An observational study in Hypertension, Diabetes and Obesity, sponsored by Washington University School of Medicine. Active, not recruiting at 1 site in Haiti. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Washington University School of Medicine · Observational
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.
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.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's enrollment of 3,005 is above the median of 350 across 1,163 observational studies indexed under Hypertension.
Browse Hypertension studies →Washington University School of Medicine is the lead sponsor of 1,803 studies on the registry; 271 are open to participants now.
Of its 329 completed or terminated interventional studies of FDA-regulated products, 216 (66%) have results posted.
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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.
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Exclusion Criteria:
No intervention is included in this observational study.
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.
Time frame: Baseline
Incidence of CVD risk factors and CVD during ~7 years of follow-up and their association with social and environmental determinants
Investigators will calculate the incidence rate of each CVD risk factor per 1000 person years (PY) of follow-up among participants without the respective CVD risk factor at baseline using a Horvitz-Thompson type estimator accounting for unequal sampling weights. Similarly, investigators will calculate the incidence rate of each CVD outcome among participants without the respective CVD at baseline.
Time frame: Participants will be followed for ~7 years
Plan to share: Yes — All the individual participant data collected during the trial, after deidentification will be shared.
Supporting information: Study protocol, Statistical analysis plan
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.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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