Actively Recruiting

Phase 3
Age: 18Years +
All Genders
ID05140525

Effects of Combination Medical Therapy Followed by Balloon Pulmonary Angioplasty on Right Ventricular-PA Coupling and Hemodynamics in Chronic Thromboembolic Pulmonary Hypertension

Led by Dr Sudarshan Rajagopal · Updated on 2025-10-21

15

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

D

Dr Sudarshan Rajagopal

Lead Sponsor

J

Janssen Pharmaceutica N.V., Belgium

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying the effects of combining two medications, Riociguat and Macitentan, followed by balloon pulmonary angioplasty (BPA) on heart function and blood flow in people with chronic thromboembolic pulmonary hypertension (CTEPH) who cannot have surgery or have remaining disease after surgery. The study focuses on how these treatments improve the heart's right ventricle and its connection to the lungs' blood vessels. This is a Phase 3 clinical trial led by Dr. Sudarshan Rajagopal. Participants will first receive combination medical therapy with Macitentan tablets taken once daily and Riociguat taken three times daily, followed by BPA, a procedure to open blocked lung arteries. The study compares two groups: those with inoperable CTEPH and those with residual disease after pulmonary endarterectomy (PTE). Treatments and effects will be monitored over time, including before treatment, after up to six months of medical therapy, and after up to twelve months following BPA. During the study, participants will undergo measurements including invasive heart catheterization to assess heart and lung blood flow function, six-minute walk tests, and blood tests for heart stress markers. These assessments will happen at baseline, after medical therapy, and after BPA. The study includes monitoring of hemodynamics, right ventricular-pulmonary artery coupling, and other heart and lung function indicators throughout the study period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Diagnosis of chronic thromboembolic pulmonary hypertension (CTEPH)
  • Not a candidate for pulmonary endarterectomy (PTE) surgery
  • Suitable anatomy and disease burden for balloon pulmonary angioplasty (BPA)
  • No prior treatment for CTEPH or pulmonary arterial hypertension (PAH)
  • Able and willing to give informed consent and follow study schedules
Not Eligible

You will not qualify if you...

  • Moderate to severe heart disease (LVEF less than 45% or severe left ventricular hypertrophy)
  • Sarcoidosis
  • Active cancer
  • Sickle cell anemia
  • Severe liver disease (Childs-Pugh class C)
  • Prisoners
  • Pregnant, planning pregnancy, or breastfeeding
  • Conditions preventing MRI scanning (such as metal in eye, claustrophobia, or inability to lie flat)
  • Allergy or contraindication to riociguat or macitentan
  • Medical or psychological conditions that increase risk or affect ability to follow the study protocol

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 12 months

Participants receive combination medical therapy with Macitentan and Riociguat followed by balloon pulmonary angioplasty (BPA) to improve heart and lung function.

1 baseline visit, visits during up to 6 months of medical therapy, and visits for BPA treatment up to 12 months

Trial Site Locations

Total: 1 location

1

Duke University Medical Center

Durham, North Carolina, United States, 27710

Actively Recruiting

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Research Team

C

Claudia Salazar

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Frequently Asked Questions

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