial Compass
RecruitingNot Applicable
Arterial Wave Energy Flux and Multidimensional Recovery in Patients With Chronic Thromboembolic Pulmonary Hypertension Undergoing Balloon Pulmonary Angioplasty
Turkey (Türkiye)70 participantsStarted 2026-03-10
Plain-language 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.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
6 minute walking distance
Timeframe: baseline, before each BPA sessions, 1 month after the last BPA session
2
NT-proBNP
Timeframe: baseline, before each BPA sessions, 1 month after the last BPA session
3
EuroQol 5-Dimension 5-Level questionnaire scores
Timeframe: baseline, before each BPA sessions, 1 month after the last BPA session
4
TAPSE
Timeframe: baseline, before each BPA session, 1 month after the last BPA session
5
WIA
Timeframe: baseline, periprocedural (immediately at the beginning and at the end of each BPA session)
6
REPA
Timeframe: baseline, periprocedural (immediately at the beginning and at the end of each BPA session)
Trial details
NCT IDNCT07522203
SponsorIstanbul Mehmet Akif Ersoy Educational and Training Hospital