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

ConditionsCTEPHPulmonary Hypertension (PH)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorIstanbul Mehmet Akif Ersoy Educational and Training Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-85 years.

Disqualifiers

Predominant diagnosis of PH other than CTEPH or concomitant severe parenchymal lung disease.

Trial population

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).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Balloon Pulmonary Angioplasty

    Procedure/Surgery

    Balloon Pulmonary Angioplasty as per procedural standards

Treatment groups

70 Participants
are divided into 1 treatment group
Group A: Patients with CTEPH1 intervention

Trial outcomes

Primary outcomes

1

6 minute walking distance

6 minute walking distance as part of standard 6MWT

Time frame
baseline, before each BPA sessions, 1 month after the last BPA session
2

NT-proBNP

NT-proBNP level in blood

Time frame
baseline, before each BPA sessions, 1 month after the last BPA session
3

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.

Time frame
baseline, before each BPA sessions, 1 month after the last BPA session
4

TAPSE

Tricuspid Annular Plane Systolic Excursion (TAPSE) is an indicator of RV systolic function

Time frame
baseline, before each BPA session, 1 month after the last BPA session

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Istanbul Mehmet Akif Ersoy Educational and Training Hospital

Lead sponsor

Source ClinicalTrials.gov
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