The Malaria Heart Disease Study

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04445103
• Other study ID #: 68999970512
• Status: Terminated
• Start date: June 21, 2020
• Est. completion date: January 25, 2021

Study information

• Verified date: July 2022
• Source: University Hospital, Gentofte, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 597
• Est. completion date: January 25, 2021
• Est. primary completion date: January 25, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Heart Diseases
• Malaria
• Plasmodium Falciparum
• Plasmodium Vivax

Intervention

Diagnostic Test:
• Assessment of cardiac function
Echocardiographic examination and assessment of cardiac biomakers

Locations

Country	Name	City	State
Brazil	Philip Brainin	Cruzeiro do Sul	Acre

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Gentofte, Copenhagen	Federal University of Acre, Independent Research Fund Denmark, University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (6)

Holm AE, Gomes LC, Lima KO, Wegener A, Matos LO, Vieira IVM, Kaagaard MD, Pareek M, de Souza RM, Marinho CRF, Biering-Sørensen T, Silvestre OM, Brainin P. Tropical diseases and risk of hypertension in the Amazon Basin: a cross-sectional study. J Hum Hyper — View Citation

Kaagaard MD, Matos LO, Holm AE, Gomes LC, Wegener A, Lima KO, Vieira IVM, de Souza RM, Marinho CRF, Hviid L, Vestergaard LS, Dominguez H, Biering-Sørensen T, Silvestre OM, Brainin P. Frequency of Electrocardiographic Alterations and Pericardial Effusion i — View Citation

Wegener A, Holm AE, Gomes LC, Lima KO, Kaagaard MD, Matos LO, Vieira IVM, de Souza RM, Marinho CRF, Nascimento BR, Biering-Sørensen T, Silvestre OM, Brainin P. Prevalence of rheumatic heart disease in adults from the Brazilian Amazon Basin. Int J Cardiol. — View Citation

Wegener A, Holm AE, Gomes LC, Lima KO, Matos LO, Vieira IVM, Kaagaard MD, de Souza RM, Hviid L, Guimarães Lacerda MV, Vestergaard LS, Farias Marinho CR, Platz E, Biering-Sørensen T, Silvestre OM, Brainin P. Prevalence and Dynamic Changes in Lung Ultrasoun — View Citation

Wegener A, Kaagaard MD, Gomes LC, Holm AE, Matos LO, Lima KO, Vieira IVM, de Souza RM, Olsen FJ, Marinho CRF, Biering-Sørensen T, Silvestre OM, Brainin P. Reference values for left ventricular dimensions, systolic and diastolic function: a study from the — View Citation

Wegener A, Lima KO, Holm AE, Gomes LC, Matos LO, Vieira IVM, Souza RM, Marinho CRF, Vestergaard LS, Biering-Sørensen T, Silvestre OM, Brainin P. Cardiopulmonary alterations by ultrasound in a patient with uncomplicated mixed malaria infection: a case repo — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Echocardiography	Alterations in systolic and diastolic function assessed by conventional and speckle tracking echocardiography	2020-2023
Primary	Biomarkers	Elevated cardiac biomarkers	2020-2023
Secondary	Endothelial dysfunction	Elevated markers of endothelial dysfunction	2020-2023
Secondary	Inflammation	Elevated proinflammatory markers	2020-2023

External Links

•   Official study website