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

Active, not recruiting

• Conditions: Kidney Diseases; Dyslipidemias; Cardiac Death; Diabetes; Obesity; Smoking; Physical Inactivity; Inflammation; Stroke; Hypertension

• Registration Number: NCT03892265
• Lead Sponsor: Weill Medical College of Cornell University

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.

Study Timeline

• Study Start: 2019-03-08
• Study First Submitted: 2019-03-25
• Study First Submitted QC: 2019-03-25
• Study First Posted: 2019-03-27
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-07
• Last Update Posted: 2025-03-11
• Primary Completion: 2028-08-01
• Study Completion: 2028-08-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 3005

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	Baseline	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.

Secondary Outcome Measures

Name	Time	Method
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	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.

Trial Locations

Locations (1)

Les Centres GHESKIO; 🇭🇹 Port-au-Prince, West, Haiti