NCT05140525 · Dr Sudarshan Rajagopal
Effects of Combination Medical Therapy Followed by BPA on Right Ventricular-PA Coupling and Hemodynamics in CTEPH
(EPIPHANY)
What this study is about
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.
View original scientific 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.
Interventions
DRUG
Macitentan Tablets
10 mg oral once daily
DRUG
Riociguat
1 mg to 2.5mg oral three times daily
DEVICE
balloon pulmonary angioplasty
on hemodynamics and RV function (including advanced assessments of RV-PA coupling
Primary outcome measures
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)
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
- Age ≥ 18 years' old
- Diagnosis of CTEPH
- Not a candidate for PTE
- Candidate for BPA based on suitable anatomy and disease burden
- 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.
- 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:
- Moderate to severe heart disease (LVEF \< 45% or severe LV Hypertrophy)
- Sarcoidosis
- Active cancer
- Sickle cell anemia
- Liver disease (Childs-Pugh class C)
- Pregnant, planning pregnancy or lactating
- Conditions that will prohibit MRI scanning (metal in eye, claustrophobia, inability to lie supine)
- Contraindication to riociguat or macitentan
- 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
Where
- Durham, North Carolina
Collaborators
Janssen Pharmaceutica N.V., Belgium
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 21, 2025 · Source of record for eligibility and locations