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Cardiovascular DiseasesNCT00005470

Divergence of Blood Pressure By Race in Adolescent Girls

An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To continue examinations of 670 girls enrolled in the National Growth and Health Study (NGHS) for four more years, adding measurements of total peripheral resistance, cardiac output, DEXA scans for fat-free mass and fat mass, left ventricular mass and geometry, circulating blood volume, whole blood viscosity, and left… Read more about this study

Who is it for?
Ages Up to 100 years, men only
How many people
Not given
Where
No sites listed yet
Study dates
Sep 1996to Aug 2002
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 100 years
  • Men only
  • No healthy volunteers
  • Child, Adult, Older adult

No eligibility criteria

About this study

To continue examinations of 670 girls enrolled in the National Growth and Health Study (NGHS) for four more years, adding measurements of total peripheral resistance, cardiac output, DEXA scans for fat-free mass and fat mass, left ventricular mass and geometry, circulating blood volume, whole blood viscosity, and left ventricular contractility.

Read the detailed description

BACKGROUND:

African-American women have a substantially higher prevalence of hypertension and suffer greater morbidity and mortality due to blood pressure elevation than white-American women. Much of this ethnic difference in blood pressure is due to increased obesity in African-American women. In contrast, young African-American and white-American girls have similar levels of obesity and blood pressure. The hemodynamic changes that occur with developing obesity and result in this ethnic difference in blood pressure have not been well characterized. Cross-sectional studies of adolescents have shown that despite similar blood pressure levels, African-Americans have higher total peripheral resistance while whites have higher cardiac output. Cross-sectional studies of adults show that obesity is associated with elevation of cardiac output. If such an obesity-related increase in cardiac output is superimposed on the underlying elevation of total peripheral resistance in African-American girls, these hemodynamic factors could be responsible for the developing ethnic divergence in blood pressure seen in late adolescence as African-American girls develop an increasing prevalence and severity of obesity.

This investigation will provide important new knowledge regarding the longitudinal changes and interrelationships among the potential hemodynamic factors which define the association between developing obesity and blood pressure elevation. In the clinical setting where obesity is very difficult to prevent or treat, it is important to understand the mechanisms by which obesity results in elevated blood pressure. The results of this cohort study will provide the basis for rational and specific clinical strategies to interrupt the pathophysiologic process by which obesity leads to hypertension and places African-American women at particularly increased risk for cardiovascular disease morbidity and mortality.

The NGHS was initiated by the NHLBI in 1985 as a contract-supported program to determine if the Black-white differences in the development of obesity in 2,379 pubescent females were due to differences in psychosocial, socioeconomic and other environmental factors. The study also sought to determine whether differences in the development of obesity led to Black-white differences in other coronary heart disease risk factors, such as blood pressure and serum lipids. The study has been renewed twice, the last time as an investigator-initiated study. See the National Growth and Health Study for the complete write-up.

DESIGN NARRATIVE:

The ancillary study is a prospective cohort study of 355 African-American and 315 white-American females from the NHLBl Growth and Health Study as these women progress from age 18-19 years to age 21-22 years. The study includes yearly measurement of anthropometrics, blood pressure, and echocardiographic determination of cardiac output and total peripheral resistance. In addition, factors which may relate to changes in cardiac output and total peripheral resistance, such as circulating blood volume (left ventricular end-diastolic volume), heart rate, left ventricular contractility, whole blood viscosity, and left ventricular mass and geometry are measured.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Medical subject headings
Cardiovascular Diseases, Heart Diseases, Hypertension, Obesity

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2000 (estimated)
  2. Study startSep 1996
  3. Study completionAug 2002

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
IDs, dates and publications
ClinicalTrials.gov ID
NCT00005470
Sponsor's protocol ID
4952
Other IDs
R01HL052911
Status last verified
Aug 2004
First submitted
25 May 2000
Last updated
18 Feb 2016
Results posted
No

Publications

  • Kimm SY, Glynn NW, Aston CE, Poehlman ET, Daniels SR. Effects of race, cigarette smoking, and use of contraceptive medications on resting energy expenditure in young women. Am J Epidemiol. 2001 Oct 15;154(8):718-24. doi: 10.1093/aje/154.8.718.

    PubMed 11590084

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00005470, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2016.

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