RECRUITING

Pulmonary Hypertension SOLAR

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 develop a noninvasive signature for pulmonary vascular remodeling in Group 3 PH patients, using hyperpolarized 129Xe magnetic resonance imaging (129Xe MRI). Such a signature may identify Group 3 PH responders to PAH-specific therapies. PAH's unique 129Xe MRI signature has been shown in previous studies. Past studies have lacked a pathologic "ground truth" correlate of these signatures, which could be provided by comparing them with the pathology of lung explant tissue from patients who have undergone a lung transplant. This signature could be validated in a cohort of patients with Group 3 PH in future studies.

Official Title

Defining a Noninvasive Signature for Pulmonary Vascular Remodeling in Group 3 PH

Quick Facts

Study Start:2023-11-08
Study Completion:2024-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04778046

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. Be on the lung transplant waiting list at Duke University Medical Center.
  3. 3. PH as defined by RHC - mPAP \> 20 mmHg, PVR \> 3 WU, PCWP \< 15 mmHg
  4. 4. Groups defined as:
  5. 5. Willing and able to give informed consent and adhere to visit/protocol schedules (consent must be given before any study procedures are performed).
  1. 1. Moderate to severe heart disease (LVEF \< 45% or severe LV Hypertrophy).
  2. 2. Sarcoidosis.
  3. 3. Active cancer.
  4. 4. Sickle cell anemia.
  5. 5. Liver disease (Childs-Pugh class C).
  6. 6. Prisoners and pregnant women will not be approached for the study.
  7. 7. Inability to obtain consent.
  8. 8. Conditions that will prohibit MRI scanning (metal in eye, claustrophobia, inability to lie supine).
  9. 9. 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
919-668-2642
david.ptashnik@duke.edu

Principal Investigator

Sudarshan Rajagopal, MD, PhD
PRINCIPAL_INVESTIGATOR
Duke University

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Bastiaan Driehuys

  • Sudarshan Rajagopal, MD, PhD, PRINCIPAL_INVESTIGATOR, Duke University

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 Date2023-11-08
Study Completion Date2024-12-30

Study Record Updates

Study Start Date2023-11-08
Study Completion Date2024-12-30

Terms related to this study

Keywords Provided by Researchers

  • Lung Transplant
  • Group 3 PH

Additional Relevant MeSH Terms

  • Interstitial Lung Disease
  • COPD
  • Pulmonary Arterial Hypertension