A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti

NCT ID: NCT03892265

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 3005 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-03-08
• Study Completion Date: 2028-08-01

Brief Summary

Investigators will establish a longitudinal cohort of ~3,000 adults >18 years in Port-au-Prince using multistage random sampling, and follow them longitudinally to evaluate the prevalence and incidence of cardiovascular disease risk factors and diseases. Cardiovascular risk factors include hypertension, diabetes, obesity, dyslipidemia, kidney disease, poor diet, cigarette smoking, physical inactivity, and inflammation. Cardiovascular disease include angina and myocardial infarction, heart failure, stroke, and CVD mortality. It is anticipated that hypertension prevalence will be ≥10% in 18-30 year olds, that hypertension incidence will be >10 events/1000 person years. Association of determinants and risk factors with CVD will also be examined. Whole blood, serum, plasma, stool, and urine samples will be biobanked for future studies.

Detailed Description

Investigators propose a longitudinal observational study which includes establishing a population-based longitudinal cohort to determine the prevalence and incidence of cardiovascular risk factors and diseases in Haiti. Cardiovascular risk factors include hypertension, diabetes, obesity, kidney disease, dyslipidemia, smoking, alcohol use, physical inactivity, poor diet, and inflammation. Cardiovascular diseases include angina and myocardial infarction, heart failure, stroke and cardiac death. The cohort will include ~3,000 adults (>18 years) living in Port-au-Prince who will be followed longitudinally. Participants will be selected via multistage random sampling using census blocks . The GHESKIO Community Advisory Board and GHESKIO community health workers (CHWs) will conduct community sensitization about the study prior to study recruitment. CHWs will introduce the study to selected households and individuals, who will then be referred to the research team at GHESKIO for informed consent and study enrollment procedures. Participants will complete the study enrollment, 12- and 24-month, in addition to subsequent annual study visits at GHESKIO. These study visits include a study questionnaire, measurement of blood pressure and assessment for cardiovascular symptoms and events. Laboratory measures and an electrocardiogram will be done at study enrollment and the 24-month visit, and subsequently every 2 years. Participants will also provide blood, urine and stool samples for biobanking at study enrollment. Blood and urine will be collected at 24, 48 and 72 months, with stool also collected at 72 months. CHWs will perform home visits every 6 months on all participants to update locator information, measure blood pressure, and ask about cardiovascular symptoms and events. CHWs will also call the participant every three months to confirm contact information. Any participant who reports a cardiovascular symptom or event to research staff at any time during the study will be referred to the GHESKIO clinic or to a GHESKIO-affiliate hospital for clinical care. The research team will abstract data from medical records of referred patients on information regarding diagnosis codes, laboratory results, diagnostic imaging and cause of death.

Conditions

Hypertension; Diabetes; Obesity; Kidney Diseases; Dyslipidemias; Smoking; Alcohol Use, Unspecified; Physical Inactivity; Poor Diet; Inflammation; Myocardial Infarction; Heart Failure; Stroke; Cardiac Death

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Observational Study

No intervention is included in this observational study.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• age > or = 18 years, primary residence in the study area of Port-au-Prince (defined as having slept at the household at least once in the past two weeks and considers the household their primary residence with no plans to move in the next 24 months),
• able to provide consent for study procedures,
• agrees to study procedures, and
• willing to be contacted at a new residence if a move occurs

Exclusion Criteria

• serious medical conditions or cognitive impairment preventing study participation as judged by research physicians,
• unable to speak and understand French or Creole.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic

OTHER

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Margaret McNairy, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Jean W Pape, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Cornell Medical College /Les Centres GHESKIO

Locations

Les Centres GHESKIO

Port-au-Prince, West, Haiti

Countries

Haiti

References

Metz M, Pierre JL, Yan LD, Rouzier V, St-Preux S, Exantus S, Preval F, Roberts N, Tymejczyk O, Malebranche R, Deschamps MM, Pape JW, McNairy ML. Hypertension continuum of care: Blood pressure screening, diagnosis, treatment, and control in a population-based cohort in Haiti. J Clin Hypertens (Greenwich). 2022 Mar;24(3):246-254. doi: 10.1111/jch.14399. Epub 2022 Feb 24.

