RECRUITING

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

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Conditions

CTEPHInoperablePost-PTE

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-01-27
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05140525

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age ≥ 18 years' old
  2. 2. Diagnosis of CTEPH
  3. 3. Not a candidate for PTE
  4. 4. Candidate for BPA based on suitable anatomy and disease burden
  5. 5. 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.
  6. 6. Willing and able to give informed consent and adhere to visit/protocol schedules (Consent must be given before any study procedures are performed).
  1. * Subjects presenting with any of the following will not be included in the trials:
  2. 1. Moderate to severe heart disease (LVEF \< 45% or severe LV Hypertrophy)
  3. 2. Sarcoidosis
  4. 3. Active cancer
  5. 4. Sickle cell anemia
  6. 5. Liver disease (Childs-Pugh class C)
  7. 6. Prisoners
  8. 7. Pregnant, planning pregnancy or lactating
  9. 8. Conditions that will prohibit MRI scanning (metal in eye, claustrophobia, inability to lie supine)
  10. 9. Contraindication to riociguat or macitentan
  11. 10. 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

Contacts and Locations

Study Contact

David Ptashnik, MS
CONTACT
9196682642
david.ptashnik@duke.edu

Principal Investigator

Sudarshan Rajagopal, MD, PhD
PRINCIPAL_INVESTIGATOR
Duke Health System

Study Locations (Sites)

Duke University Medical Center
Durham, North Carolina, 27710
United States

Collaborators and Investigators

Sponsor: Dr Sudarshan Rajagopal

  • Sudarshan Rajagopal, MD, PhD, PRINCIPAL_INVESTIGATOR, Duke Health System

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-27
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2025-01-27
Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

  • Inoperable
  • Post-PTE

Additional Relevant MeSH Terms

  • CTEPH