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Cardiovascular DiseaseHCHS/SOLNCT02060344

Hispanic Community Health Study / Study of Latinos

An observational study of Cardiovascular Disease, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The Hispanic Community Health Study / Study of Latinos (HCHS/SOL) is a multi-center epidemiologic study in Hispanic/Latino populations to determine the role of acculturation in the prevalence and development of disease, and to identify risk factors playing a protective or harmful role in Hispanics/Latinos. Read more about this study

Who is it for?
Ages 18 to 74 yearsHealthy volunteers can take part
Conditions the study is for
Cardiovascular Disease
How many people
16,400 participants
Where
1 siteUnited States
Study dates
Jan 2006to Nov 2032
Phase
Observational
Are there results?
Not yet: the study is under way

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 18 to 74 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: The of over 16,400 persons of Hispanic/Latino origin, specifically Cuban, Puerto Rican, Mexican, and Central/South American, to be recruited through four Field Centers affiliated with San Diego State University, Northwestern University in Chicago, Albert Einstein College of Medicine in the Bronx area of New York, and the University of Miami.

Who may be able to join

  • Hispanic/Latino persons living in the US, aged 18-74 in four communities: San Diego, Bronx NY, Chicago, and Miami.Examination of the cohort following a standardized protocol

Who cannot join

  • Plans to move from the region within 6 months.
  • Unable to complete the study questionnaires in English or Spanish.
  • Women who are pregnant.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

Other trials in United States

About this study

Official title: Hispanic Community Health Study / Study of Latinos (HCHS/SOL)

The Hispanic Community Health Study / Study of Latinos (HCHS/SOL) is a multi-center epidemiologic study in Hispanic/Latino populations to determine the role of acculturation in the prevalence and development of disease, and to identify risk factors playing a protective or harmful role in Hispanics/Latinos.

Read the detailed description

Study goals include studying the prevalence and development of disease in Hispanics/Latinos, the role of acculturation, and to identify risk factors that play protective or harmful roles in Hispanics/Latinos. The target population of 16,000 persons of Hispanic/Latino origin, specifically Cuban, Puerto Rican, Mexican, and Central/South American, to be recruited through four Field Centers affiliated with San Diego State University, Northwestern University in Chicago, Albert Einstein College of Medicine in the Bronx area of New York, and the University of Miami. Seven additional academic centers serve as scientific and logistical support centers.

Study participants aged 18-74 years underwent an extensive clinic exam and assessments to determine baseline risk factors. Annual follow-up interviews will be conducted for 2-4 years to determine health outcomes of interest. Study results will be disseminated through scientific journals and also conveyed to the communities involved in the study in order to improve public health at the local level. Annual follow-up interviews will be conducted for 2-4 years to determine health outcomes of interest. Study results will be disseminated through scientific journals and also conveyed to the communities involved in the study in order to improve public health at the local level.

Keywords
Cardiovascular Disease, Hispanic, Latinos
Medical subject headings
Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02060344
Study groupRoleWhat they receive
Hispanic/Latinos residing in the USThe cohort consists of over 16,400 persons of Hispanic/Latino origin, ages 18-74, specifically Cuban, Puerto Rican, Mexican, and Central/South American, to be recruited through four Field Centers affiliated with San Diego State University, Northwestern University in Chicago, Albert Einstein College of Medicine in the Bronx area of New York, and the University of Miami.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prevalence of cardiovascular and pulmonary disease risk factors in Hispanics/Latinos

    This is a population-based cohort study of 16,400 Hispanic/Latinos. Objectives:

    • Examination of the cohort following a standardized protocol
    • Follow-up of the cohort to assess vital status, changes in health status, medication intake, and new cardiovascular and pulmonary events (fatal and non-fatal MI, heart failure, stroke, asthma, and COPD.
    • Understand the relationship between changes in risk factors and protective factors and onset of CV and pulmonary disease progression
    • Understand the relationship between changes in sociocultural factors and changes in health
    • Understand the relationship between baseline CV risk profile of women of childbearing age and incidence of select pregnancy complications

    Measured: Visit 2 data collection through 2019, preliminary and final analyses through 2019, Annual Follow-up through 2019

Timeline

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

  1. First posted12 Feb 2014 (estimated)
  2. Study startJan 2006
  3. Primary completionNov 2032 (estimated)
  4. Study completionNov 2032 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
16,400 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02060344
Sponsor's protocol ID
HCHS-SOL
Other IDs
HHSN268201300001I, HHSN268201300002I, HHSN268201300003I, HHSN268201300004I, HHSN268201300005I, HHSN268201300024C
Acronym
HCHS/SOL
Status last verified
Jun 2025
First submitted
31 Jan 2014
Last updated
24 Jun 2025
Results posted
No
Data monitoring committee
Yes