Reference Type: BACKGROUND

PMID: 35199944 (View on PubMed)

Sufra R, Lookens Pierre J, Dade E, Rouzier V, Apollon A, St Preux S, Preval F, Inddy J, Metz M, Tymejczyk O, Nash D, Malebranche R, Deschamps M, Pape JW, Goncalves MD, McNairy ML, Yan LD. Diabetes Epidemiology Among Adults in Port-au-Prince, Haiti: A Cross-Sectional Study. Front Endocrinol (Lausanne). 2022 Feb 24;13:841675. doi: 10.3389/fendo.2022.841675. eCollection 2022.

Reference Type: BACKGROUND

PMID: 35282460 (View on PubMed)

Clermont A, Sufra R, Pierre JL, Mourra MN, Fox EL, Rouzier V, Dade E, St-Preux S, Inddy J, Erline H, Obed FP, Yan LD, Metz M, Lee MH, Fitzgerald DW, Deschamps MM, Pape JW, McNairy ML. Dietary Risk Factors for Cardiovascular Disease among Low-Income Haitian Adults: Findings from a Population-Based Cohort. Nutrients. 2022 Feb 13;14(4):787. doi: 10.3390/nu14040787.

Reference Type: BACKGROUND

PMID: 35215437 (View on PubMed)

Yan LD, Rouzier V, Pierre JL, Lee MH, Muntner P, Parsons PJ, Apollon A, St-Preux S, Malebranche R, Pierre G, Emmanuel E, Nash D, Kingery J, Walsh KF, Smith CE, Metz M, Tymejczyk O, Deschamps M, Pape JW, Fitzgerald DW, McNairy ML. High Lead Exposure Associated With Higher Blood Pressure in Haiti: a Warning Sign for Low-Income Countries. Hypertension. 2022 Jan;79(1):283-290. doi: 10.1161/HYPERTENSIONAHA.121.18250. Epub 2021 Nov 17.

Reference Type: BACKGROUND

PMID: 34878898 (View on PubMed)

Lookens J, Tymejczyk O, Rouzier V, Smith C, Preval F, Joseph I, Baptiste RJ, Victor J, Severe P, Apollon S, Dumont E, Forestal G, St Preux S, Rivera V, Seo G, Charles B, Ariste W, Kingery J, Devieux J, Koenig S, Nash D, Fitzgerald D, Safford M, Deschamps MM, Pape J, McNairy M. The Haiti cardiovascular disease cohort: study protocol for a population-based longitudinal cohort. BMC Public Health. 2020 Nov 1;20(1):1633. doi: 10.1186/s12889-020-09734-x.

Reference Type: BACKGROUND

PMID: 33131500 (View on PubMed)

Yan LD, Lookens Pierre J, Rouzier V, Theard M, Apollon A, St Preux S, Kingery JR, Jamerson KA, Deschamps M, Pape JW, Safford MM, McNairy ML. Comparing six cardiovascular risk prediction models in Haiti: implications for identifying high-risk individuals for primary prevention. BMC Public Health. 2022 Mar 19;22(1):549. doi: 10.1186/s12889-022-12963-x.

Reference Type: BACKGROUND

PMID: 35305599 (View on PubMed)

Smith CE, Metz M, Lookens Pierre J, Rouzier V, Yan LD, Sufra R, Dade E, Preval F, Ariste W, Rivera V, Tymejczyk O, Peck R, Koenig S, Deschamps MM, Pape W, McNairy ML. Comparison of community and clinic-based blood pressure measurements: A cross-sectional study from Haiti. PLOS Glob Public Health. 2022;2(9):e0001064. doi: 10.1371/journal.pgph.0001064. Epub 2022 Sep 30.

