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The Malaria Heart Disease Study

The Malaria Heart Disease Study: A Novel Pathway to Subclinical Heart Disease

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04445103
Enrollment
597
Registered
2020-06-24
Start date
2020-06-21
Completion date
2021-01-25
Last updated
2022-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Heart Diseases, Plasmodium Falciparum, Plasmodium Vivax

Keywords

Echocardiography, Endothelial dysfunction, Cardiovascular inflammation

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.

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.

Interventions

DIAGNOSTIC_TESTAssessment of cardiac function

Echocardiographic examination and assessment of cardiac biomakers

Sponsors

Federal University of Acre
CollaboratorUNKNOWN
University of Sao Paulo
CollaboratorOTHER
Independent Research Fund Denmark
CollaboratorINDUSTRY
University Hospital, Gentofte, Copenhagen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Echocardiography2020-2023Alterations in systolic and diastolic function assessed by conventional and speckle tracking echocardiography
Biomarkers2020-2023Elevated cardiac biomarkers

Secondary

MeasureTime frameDescription
Endothelial dysfunction2020-2023Elevated markers of endothelial dysfunction
Inflammation2020-2023Elevated proinflammatory markers

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026