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

NCT03892265 | Active Not Recruiting

• 2 other identifiers: 1803019037R01HL143788
• Study Type: observational
• Target: 3,005
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Prevalence of CVD risk factors and diseases and their association with social and environmental determinants in an established longitudinal cohort of ~3,000 Haitian adults

  The prevalence of CVD risk factors including HTN, diabetes, obesity, cigarette smoking, dyslipidemia, kidney disease, poor diet, physical inactivity, and inflammation will be calculated. Prevalence will be reported for categorical risk factors (e.g., HTN), and mean and standard deviation will be estimated for continuous risk factors (e.g., BP, lipid levels). The research team will also estimate the prevalence of each CVD outcome including MI, HF, and stroke.

  Baseline

Secondary Outcomes (1)

• Incidence of CVD risk factors and CVD during ~7 years of follow-up and their association with social and environmental determinants

  Participants will be followed for ~7 years

Interventions

Observational Study OTHER

No intervention is included in this observational study.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population will include 3,000 adults \>=18 years from a population-representative sample. Participants will be selected via multistage random sampling. Investigators will randomly select approximately 2,045 GPS waypoints across census blocks with the number of waypoints per block proportional to the IHSI estimated population size of each block. GPS waypoints will be randomly selected from satellite area maps, using ArcGIS software, and identified with GPS devices.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Weill Medical College of Cornell University: lead

Study Sites (1)

Les Centres GHESKIO

Port-au-Prince, West, Haiti

Location

Related Publications (19)

• 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.

  PMID: 35199944 BACKGROUND

• 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.

  PMID: 35282460 BACKGROUND

• 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.

  PMID: 35215437 BACKGROUND

• 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.

  PMID: 34878898 BACKGROUND

• 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.

  PMID: 33131500 BACKGROUND

• 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.

  PMID: 35305599 BACKGROUND

• 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.

  PMID: 36285251 BACKGROUND

• 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.

  PMID: 35785017 BACKGROUND

• 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.

  PMID: 36276356 BACKGROUND

• 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.

  PMID: 36817226 BACKGROUND

• 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.

  PMID: 36472189 BACKGROUND

• 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.

  PMID: 36432540 BACKGROUND

• 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.

  PMID: 36819610 BACKGROUND

• 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.

  PMID: 38590326 BACKGROUND

• 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.

  PMID: 37081617 BACKGROUND

• 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.

  PMID: 40991240 DERIVED

• 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.

  PMID: 40026345 DERIVED

• 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.

  PMID: 39868515 DERIVED

• 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.

  PMID: 36816341 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Biologic specimens include blood and urine specimens. A blood sample will be assessed for hematology, serum creatinine, glucose, cholesterol, and lipids (high-density lipoprotein and low-density lipoprotein), HIV-1, and finger prick lead level at the GHESKIO laboratory at baseline. Serum creatinine, glucose, cholesterol and lipids will be repeated at 24 months, and thereafter every 2 years. A urine sample will be assessed for a urine albumin to creatinine ratio (ACR) using urine supernatant samples at enrollment and 24 months, and every 2 years thereafter. Biobanked specimens (whole blood, plasma, urine, stool) will be collected on all participants at enrollment and at 24 months (blood only). At 48 and 72 months fasting blood and urine will be biobanked, along with stool at 72 months.

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus; Obesity; Kidney Diseases; Dyslipidemias; Smoking; Alcohol Drinking; Sedentary Behavior; Inflammation; Myocardial Infarction; Heart Failure; Stroke; Death

Interventions

Observation

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lipid Metabolism Disorders; Behavior; Drinking Behavior; Pathologic Processes; Myocardial Ischemia; Heart Diseases; Infarction; Ischemia; Necrosis; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Margaret McNairy, MD, MSc

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

• Jean W Pape, MD

  Weill Cornell Medical College /Les Centres GHESKIO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2019
• First Posted: March 27, 2019
• Study Start: March 8, 2019
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Study protocol and SAP available after publication and ending 3 years following publication.
• Access Criteria: Researchers who provide a methodologically sound proposal may have access. Proposals should be directed to the PI at mam9365@med.cornell.edu. To gain access, data requestors will need to sign a data access agreement. Data are available following publications through 3 years after publication and will be provided directly from the PI.

Locations

HA (1)