Recruiting

Arterial Wave Energy Flux and Multidimensional Recovery in Patients With Chronic Thromboembolic Pulmonary Hypertension Undergoing Balloon Pulmonary Angioplasty

ClinicalTrials.gov IDNCT07522203

PhaseNot Applicable

Enrollment70

SponsorIstanbul Mehmet Akif Ersoy Educational and Training Hospital

Age18 Years – 85 Years

SexALL

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Conditions studied

CTEPH, Pulmonary Hypertension (PH)

About this study

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.

Interventions

Procedure: Balloon Pulmonary Angioplasty — Balloon Pulmonary Angioplasty as per procedural standards

Primary outcomes

6 minute walking distance (baseline, before each BPA sessions, 1 month after the last BPA session)
NT-proBNP (baseline, before each BPA sessions, 1 month after the last BPA session)
EuroQol 5-Dimension 5-Level questionnaire scores (baseline, before each BPA sessions, 1 month after the last BPA session)
TAPSE (baseline, before each BPA session, 1 month after the last BPA session)
WIA (baseline, periprocedural (immediately at the beginning and at the end of each BPA session))
REPA (baseline, periprocedural (immediately at the beginning and at the end of each BPA session))

Eligibility information

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.

Study locations

Istanbul Mehmet Akif Ersoy Educational and Training Hospital, Istanbul, 34303 Turkey (Türkiye)

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-05.