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NCT05140525 | NOT YET RECRUITING | CTEPH

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

Dr Sudarshan Rajagopal

Information provided by (Responsible Party):

Dr Sudarshan Rajagopal

Brief Summary:

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.

Condition or disease

staph

Intervention/treatment

Macitentan Tablets

Riociguat

balloon pulmonary angioplasty

Phase

PHASE3

Detailed Description:

Recent presented but unpublished results from trials of BPA vs riociguat for inoperable CTEPH (NCT02634203) have demonstrated that BPA provides a more significant hemodynamic benefit than medical therapy. The investigators hypothesize that participants who are treated with upfront combination medical therapy followed by BPA will have significant improvements in their hemodynamics and RV-PA coupling that can be monitored over time.

Study Type : INTERVENTIONAL
Estimated Enrollment : 15 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Effects of Combination Medical Therapy Followed by Balloon Pulmonary Angioplasty on Right Ventricular-PA Coupling and Hemodynamics in Chronic Thromboembolic Pulmonary Hypertension
Actual Study Start Date : 2025-01-30
Estimated Primary Completion Date : 2026-12-31
Estimated Study Completion Date : 2026-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial
    • 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).
    Exclusion Criteria
    • * 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
Effects of Combination Medical Therapy Followed by BPA on Right Ventricular-PA Coupling and Hemodynamics in CTEPH

Location Details

NCT05140525

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Locations

Not yet recruiting

United States, North Carolina

Duke University Medical Center

Durham, North Carolina, United States, 27710