Hypertensive Treatment and Epidemiological Analyses

February 17, 2016 updated by: National Heart, Lung, and Blood Institute (NHLBI)
To determine the impact of the treatment of hypertension on the epidemiological analyses of blood pressure from observational studies.

Study Overview

Status

Completed

Conditions

Detailed Description

BACKGROUND:

With the use of antihypertensive medication increasing steadily over the last 25 years, treatment for hypertension is now common. Given the high prevalence of treatment for hypertension, researchers can no longer assume that participants in epidemiologic studies represent natural blood pressure measures, as opposed to treated blood pressure measures. The effect of this high prevalence of treatment, however, has not been fully investigated. Although it might seem that studies of "natural history" are no longer relevant, great interest currently exists in establishing both environmental and genetic determinants of blood pressure. Additionally, there currently is a renewed interest in refining treatment guidelines. For example, the need to account for absolute as well as relative risk has been hotly debated in recent years. The need will continue to exist, therefore, to analyze observational data sets to meet the evolving interest in the determinants of blood pressure and to meet the requirements for more refined risk estimates.

DESIGN NARRATIVE:

To investigate the effect of blood pressure treatment on the analysis of epidemiologic studies, the investigators conducted two interrelated analyses using simulation studies and data from five observational studies: The Framingham Heart Study; the NHANES I, II, and III cohorts; and The International Collaborative Study of Hypertension in Blacks (ICSHIB). They first conducted simulation studies to examine the behavior of different methodologies in each of two common analytic settings: relating body mass index to level of systolic blood pressure and relating level of systolic blood pressure to coronary heart disease mortality. They planned to use the data from the five studies to derive the parameters for use in the simulation studies. In these studies they quantified the level of bias that results from ignoring the presence of blood pressure treatment in observational data. After conducting their simulations studies, they repeated the analysis of the relationship between body mass index and systolic blood pressure using available empirical data.

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

Study Type

Observational

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.

Eligibility Criteria

Ages Eligible for Study

No older than 100 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

No eligibility criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

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 Major Dates

Study Start

September 1, 1998

Study Completion (Actual)

August 1, 2000

Study Registration Dates

First Submitted

May 25, 2000

First Submitted That Met QC Criteria

May 25, 2000

First Posted (Estimate)

May 26, 2000

Study Record Updates

Last Update Posted (Estimate)

February 18, 2016

Last Update Submitted That Met QC Criteria

February 17, 2016

Last Verified

December 1, 2000

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5019
  • R03HL059155 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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