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

ConditionCTEPH
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorDr Sudarshan Rajagopal

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years' old

Diagnosis of CTEPH

Not a candidate for PTE

Candidate for BPA based on suitable anatomy and disease burden

Disqualifiers

Moderate to severe heart disease (LVEF < 45% or severe LV Hypertrophy)

Sarcoidosis

Active cancer

Sickle cell anemia

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

15 Participants
are divided into 2 treatment groups
Group A: participants with inoperable CTEPHActive comparator 3 interventions
Group B: post PTE residual CTEPHActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

Change in end-systolic elastance (Ees) divided by arterial elastance (Ea) (Ees/Ea) at three time points: Baseline, Timepoint 1 and Timepoint 2.

Ees is a measure of right ventricular (RV) - pulmonary arterial (PA) coupling, with a normal value of Ees/Ea \> 0.8 (dimensionless - no units). For subjects with Ees/Ea \> 0.8 at the start of the study, we will evaluate the absolute change in Ees/Ea between timepoints. For those with an Ees/Ea \< 0.8, we will also determine whether participants have an improvement to \> 0.8.

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)

Secondary outcomes

1

Change in six-minute walk distance (6MWD) in meters.

6MWD will be determined at baseline, timepoint 1 and timepoint 2. Absolute change between these timepoints will be determined.

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)
2

Change in N-terminal pro-brain natriuretic peptide (NT-proBNP) in picogram/milliliters.

NT-proBNP will be determined at baseline, timepoint 1 and timepoint 2. Absolute change between these timepoints will be determined.

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)
3

Change in Cardiac index as measured by liters per minute per meters squared at right heart catheterization.

Right heart catheterization will be performed at baseline, timepoint 1 and timepoint 2 and parameters determined. Absolute change between these timepoints will be determined.

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)
4

Change in pulmonary vascular resistance as measured by Wood units at right heart catheterization.

Right heart catheterization will be performed at baseline, timepoint 1 and timepoint 2 and parameters determined. Absolute change between these timepoints will be determined.

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)

Other outcomes

Sponsors and contacts

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

Dr Sudarshan Rajagopal

Lead sponsor

Duke University

Sponsor institution

Janssen Pharmaceutica N.V., Belgium

Collaborator

Source ClinicalTrials.gov
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