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CompletedNCT00344903Updated Jul 8, 2010

Dallas Heart Study 2: Return Clinic Visit for the Dallas Heart Study Cohort

An observational study in Atherosclerosis, Congestive Heart Failure and Left Ventricular Hypertrophy, sponsored by University of Texas Southwestern Medical Center. Completed at 1 site in United States. Open to participants aged 35 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-07-08.

Sponsored by University of Texas Southwestern Medical Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
3,400
Ages
35 Years to 70 Years
Sex
All
01

Study summary

The Dallas Heart Study (DHS-1) is a large, multi-ethnic, population-based epidemiological study designed to identify determinants of atherosclerotic heart disease (ASHD) in a representative United States (US) urban environment. This study completed enrollment in 2003.

Our objective is to pinpoint factors contributing to progression:

  1. from health to ASHD risk;
  2. from ASHD risk to subclinical ASHD; and
  3. from subclinical to clinical ASHD.

Identification of the critical factors in these transitions will enable targeted implementation of appropriate therapy to interdict before clinical ASHD develops.

Read the detailed description

Early medical intervention in asymptomatic individuals at risk is the most effective strategy to combat atherosclerotic heart disease (ASHD). The major roadblock to effective ASHD prevention is that conventional tools to assess ASHD risk are inadequate and new methods are needed to identify susceptible individuals before the disease process is established. Other successful public-health screening programs have incorporated direct imaging procedures (e.g. mammography, colonoscopy); yet in ASHD, direct imaging of the vasculature has not been incorporated into the risk stratification algorithms.

The Dallas Heart Study (DHS-1) is a large, multi-ethnic, population-based epidemiological study designed to identify determinants of ASHD in a representative US urban environment. This study completed enrollment in 2003.

In DHS-2 we will transform the Dallas Heart Study from a cross-sectional health survey (DHS-1) into a longitudinal cohort study (DHS-2). We will perform state-of-the-art cardiovascular (CV) imaging coupled to biomarkers, genetic markers and classical ASHD risk factors. We will repeat the detailed clinical phenotyping performed between 2000-2003 to capture interval changes in ASHD risk and disease burden. Our objective is to pinpoint factors contributing to progression:

  1. from health to ASHD risk;
  2. from ASHD risk to subclinical ASHD; and
  3. from subclinical to clinical ASHD.

Identification of the critical factors in these transitions will enable targeted implementation of appropriate therapy to interdict before clinical ASHD develops.

02

Conditions studied

  • Atherosclerosis
  • Congestive Heart Failure
  • Left Ventricular Hypertrophy
  • Diabetes Mellitus
  • Hypertension
  • Obesity
  • Metabolic Syndrome X
  • Myocardial Infarction

Keywords

  • Atherosclerosis
  • Heart Failure
  • Ventricular Hypertrophy
  • Myocardial Infarction
  • Screening
  • Hypertension
  • Diabetes
  • Obesity
  • Metabolic Syndrome
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 964 are open to participants now.

This study's enrollment of 3,400 is above the median of 210 across 1,358 observational studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

University of Texas Southwestern Medical Center is the lead sponsor of 990 studies on the registry; 201 are open to participants now.

Of its 135 completed or terminated interventional studies of FDA-regulated products, 100 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Adults who participated in DHS-1. The study will include equal numbers of men and women and will include 50% African Americans

Inclusion criteria

  • Age 35-70
  • Participant in DHS-1 study completing visit 2 (blood sampling) and visit 3 (clinic visit)
  • Provision of informed consent

Exclusion criteria

Exclusion Criteria:

  • None--population study
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
3,400 participants (actual)
Biospecimen retention
Samples with dna
06

Study locations

1 site
  • UT Southwestern Medical Center
    Dallas, Texas 75390-9047, United States
07

References and documents

Publications

  • Victor RG, Haley RW, Willett DL, Peshock RM, Vaeth PC, Leonard D, Basit M, Cooper RS, Iannacchione VG, Visscher WA, Staab JM, Hobbs HH; Dallas Heart Study Investigators. The Dallas Heart Study: a population-based probability sample for the multidisciplinary study of ethnic differences in cardiovascular health. Am J Cardiol. 2004 Jun 15;93(12):1473-80. doi: 10.1016/j.amjcard.2004.02.058. PubMed 15194016 ↗
  • Kay FU, Abbara S, Joshi PH, Garg S, Khera A, Peshock RM. Identification of High-Risk Left Ventricular Hypertrophy on Calcium Scoring Cardiac Computed Tomography Scans: Validation in the DHS. Circ Cardiovasc Imaging. 2020 Feb;13(2):e009678. doi: 10.1161/CIRCIMAGING.119.009678. Epub 2020 Feb 18. PubMed 32066275 ↗
  • Rader F, Franklin SS, Mirocha J, Vongpatanasin W, Haley RW, Victor RG. Superiority of Out-of-Office Blood Pressure for Predicting Hypertensive Heart Disease in Non-Hispanic Black Adults. Hypertension. 2019 Nov;74(5):1192-1199. doi: 10.1161/HYPERTENSIONAHA.119.13542. Epub 2019 Sep 16. PubMed 31522619 ↗
  • Garg S, de Lemos JA, Matulevicius SA, Ayers C, Pandey A, Neeland IJ, Berry JD, McColl R, Maroules C, Peshock RM, Drazner MH. Association of Concentric Left Ventricular Hypertrophy With Subsequent Change in Left Ventricular End-Diastolic Volume: The Dallas Heart Study. Circ Heart Fail. 2017 Aug;10(8):e003959. doi: 10.1161/CIRCHEARTFAILURE.117.003959. PubMed 28775115 ↗
  • Cusano NE, Maalouf NM, Wang PY, Zhang C, Cremers SC, Haney EM, Bauer DC, Orwoll ES, Bilezikian JP. Normocalcemic hyperparathyroidism and hypoparathyroidism in two community-based nonreferral populations. J Clin Endocrinol Metab. 2013 Jul;98(7):2734-41. doi: 10.1210/jc.2013-1300. Epub 2013 May 20. PubMed 23690312 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 8, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00344903
Lead sponsor
University of Texas Southwestern Medical Center
Collaborators
Donald W. Reynolds Foundation
First posted
Jun 27, 2006
Start date
Sep 2007
Primary completion
Sep 2009
Completion
Dec 2009
Last update
Jul 8, 2010

Study contacts

Helen Hobbs, MD
study chair · UT Southwestern Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2009. You cannot join it, but the record below documents what was studied.

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