Reference Type: BACKGROUND

PMID: 36285251 (View on PubMed)

Yan LD, Devieux JG, Pierre JL, Dade E, Sufra R, St Preux S, Tymejczyk O, Nash D, Metz M, Lee MH, Fitzgerald DW, Deschamps M, Pape JW, McNairy ML, Rouzier V. The relationship between perceived stress and support with blood pressure in urban Haiti: A cross-sectional analysis. PLOS Glob Public Health. 2022;2(5):e0000263. doi: 10.1371/journal.pgph.0000263. Epub 2022 May 2.

Reference Type: BACKGROUND

PMID: 35785017 (View on PubMed)

Dade E, Metz M, Pierre JL, Rouzier V, Sufra R, Fox E, Preval F, St-Preux S, Zephir JR 2nd, Ariste W, Rasul R, Sabwa S, Roberts N, Deschamps MM, Severe P, Fitzgerald D, Pape JW, Yan LD, McNairy ML. High prevalence of obesity among women in urban Haiti: Findings from a population-based cohort. Front Public Health. 2022 Oct 5;10:976909. doi: 10.3389/fpubh.2022.976909. eCollection 2022.

Reference Type: BACKGROUND

PMID: 36276356 (View on PubMed)

Clermont A, Rouzier V, Pierre JL, Sufra R, Dade E, Preval F, St-Preux S, Deschamps MM, Apollon A, Dupnik K, Metz M, Duffus Y, Sabwa S, Yan LD, Lee MH, Palmer LG, Gerber LM, Pecker MS, Mann SJ, Safford MM, Fitzgerald DW, Pape JW, McNairy ML. High Dietary Sodium, Measured Using Spot Urine Samples, is Associated with Higher Blood Pressure among Young Adults in Haiti. Glob Heart. 2023 Feb 14;18(1):5. doi: 10.5334/gh.1187. eCollection 2023.

Reference Type: BACKGROUND

PMID: 36817226 (View on PubMed)

Kingery JR, Roberts NL, Lookens Pierre J, Sufra R, Dade E, Rouzier V, Malebranche R, Theard M, Goyal P, Pirmohamed A, Yan LD, Hee Lee M, Nash D, Metz M, Peck RN, Safford MM, Fitzgerald D, Deschamps MM, Pape JW, McNairy M. Population-Based Epidemiology of Heart Failure in a Low-Income Country: The Haiti Cardiovascular Disease Cohort. Circ Cardiovasc Qual Outcomes. 2023 Feb;16(2):e009093. doi: 10.1161/CIRCOUTCOMES.122.009093. Epub 2022 Dec 6.

Reference Type: BACKGROUND

PMID: 36472189 (View on PubMed)

Rasul R, Rouzier V, Sufra R, Yan LD, Joseph I, Mourra N, Sabwa S, Deschamps MM, Fitzgerald DW, Pape JW, Nash D, McNairy ML. Extreme Food Insecurity and Malnutrition in Haiti: Findings from a Population-Based Cohort in Port-au-Prince, Haiti. Nutrients. 2022 Nov 17;14(22):4854. doi: 10.3390/nu14224854.

Reference Type: BACKGROUND

PMID: 36432540 (View on PubMed)

Yan LD, McNairy ML, Devieux JG, Pierre JL, Dade E, Sufra R, Gerber LM, Roberts N, St Preux S, Malebranche R, Metz M, Tymejczyk O, Nash D, Deschamps M, Safford MM, Pape JW, Rouzier V. Neighborhood cohesion and violence in Port-au-Prince, Haiti, and their relationship to stress, depression, and hypertension: Findings from the Haiti cardiovascular disease cohort study. PLOS Glob Public Health. 2022;2(7):e0000503. doi: 10.1371/journal.pgph.0000503. Epub 2022 Jul 27.

