Effects of Combination Medical Therapy Followed by BPA on Right Ventricular-PA Coupling and Hemodynamics in CTEPH

Description

The main goal of this study is to determine the effects of combination medical therapy (Riociguat and Macitentan) and balloon pulmonary angioplasty (BPA) on hemodynamics and right ventricular (RV) function (including advanced assessments of RV-pulmonary artery (PA) coupling from invasive hemodynamics) in participants with inoperable or post-PTE residual CTEPH.

Conditions

CTEPH

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Study Overview

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Study Details

Study overview

The main goal of this study is to determine the effects of combination medical therapy (Riociguat and Macitentan) and balloon pulmonary angioplasty (BPA) on hemodynamics and right ventricular (RV) function (including advanced assessments of RV-pulmonary artery (PA) coupling from invasive hemodynamics) in participants with inoperable or post-PTE residual CTEPH.

Effects of Combination Medical Therapy Followed by Balloon Pulmonary Angioplasty on Right Ventricular-PA Coupling and Hemodynamics in Chronic Thromboembolic Pulmonary Hypertension

Effects of Combination Medical Therapy Followed by BPA on Right Ventricular-PA Coupling and Hemodynamics in CTEPH

Condition
CTEPH
Intervention / Treatment

-

Contacts and Locations

Durham

Duke University Medical Center, Durham, North Carolina, United States, 27710

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Age ≥ 18 years' old
  • 2. Diagnosis of CTEPH
  • 3. Not a candidate for PTE
  • 4. Candidate for BPA based on suitable anatomy and disease burden
  • 5. Treatment-naïve (no CTEPH or pulmonary arterial hypertension (PAH)-specific medical therapies) with plans for initiation of CTEPH/PAH-specific medical therapy and treatment with BPA.
  • 6. Willing and able to give informed consent and adhere to visit/protocol schedules (Consent must be given before any study procedures are performed).
  • * Subjects presenting with any of the following will not be included in the trials:
  • 1. Moderate to severe heart disease (LVEF \< 45% or severe LV Hypertrophy)
  • 2. Sarcoidosis
  • 3. Active cancer
  • 4. Sickle cell anemia
  • 5. Liver disease (Childs-Pugh class C)
  • 6. Prisoners
  • 7. Pregnant, planning pregnancy or lactating
  • 8. Conditions that will prohibit MRI scanning (metal in eye, claustrophobia, inability to lie supine)
  • 9. Contraindication to riociguat or macitentan
  • 10. Medical or psychological conditions which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Dr Sudarshan Rajagopal,

Sudarshan Rajagopal, MD, PhD, PRINCIPAL_INVESTIGATOR, Duke Health System

Study Record Dates

2026-12-31