ACTIVE_NOT_RECRUITING

Office, Home, and Ambulatory Blood Pressure

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

This will be a prospective observational study. The population would be pediatric patients 6 years to \<19 years of age who were referred for elevated blood pressure to investigate if home blood pressure (HBP) can determine blood pressure phenotype (normotensive, hypertensive, masked hypertension, white coat hypertension) as accurately as ambulatory blood pressure monitor (ABPM) in childhood and adolescence.

Official Title

Office, Home, and Ambulatory Blood Pressure Measurements in Pediatric Patients

Quick Facts

Study Start:2022-03-24
Study Completion:2026-09-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05297708

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:6 Years to 19 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Not specified
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age 6 years to \<19 years old;
  2. 2. Elevated blood pressure defined as 15% lower than the 95%ile BP based on clinical practice guidelines(CPG) but less than stage II hypertension based on CPG;
  3. 3. Tolerate ABPM 24 hours;
  4. 4. Tolerate HBP; and
  5. 5. Can have diabetes mellitus, obstructive sleep apnea, and attention deficit hyperactivity disorder managed by medication.
  6. 6. On stable doses of medications known to affect BP such as:
  7. 1. Corticosteroids
  8. 2. Calcineurin inhibitors
  9. 3. Oral decongestants;
  10. 7. Clinically stable
  1. 1. On antihypertension medications or treated in the last 6 months;
  2. 2. Pregnant;
  3. 3. Structural heart disease such as:
  4. 1. Obstructive valvular disease
  5. 2. Coarctation of the aorta
  6. 3. Cardiomyopathy;
  7. 4. Other secondary causes such as:
  8. 1. Renal artery stenosis
  9. 2. Neurological condition with dysautonomia;
  10. 5. Recent initiation of medications known to affect BP such as:
  11. 1. Corticosteroids
  12. 2. Calcineurin inhibitors
  13. 3. Oral decongestants;

Contacts and Locations

Principal Investigator

Elaine Urbina
PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati

Study Locations (Sites)

Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
United States

Collaborators and Investigators

Sponsor: Children's Hospital Medical Center, Cincinnati

  • Elaine Urbina, PRINCIPAL_INVESTIGATOR, Children's Hospital Medical Center, Cincinnati

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 Date2022-03-24
Study Completion Date2026-09-01

Study Record Updates

Study Start Date2022-03-24
Study Completion Date2026-09-01

Terms related to this study

Additional Relevant MeSH Terms

  • Elevated Blood Pressure