Reference Type: BACKGROUND

PMID: 36819610 (View on PubMed)

Yan LD, Sufra R, St Sauveur R, Jean-Pierre MC, Apollon A, Malebranche R, Theard M, Pierre G, Devieux J, Lau J, Mourra N, Roberts NLS, Rasul R, Nash D, Pirmohamed AM, Devereux RB, Lee MH, Kwan GF, Safford MM, Adrien L, Alfred JP, Deschamps M, Severe P, Fitzgerald DW, Pape JW, Rouzier V, McNairy ML; Haiti Cardiovascular Disease Cohort study team. Spectrum of prevalent cardiovascular diseases in urban Port-au-Prince, Haiti: a population-based cross-sectional study. Lancet Reg Health Am. 2024 Apr 4;33:100729. doi: 10.1016/j.lana.2024.100729. eCollection 2024 May.

Reference Type: BACKGROUND

PMID: 38590326 (View on PubMed)

Roberts NLS, Pierre JL, Rouzier V, Sufra R, St-Preux S, Yan LD, Metz M, Clermont A, Apollon A, Sabwa S, Deschamps MM, Kingery JR, Peck R, Fitzgerald D, Pape JW, Tummalapalli SL, McNairy ML. Prevalence and Severity of Chronic Kidney Disease in Haiti. Clin J Am Soc Nephrol. 2023 Jun 1;18(6):739-747. doi: 10.2215/CJN.0000000000000175. Epub 2023 Apr 18.

Reference Type: BACKGROUND

PMID: 37081617 (View on PubMed)

Metz M, Sufra R, Ogyu A, Rouzier V, Sauveur RS, Celestin K, Forrestal G, Preval F, Jean M, Marcelin SE, Sarine A, Bennett C, Koenig S, Jamerson K, Pape JW, Yan LD, McNairy ML. Improvements in Blood Pressure Control and the Hypertension Care Continuum Over 2 Years in Urban Haiti Amidst Civil Unrest. J Clin Hypertens (Greenwich). 2025 Sep;27(9):e70153. doi: 10.1111/jch.70153.

Reference Type: DERIVED

PMID: 40991240 (View on PubMed)

Rasul R, Sufra R, Pierre MCJ, St Sauveur R, Rouzier V, Inddy J, Hilaire E, Preval F, Yan LD, Mourra N, Ogyu A, Pierre DM, Pape JW, Nash D, McNairy ML. Prevalence of Cooking with Polluting Fuels and Association with Elevated Blood Pressure Among Adults in Port au Prince, Haiti: A Cross-Sectional Analysis. Glob Heart. 2025 Feb 28;20(1):22. doi: 10.5334/gh.1405. eCollection 2025.

Reference Type: DERIVED

PMID: 40026345 (View on PubMed)

Sabwa S, Rouzier V, Sufra R, St Sauveur R, Mourra N, Rasul R, Inddy J, Yan LD, Sterling M, Pinheiro L, Deschamps M, Pape JW, McNairy ML. Cardiovascular Disease Multimorbidity and Decreased Health-Related Quality of Life in Haiti: A Cross-Sectional Study. J Am Heart Assoc. 2025 Feb 4;14(3):e036139. doi: 10.1161/JAHA.124.036139. Epub 2025 Jan 27.

Reference Type: DERIVED

PMID: 39868515 (View on PubMed)

Yan LD, Rouzier V, Pierre JL, Dade E, Sufra R, Huffman MD, Apollon A, St Preux S, Metz M, Sabwa S, Morisset B, Deschamps M, Pape JW, McNairy ML. Polypill for atherosclerotic cardiovascular disease prevention in Haiti: Eligibility estimates in a low-income country. Front Epidemiol. 2022;2:925464. doi: 10.3389/fepid.2022.925464. Epub 2022 Jul 14.

Reference Type: DERIVED

PMID: 36816341 (View on PubMed)

Other Identifiers

1803019037

Identifier Type: -

Identifier Source: org_study_id

R01HL143788

Identifier Type: NIH

Identifier Source: secondary_id

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