Improving Outcomes for Hypertensive Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

112 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-30

Study Completion Date

2015-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Approximately 200 children age 6 - \<18 years receiving medications for essential hypertension (HTN) will be recruited from the Pediatric Hypertension Clinic at the time of a routine clinic visit. Participating subjects will be asked to wear the ambulatory blood pressure monitor (ABPM) for 24 hours within 2 weeks of the qualifying visit. Measurements obtained with the ABPM will be compared to measurements obtained by routine clinical procedures documented in the subject's clinical chart. Kappa statistic will be utilized to compare differences in documented BP control between the two measures as well as changes in therapeutic management decisions by treating physicians with the addition of the ABPM readings. The overall goal is to confirm that ABPM leads to an increased detection of uncontrolled HTN along with a similar increase in adjustments increasing anti-hypertensive medication regimens.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Systemic Arterial Hypertension in Pediatric Age.

NCT06797908

Hypertension

RECRUITING

Blood Pressure Control in Juveniles - Longitudinal Study

NCT00005181

Cardiovascular Diseases Heart Diseases Hypertension

COMPLETED

Adolescent Blood Pressure Variation and Ventricular Mass

NCT00005200

Cardiovascular Diseases Heart Diseases Hypertension

COMPLETED

Blood Pressure and Central Vascular Stiffness in Obese Children. Relationship to Metabolic Disturbances and Subclinical Cardiovascular Damage. Effect of Weight Reduction

NCT01310088

Central Blood Pressure Obesity Subclinical Organ Damage +2 more

UNKNOWN NA

Effect of High Blood Pressure and Antihypertensive Treatment on Brain Functioning in Children

NCT00178490

Hypertension

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Age 6-17 years (up to 18th birthday) receiving anti-hypertensive medication(s) by subject history at presentation for the qualifying clinic visit
2. Arm circumference measurement of 15-50 cm (limits of SpaceLabs ABPM cuffs).

Exclusion Criteria

1. Severe HTN which in the opinion of the treating physician would prevent the subject from delaying changes in therapy to complete the study.
2. Secondary HTN from all causes (excluding obesity-related HTN). This includes but is not limited to renovascular HTN, chronic kidney disease, coarctation of the aorta, and monogenic forms of HTN.
3. Physical limitations prohibiting placement of the ABPM monitor.
4. Significant arrhythmias or known disruptions in cardiac output which may interfere with the monitor's ability to detect BP accurately.

Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No