The Malaria Heart Disease Study
Study Details
Study Description
Brief Summary
The Malaria Heart Disease Study is a prospective longitudinal cohort study of a random sample of approximately 1200 individuals from the state of Acre in Brazil. The overall hypothesis is that patients who have (i) previously suffered from a malaria infection or (ii) patients with ongoing symptomatic malaria will benefit from having an echocardiogram and blood tests performed as a screening tool to diagnose early cardiac impairment and prevent future cardiovascular disease.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
The purpose of this study is to investigate the relationship between exposure to malaria and the risk of developing subclinical and manifest cardiovascular disease. The study is conducted in the high endemic malaria zone pertaining to the city of Cruzeiro do Sul, located in the state of Acre, Brazil. The city is considered a part of the Amazon basin.
By invitation of a random sample of patients with a history of malaria, controls with no history of malaria, and symptomatic patients with ongoing malaria infection, the aim is to elucidate potential pathways linking malaria to cardiovascular disease.
Aim 1: Determine whether prior exposure to malaria is associated with myocardial dysfunction. The investigators hypothesize that adults with a history of treated malaria (cases) will have worse left ventricular (LV) diastolic function and systolic strain compared to age- and sex-matched controls without a history of malaria infection. The investigators will recruit 500 cases and 500 controls from Cruzeiro-do-Sul, Brazil. State-of-the-art ultrasonographic examinations will be used to asses novel imaging metrics of cardiac function.
Aim 2: Define the extent to which proinflammatory factors (such as Ang-2, CRP, VEGF) are associated with cardiac dysfunction in subjects with a history of malaria. The investigators hypothesize that proinflammatory biomarkers will be higher in cases compared to controls, and that higher concentrations of inflammatory markers will associate with worse LV diastolic function and strain. The investigators will measure inflammatory biomarkers, determine the association with cardiac dysfunction, and test whether history of malaria modifies this association.
Aim 3: Determine if echocardiographic parameters of systolic and diastolic function and cardiac biomarkers are significantly elevated in patients with symptomatic malaria (N=200).
Upon conclusion of this study, the investigators will better understand the relationship of malaria with subclinical cardiac dysfunction. This will allow development of the scientific foundation and necessary infrastructure to expand this project to a longitudinal study to prospectively assess associations with relevant clinical outcomes.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| History of malaria Individuals with a history of malaria infection |
Diagnostic Test: Assessment of cardiac function
Echocardiographic examination and assessment of cardiac biomakers
|
| Controls Individuals without a history of malaria infection |
Diagnostic Test: Assessment of cardiac function
Echocardiographic examination and assessment of cardiac biomakers
|
| Symptomatic malaria Patients with symptomatic malaria infection (complicated and uncomplicated) |
Diagnostic Test: Assessment of cardiac function
Echocardiographic examination and assessment of cardiac biomakers
|
Outcome Measures
Primary Outcome Measures
- Echocardiography [2020-2023]
Alterations in systolic and diastolic function assessed by conventional and speckle tracking echocardiography
- Biomarkers [2020-2023]
Elevated cardiac biomarkers
Secondary Outcome Measures
- Endothelial dysfunction [2020-2023]
Elevated markers of endothelial dysfunction
- Inflammation [2020-2023]
Elevated proinflammatory markers
Eligibility Criteria
Criteria
Group 1 (History of malaria) Inclusion: Patients with a record of malaria >=18 years old will be invited at random Exclusion: Persons not able to cooperate and persons unwilling or unable to understand and sign "informed consent", persons who are hospitalized due to severe malaria
Group 2 (Controls) Inclusion: Patients with no record of malaria >=18 years old will be invited at random Exclusion: Persons not able to cooperate and persons unwilling or unable to understand and sign "informed consent"
Group 3 (Symptomatic malaria) Inclusion: Patients >=18 years old diagnosed in outpatient/inpatient clinic with malaria infection by thick and thin blood smear and/or rapid diagnostic test. Enrollment of both severe (complicated) and uncomplicated malaria cases as defined by the WHO criteria. Exclusion: Persons not able to cooperate and persons unwilling or unable to understand and sign "informed consent", suspected or verified concomitant protozoal infections
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Philip Brainin | Cruzeiro do Sul | Acre | Brazil | 69980000 |
Sponsors and Collaborators
- University Hospital, Gentofte, Copenhagen
- Federal University of Acre
- University of Sao Paulo
- Independent Research Fund Denmark
Investigators
- Principal Investigator: Philip Brainin, MD, PhD, Federal University of Acre
- Principal Investigator: Odilson Silvestre, MD, PhD, MPH, Federal University of Acre
- Principal Investigator: Tor Biering-Sørensen, MD, PhD, MPH, Gentofte University Hospital
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 68999970512