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

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Dr Sudarshan Rajagopal
Study ID
NCT05140525
Phase
PHASE3
Status
Recruiting
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Conditions

  • CTEPH

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Macitentan Tablets — DRUG
    10 mg oral once daily
  • Riociguat — DRUG
    1 mg to 2.5mg oral three times daily
  • balloon pulmonary angioplasty — DEVICE
    on hemodynamics and RV function (including advanced assessments of RV-PA coupling

Study Details

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.

Key Dates

Start date
Jan 27, 2025
Status verified
Jun 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
15 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: participants with inoperable CTEPH
    subject with inoperable Chronic thromboembolic Pulmonary Hypertension
  • Active Comparator: post PTE residual CTEPH
    Subject with post pulmonary endarterectomy (PTE) residual Chronic Thromboembolic Pulmonary Hypertension

Primary Outcome Measure

Change in end-systolic elastance (Ees) divided by arterial elastance (Ea) (Ees/Ea) at three time points: Baseline, Timepoint 1 and Timepoint 2. [ Time Frame: Baseline (before starting all treatments); Timepoint 1 (after starting medical therapy; up to 6 months after baseline); Timepoint 2 (after balloon pulmonary angioplasty (BPA); up to 12 months after baseline) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University Medical CenterDurhamNorth Carolina27710
David Ptashnik, MS
[email protected]
9196682642
Sudarshan Rajagopal, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Durham, NC

By research site
Duke University Medical Center· Durham, NC

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