The Malaria Heart Disease Study

July 16, 2022 updated by: Philip Brainin, University Hospital, Gentofte, Copenhagen

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

597

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Acre
      • Cruzeiro do Sul, Acre, Brazil, 69980000
        • Philip Brainin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study population conforms to three study groups: i) History of malaria infection ii) Controls and iii) Symptomatic malaria infection

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Echocardiography
Time Frame: 2020-2023
Alterations in systolic and diastolic function assessed by conventional and speckle tracking echocardiography
2020-2023
Biomarkers
Time Frame: 2020-2023
Elevated cardiac biomarkers
2020-2023

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endothelial dysfunction
Time Frame: 2020-2023
Elevated markers of endothelial dysfunction
2020-2023
Inflammation
Time Frame: 2020-2023
Elevated proinflammatory markers
2020-2023

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Gentofte, Copenhagen

Collaborators

University of Sao Paulo
Independent Research Fund Denmark
Federal University of Acre

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 21, 2020

Primary Completion (Actual)

January 25, 2021

Study Completion (Actual)

January 25, 2021

Study Registration Dates

First Submitted

June 21, 2020

First Submitted That Met QC Criteria

June 21, 2020

First Posted (Actual)

June 24, 2020

Study Record Updates

Last Update Posted (Actual)

July 19, 2022

Last Update Submitted That Met QC Criteria

July 16, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 68999970512

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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