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Endothelin Receptor Antagonist

Combination Therapy + BPA for Thromboembolic Pulmonary Hypertension (EPIPHANY Trial)

Phase 3
Waitlist Available
Led By Sudarshan Rajagopal, MD, PhD
Research Sponsored by Dr Sudarshan Rajagopal
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 years' old
Diagnosis of CTEPH
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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)
Awards & highlights

EPIPHANY Trial Summary

This trial is testing a new combination therapy for inoperable or residual Chronic Thromboembolic Pulmonary Hypertension (CTEPH). The therapy consists of two drugs, Riociguat and Macitentan, and balloon pulmonary angioplasty (BPA). The goal is to see if this new therapy can improve RV function and hemodynamics.

Who is the study for?
This trial is for adults over 18 with CTEPH who can't have surgery, haven't started treatment, and are eligible for balloon pulmonary angioplasty (BPA). They must be able to consent and follow the study plan. People with contraindications to the drugs being tested, severe liver disease, heart conditions, active cancer or sickle cell anemia cannot participate.Check my eligibility
What is being tested?
The study tests how a combination of Macitentan tablets and Riociguat followed by BPA affects blood flow dynamics and right heart function in patients with CTEPH that's not suitable for surgery. It aims to see if this approach improves the coupling between the right ventricle and pulmonary artery.See study design
What are the potential side effects?
Possible side effects include issues like low blood pressure, headache, dizziness from Riociguat; liver problems or anemia from Macitentan; bleeding or injury related to BPA procedure. Each patient may experience side effects differently.

EPIPHANY Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have been diagnosed with chronic thromboembolic pulmonary hypertension.
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I have not started treatment for CTEPH/PAH but plan to, including BPA.

EPIPHANY Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
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.
Secondary outcome measures
Change in Cardiac index as measured by liters per minute per meters squared at right heart catheterization.
Change in N-terminal pro-brain natriuretic peptide (NT-proBNP) in picogram/milliliters.
Change in pulmonary vascular resistance as measured by Wood units at right heart catheterization.
+2 more

EPIPHANY Trial Design

2Treatment groups
Active Control
Group I: participants with inoperable CTEPHActive Control3 Interventions
subject with inoperable Chronic thromboembolic Pulmonary Hypertension
Group II: post PTE residual CTEPHActive Control3 Interventions
Subject with post pulmonary endarterectomy (PTE) residual Chronic Thromboembolic Pulmonary Hypertension

Find a Location

Who is running the clinical trial?

Dr Sudarshan RajagopalLead Sponsor
ActelionIndustry Sponsor
191 Previous Clinical Trials
35,673 Total Patients Enrolled
Sudarshan Rajagopal, MD, PhDPrincipal InvestigatorDuke Health System
3 Previous Clinical Trials
101 Total Patients Enrolled

Media Library

Macitentan Tablets (Endothelin Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05140525 — Phase 3
Thromboembolic Pulmonary Hypertension Research Study Groups: participants with inoperable CTEPH, post PTE residual CTEPH
Thromboembolic Pulmonary Hypertension Clinical Trial 2023: Macitentan Tablets Highlights & Side Effects. Trial Name: NCT05140525 — Phase 3
Macitentan Tablets (Endothelin Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05140525 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has this clinical trial been conducted before?

"As of right now, there are 16 different ongoing trials for post PTE residual CTEPH in 131 cities and 47 countries. The first study was completed back in 2008 and only involved 22 patients. However, since then, 57 more studies have been conducted."

Answered by AI

How many people are being enrolled in this clinical trial?

"Unfortunately, this particular study is not enrolling patients at the moment. The listing was originally created on January 1st 2023 but was edited last on October 5th, 2022. However, there are other options; 19 studies for people with chronic thromboembolic pulmonary hypertension (cteph) and 16 studies for post PTE residual CTEPH are still admitting patients."

Answered by AI

Are there serious dangers associated with post PTE residual CTEPH?

"Given that this is a Phase 3 trial with some efficacy data as well as multiple reports on safety, the Power team rated post PTE residual CTEPH's safety at a level 3."

Answered by AI

Have other studies been conducted that focus on post PTE residual CTEPH?

"At the moment, there are 16 clinical trials researching post PTE residual CTEPH. A third of those active studies are in their final Phase 3 stage. The majority of research for this treatment is conducted in Krakow and Lazio; however, there are 938 total research sites worldwide."

Answered by AI

Are we currently enrolling patients for this experiment?

"No, this particular clinical study is not admitting any more patients at the moment. This trial was first posted on 1/1/2023 and edited for the last time on 10/5/2022. If you're looking for other cteph trials, there are 19 studies still recruiting and 16 post PTE residual CTEPH studies that are actively seeking participants.."

Answered by AI
~10 spots leftby Jul 2024