Ventricular-Coronary Interaction Delay is Associated With Discordance Between Fractional Flow Reserve and Coronary Flow Reserve in Intermediate Coronary Stenoses.
Ahmet Tas, Yaren Alan, Alp Ozcan...
https://pubmed.ncbi.nlm.nih.gov/40222466Actively Recruiting
Age: 18Years - 85Years
All Genders
ID07522203
Arterial Wave Energy Flux and Multidimensional Recovery in Patients With Chronic Thromboembolic Pulmonary Hypertension Undergoing Balloon Pulmonary Angioplasty
Led by Istanbul Mehmet Akif Ersoy Educational and Training Hospital · Updated on 2026-04-13
70
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to understand if advanced heart pressure wave analysis methods called WIA and REPA can help track and predict health improvements in adults aged 18 to 85 with Chronic Thromboembolic Pulmonary Hypertension (CTEPH) undergoing Balloon Pulmonary Angioplasty (BPA). It focuses on whether changes in these wave patterns relate to better walking ability, heart function, and quality of life, and if these new measures are better than standard heart pressure tests. Participants will receive standard BPA treatment as part of their usual care. During each BPA session, heart pressure waveforms are recorded using a catheter without extra invasive steps. Clinical assessments including 6-minute walking tests, blood tests, and heart ultrasounds are done before treatment, during BPA sessions, and about one month after the last BPA session. Participants also complete surveys about their physical activity and quality of life. Throughout the study, researchers will collect data on heart function, walking distance, biomarkers like NT-proBNP, and quality of life scores to evaluate clinical improvement. Advanced wave analysis is done during BPA sessions to measure wave energy and pressure components. Safety events related to BPA are monitored, and the study lasts through treatment and a follow-up period one month after the final BPA session.
CONDITIONS
Brief Title
Arterial Wave Energy Flux and Multidimensional Recovery in Patients With Chronic Thromboembolic Pulmonary Hypertension Undergoing Balloon Pulmonary Angioplasty
Who Can Participate
Age: 18Years - 85Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 to 85 years
- Confirmed diagnosis of Chronic Thromboembolic Pulmonary Hypertension (CTEPH) eligible for Balloon Pulmonary Angioplasty (BPA)
- Hemodynamics consistent with pre-capillary pulmonary hypertension confirmed by right heart catheterization
- Patients who are technically inoperable or have persistent/recurrent pulmonary hypertension after pulmonary endarterectomy
- Willingness and ability to provide written informed consent
You will not qualify if you...
- Predominant diagnosis of pulmonary hypertension other than CTEPH or severe lung disease
- Active infection, uncontrolled systemic disease, active cancer, or life expectancy less than 12 months
- Pregnancy or breastfeeding
- Advanced kidney failure or contraindications to contrast media
- Poor quality echocardiographic images preventing reliable analysis
- Significant artifacts in pressure recordings or uncontrolled arrhythmias
- Hemodynamically unstable or decompensated patients
- Any other condition considered unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - Duration of BPA treatment sessions (variable, multiple sessions as per routine clinical care)
Participants undergo baseline clinical assessments including walking distance, blood tests, heart function, and quality of life measures before starting Balloon Pulmonary Angioplasty (BPA). Pressure waveforms are recorded during routine BPA procedures without additional invasive interventions.
Visits before and after each BPA session
Long-term Monitoring
Duration - 1 month after last BPA session
Participants have a final follow-up assessment approximately 1 month after the last BPA session to evaluate clinical and functional recovery.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Istanbul Mehmet Akif Ersoy Educational and Training Hospital
Istanbul, Turkey (Türkiye), 34303
Actively Recruiting
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Research Team
U
Umit Bulut, MD
A
Ahmet Tas, MD PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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