Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2025-12-25 @ 4:57 PM
Study NCT ID:
NCT04445103
Status:
TERMINATED
Last Update Posted:
2022-07-19
First Post:
2020-06-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Malaria Heart Disease Study
Sponsor:
University Hospital, Gentofte, Copenhagen
Organization:
Study Overview
Official Title:
The Malaria Heart Disease Study: A Novel Pathway to Subclinical Heart Disease
Status:
TERMINATED
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to the COVID-19 pandemic it was not possible to complete the study inclusion as originally anticipated.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: