Hypertensive Treatment and Epidemiological Analyses

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00005501
First received: May 25, 2000
Last updated: February 17, 2016
Last verified: December 2000
  Purpose
To determine the impact of the treatment of hypertension on the epidemiological analyses of blood pressure from observational studies.

Condition
Cardiovascular Diseases
Hypertension
Heart Diseases
Coronary Disease

Study Type: Observational

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: September 1998
Study Completion Date: August 2000
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.

  Eligibility

Ages Eligible for Study:   up to 100 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria
No eligibility criteria
  Contacts and Locations
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No Contacts or Locations Provided
  More Information

ClinicalTrials.gov Identifier: NCT00005501     History of Changes
Other Study ID Numbers: 5019  R03HL059155 
Study First Received: May 25, 2000
Last Updated: February 17, 2016
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cardiovascular Diseases
Coronary Artery Disease
Coronary Disease
Arterial Occlusive Diseases
Arteriosclerosis
Heart Diseases
Myocardial Ischemia
Vascular Diseases

ClinicalTrials.gov processed this record on April 27, 2016