Actively Recruiting

Age: 18Years - 85Years
All Genders
NCT07522203

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

111 weeks

Total Duration

On this page

AI-Summary

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.

CONDITIONS

Official 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

Eligible

You may qualify if you...

  • Age 18 to 85 years
  • Confirmed diagnosis of Chronic Thromboembolic Pulmonary Hypertension (CTEPH) and eligible for Balloon Pulmonary Angioplasty (BPA)
  • Hemodynamics consistent with pre-capillary pulmonary hypertension measured by right heart catheterization
  • Technically inoperable CTEPH or persistent/recurrent pulmonary hypertension after pulmonary endarterectomy (PEA)
  • Ability to provide written informed consent
Not Eligible

You will not qualify if you...

  • Diagnosis of pulmonary hypertension other than CTEPH or severe parenchymal lung disease
  • Active infection, uncontrolled systemic disease, active cancer, or life expectancy less than 12 months
  • Pregnant or breastfeeding
  • Advanced kidney failure (eGFR less than 30 mL/min/1.73 m²) or contraindication to contrast media
  • Poor echocardiographic image quality preventing reliable analysis
  • Pressure tracing artifacts or uncontrolled arrhythmias such as rapid atrial fibrillation
  • Hemodynamically unstable or decompensated patients
  • Any other condition considered unsuitable by the investigator

AI-Screening

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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

CONTACT

A

Ahmet Tas, MD PhD

CONTACT

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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