ACTIVE_NOT_RECRUITING

Mono vs. Dual Therapy for Pediatric Pulmonary Arterial Hypertension

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Conditions

Pediatric Pulmonary Hypertension

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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 investigators' central hypothesis is that early combination therapy with two PAH-specific oral therapies that have been shown to be well tolerated in the pediatric population, sildenafil and bosentan, will result in better World Health Organization (WHO) functional class at 12 months after initiation of PAH treatment than therapy with sildenafil alone.

Official Title

Kids MoD PAH Trial: Mono- vs. Duo-Therapy for Pediatric Pulmonary Arterial Hypertension

Quick Facts

Study Start:2022-08-01
Study Completion:2026-05-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04039464

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:3 Months to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Lewis Romer, MD
PRINCIPAL_INVESTIGATOR
Johns Hopkins University

Study Locations (Sites)

Children's Hospital Colorado
Aurora, Colorado, 80045
United States
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, 33701
United States
Johns Hopkins Medical Institutions
Baltimore, Maryland, 21287
United States
Boston Children's Hospital
Boston, Massachusetts, 02115
United States
Columbia University Medical Center
New York, New York, 10032
United States
New York Medical College
Valhalla, New York, 10595
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
Seattle Children's Hospital
Seattle, Washington, 98105
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

  • Lewis Romer, MD, PRINCIPAL_INVESTIGATOR, Johns Hopkins 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 Date2022-08-01
Study Completion Date2026-05-30

Study Record Updates

Study Start Date2022-08-01
Study Completion Date2026-05-30

Terms related to this study

Additional Relevant MeSH Terms

  • Pediatric Pulmonary Hypertension