Completed

Longitudinal Cardiac Outcomes and Body Composition

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What is being collected

Data Collection

Collected at a single point in time - Cross-sectional
No Sample Retained
Who is being recruted

Cardiovascular Diseases

+ Heart Diseases
+ Hypertension
From 20 to 70 Years
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: January 2004

Summary

Principal SponsorVirginia Commonwealth University
Last updated: August 7, 2013
Sourced from a government-validated database.Claim as a partner
Study start date: January 1, 2004Actual date on which the first participant was enrolled.

To relate cardiac structure and blood pressure (BP) elevation in adults to childhood BP and body size and composition. BACKGROUND: To describe growth events adequately, long-term serial data with frequent measurements at appropriate ages are necessary. The study uses the Fels Longitudinal Study. In the Fels Longitudinal Study, data collection begins at birth, and all children are scheduled for measurements semiannually, on their birthdays and half birthdays, until the age of 18 years, after which they are scheduled every 2 years. The Fels study is unique with a rich 70-year history of ongoing serial data collection enabling the analysis of relationships of variables collected in childhood to cardiovascular risk factors well into late adulthood. DESIGN NARRATIVE: The study will link adult cardiac structure and hemodynamic function with long-term serial childhood data for body size, body composition and blood pressure. To address this goal, 685 adult white active participants in the Fels Longitudinal Study, 352 men and 333 women 20 to 70 years of age, will be studied. These adults were selected based on the availability of serial body size data from 2 to 18 years and serial body composition data from 8 to 18 years. Echo cardiographic data for cardiac structure and hemodynamic parameters will be collected from these 685 adults using well defined procedures with a well established quality control and assurance program. The availability of the long-term childhood records of these Fels participants for body size and composition provides a unique opportunity to relate childhood data to subsequent adult data for cardiac structure and blood pressure. The innovative longitudinal statistical analysis used will include covariates such as age, gender, birth year for secular trend, adulthood lifestyle (smoking, alcohol consumption, and physical activity), adult body size and composition, menopause, and medical condition and medication use. The analysis of the hypotheses in this study links cardiac structure and hemodynamic parameters in adulthood to childhood growth and body composition. Such linkages will reveal how various growth and body composition profiles and patterns during childhood can lead either to pathological or to healthy cardiac structure and hemodynamic parameters in adulthood. Understanding adult cardiac outcomes in response to changes in fat and fat-free mass from childhood into adulthood will provide important clues about potential physiologic mechanisms underlying the observed changes in body mass index (BMI). Elucidating adverse relationships through such a linkage can lead to the early identification of children at high risk for adult cardiovascular disease. This investigation will relate direct measures of body composition to adult cardiac structure and hemodynamic parameters.

Official TitleLongitudinal Cardiac Outcomes and Body Composition 
Principal SponsorVirginia Commonwealth University
Last updated: August 7, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
715 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Cohort
These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

What happens to patients' samples
No samples are kept after the study. Researchers will not store or use any of your biological materials in the future.

Other Options for Sample Use
Samples With DNA
: Samples are kept and may be used for genetic research.

Samples Without DNA
: Samples are kept but not usable for DNA analysis.

How participants are selected
Participants are chosen using a random method, so everyone has a known and fair chance of being selected. This approach helps ensure the results reflect the broader population.
Another way to select participants is through a non-probability sample, where participants are selected without randomization, often based on availability or willingness to take part.

How information is collected
Researchers collect data at a single point in time, offering a snapshot of health, exposures, or conditions in a specific population. These studies are useful for understanding current patterns and prevalence.Other Ways to Collect Data
Prospective
: These studies collect new data moving forward over time.

Retrospective
: These studies use existing medical records or past data.

Others
: Some studies use a mix of approaches or less common designs depending on the research goal.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 20 to 70 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Cardiovascular Diseases
Heart Diseases
Hypertension
Criteria

No eligibility criteria


Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives
Study Objectives
Primary Objectives

Investigators are currently finishing an investigation of racial divergence in cardiac structure, cardiac function and blood pressure in relationship to child growth from 9 to 18 years in 700 women who were participants in the National Growth and Health Study participants. Preliminary results show that women who were overweight during childhood (25 ≤ BMI \< 30 kg/m2) had a significantly larger LVM and elevated systolic blood pressure (SBP) at age 22 years than women who were not overweight during childhood. Women who had elevated SBP during childhood had a significantly larger LVM and elevated SBP at age 22 years than women who did not have elevated SBP values during childhood.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has no location dataSave this study to your profile to know when the location data is available. 

CompletedNo study centers