Publications

  • Sorlie PD, Aviles-Santa LM, Wassertheil-Smoller S, Kaplan RC, Daviglus ML, Giachello AL, Schneiderman N, Raij L, Talavera G, Allison M, Lavange L, Chambless LE, Heiss G. Design and implementation of the Hispanic Community Health Study/Study of Latinos. Ann Epidemiol. 2010 Aug;20(8):629-41. doi: 10.1016/j.annepidem.2010.03.015.

    PubMed 20609343
  • Isasi CR, Gallo LC, Cai J, Gellman MD, Xie W, Heiss G, Kaplan RC, Talavera GA, Daviglus ML, Pirzada A, Wassertheil-Smoller S, Llabre MM, Youngblood ME, Schneiderman N, Perez-Stable EJ, Napoles AM, Perreira KM. Economic and Psychosocial Impact of COVID-19 in the Hispanic Community Health Study/Study of Latinos. Health Equity. 2023 Mar 27;7(1):206-215. doi: 10.1089/heq.2022.0211. eCollection 2023.

    PubMed 37007686
  • Alvarez CS, Aviles-Santa ML, Freedman ND, Perreira KM, Garcia-Bedoya O, Kaplan RC, Daviglus ML, Graubard BI, Talavera GA, Thyagarajan B, Camargo MC. Associations of Helicobacter pylori and hepatitis A seropositivity with asthma in the Hispanic Community Health Study/Study of Latinos (HCHS/SOL): addressing the hygiene hypothesis. Allergy Asthma Clin Immunol. 2021 Nov 24;17(1):120. doi: 10.1186/s13223-021-00625-3.

    PubMed 34819160
  • Maldonado LE, Adair LS, Sotres-Alvarez D, Mattei J, Mossavar-Rahmani Y, Perreira KM, Daviglus ML, Van Horn LV, Gallo LC, Isasi CR, Albrecht SS. Dietary Patterns and Years Living in the United States by Hispanic/Latino Heritage in the Hispanic Community Health Study/Study of Latinos (HCHS/SOL). J Nutr. 2021 Sep 4;151(9):2749-2759. doi: 10.1093/jn/nxab165.

    PubMed 34320207
  • Bai F, Chen J, Pandey D, Durazo-Arvizu R, Talavera GA, Allison MA, Perreira KM, Schneiderman N, Sutherland MW, Cai J, Daviglus ML, Testai FD. Stroke Risk Factor Status and Use of Stroke Prevention Medications Among Hispanic/Latino Adults in HCHS/SOL. Stroke. 2021 Apr;52(4):1339-1346. doi: 10.1161/STROKEAHA.120.031216. Epub 2021 Mar 4.

    PubMed 33657859
  • Chen GC, Qi Q, Hua S, Moon JY, Spartano NL, Vasan RS, Sotres-Alvarez D, Castaneda SF, Evenson KR, Perreira KM, Gallo LC, Pirzada A, Diaz KM, Daviglus ML, Gellman MD, Kaplan RC, Xue X, Mossavar-Rahmani Y. Accelerometer-assessed physical activity and incident diabetes in a population covering the adult life span: the Hispanic Community Health Study/Study of Latinos. Am J Clin Nutr. 2020 Nov 11;112(5):1318-1327. doi: 10.1093/ajcn/nqaa232.

    PubMed 32910816
  • Chen GC, Chai JC, Yu B, Michelotti GA, Grove ML, Fretts AM, Daviglus ML, Garcia-Bedoya OL, Thyagarajan B, Schneiderman N, Cai J, Kaplan RC, Boerwinkle E, Qi Q. Serum sphingolipids and incident diabetes in a US population with high diabetes burden: the Hispanic Community Health Study/Study of Latinos (HCHS/SOL). Am J Clin Nutr. 2020 Jul 1;112(1):57-65. doi: 10.1093/ajcn/nqaa114.

    PubMed 32469399
  • Elfassy T, Mossavar-Rahmani Y, Van Horn L, Gellman M, Sotres-Alvarez D, Schneiderman N, Daviglus M, Beasley JM, Llabre MM, Shaw PA, Prado G, Florez H, Zeki Al Hazzouri A. Associations of Sodium and Potassium with Obesity Measures Among Diverse US Hispanic/Latino Adults: Results from the Hispanic Community Health Study/Study of Latinos. Obesity (Silver Spring). 2018 Feb;26(2):442-450. doi: 10.1002/oby.22089. Epub 2018 Jan 10.

    PubMed 29318759
  • Corsino L, Sotres-Alvarez D, Butera NM, Siega-Riz AM, Palacios C, Perez CM, Albrecht SS, Espinoza Giacinto RA, Perera MJ, Horn LV, Aviles-Santa ML. Association of the DASH dietary pattern with insulin resistance and diabetes in US Hispanic/Latino adults: results from the Hispanic Community Health Study/Study of Latinos (HCHS/SOL). BMJ Open Diabetes Res Care. 2017 Jul 7;5(1):e000402. doi: 10.1136/bmjdrc-2017-000402. eCollection 2017.

    PubMed 28761660
  • Mattei J, Sotres-Alvarez D, Daviglus ML, Gallo LC, Gellman M, Hu FB, Tucker KL, Willett WC, Siega-Riz AM, Van Horn L, Kaplan RC. Diet Quality and Its Association with Cardiometabolic Risk Factors Vary by Hispanic and Latino Ethnic Background in the Hispanic Community Health Study/Study of Latinos. J Nutr. 2016 Oct;146(10):2035-2044. doi: 10.3945/jn.116.231209. Epub 2016 Sep 7.

    PubMed 27605403
  • Wong WW, Strizich G, Heo M, Heymsfield SB, Himes JH, Rock CL, Gellman MD, Siega-Riz AM, Sotres-Alvarez D, Davis SM, Arredondo EM, Van Horn L, Wylie-Rosett J, Sanchez-Johnsen L, Kaplan RC, Mossavar-Rahmani Y. Relationship between body fat and BMI in a US hispanic population-based cohort study: Results from HCHS/SOL. Obesity (Silver Spring). 2016 Jul;24(7):1561-71. doi: 10.1002/oby.21495. Epub 2016 May 17.

    PubMed 27184359
  • Oelsner EC, Loehr LR, Henderson AG, Donohue KM, Enright PL, Kalhan R, Lo Cascio CM, Ries A, Shah N, Smith BM, Rosamond WD, Barr RG. Classifying Chronic Lower Respiratory Disease Events in Epidemiologic Cohort Studies. Ann Am Thorac Soc. 2016 Jul;13(7):1057-66. doi: 10.1513/AnnalsATS.201601-063OC.

    PubMed 27088163
  • Mossavar-Rahmani Y, Jung M, Patel SR, Sotres-Alvarez D, Arens R, Ramos A, Redline S, Rock CL, Van Horn L. Eating behavior by sleep duration in the Hispanic Community Health Study/Study of Latinos. Appetite. 2015 Dec;95:275-84. doi: 10.1016/j.appet.2015.07.014. Epub 2015 Jul 16.

    PubMed 26189885
  • Mossavar-Rahmani Y, Shaw PA, Wong WW, Sotres-Alvarez D, Gellman MD, Van Horn L, Stoutenberg M, Daviglus ML, Wylie-Rosett J, Siega-Riz AM, Ou FS, Prentice RL. Applying Recovery Biomarkers to Calibrate Self-Report Measures of Energy and Protein in the Hispanic Community Health Study/Study of Latinos. Am J Epidemiol. 2015 Jun 15;181(12):996-1007. doi: 10.1093/aje/kwu468. Epub 2015 May 20.

    PubMed 25995289
  • Siega-Riz AM, Sotres-Alvarez D, Ayala GX, Ginsberg M, Himes JH, Liu K, Loria CM, Mossavar-Rahmani Y, Rock CL, Rodriguez B, Gellman MD, Van Horn L. Food-group and nutrient-density intakes by Hispanic and Latino backgrounds in the Hispanic Community Health Study/Study of Latinos. Am J Clin Nutr. 2014 Jun;99(6):1487-98. doi: 10.3945/ajcn.113.082685. Epub 2014 Apr 23.

    PubMed 24760972

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiovascular Disease, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.

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

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. 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: under way, not looking for participants, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

This study is still under way. Results are not available in the source record yet.

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.

What does the primary outcome measure?

Prevalence of cardiovascular and pulmonary disease risk factors in Hispanics/Latinos (time frame: Visit 2 data collection through 2019, preliminary and final analyses through 2019, Annual Follow-up through 2019). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02060344, which also lists 15 linked publications.

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 24 Jun 2025.

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