NCT04445103

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
597

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

June 21, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 24, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2021

Completed
Last Updated

July 19, 2022

Status Verified

July 1, 2022

Enrollment Period

7 months

First QC Date

June 21, 2020

Last Update Submit

July 16, 2022

Conditions

Plasmodium FalciparumPlasmodium VivaxHeart DiseasesCardiovascular Diseases

Keywords

EchocardiographyEndothelial dysfunctionCardiovascular inflammation

Outcome Measures

Primary Outcomes (2)

  • Echocardiography

    Alterations in systolic and diastolic function assessed by conventional and speckle tracking echocardiography

    2020-2023

  • Biomarkers

    Elevated cardiac biomarkers

    2020-2023

Secondary Outcomes (2)

  • Endothelial dysfunction

    2020-2023

  • Inflammation

    2020-2023

Study Arms (3)

History of malaria

Individuals with a history of malaria infection

Diagnostic Test: Assessment of cardiac function

Controls

Individuals without a history of malaria infection

Diagnostic Test: Assessment of cardiac function

Symptomatic malaria

Patients with symptomatic malaria infection (complicated and uncomplicated)

Diagnostic Test: Assessment of cardiac function

Interventions

Assessment of cardiac functionDIAGNOSTIC_TEST

Echocardiographic examination and assessment of cardiac biomakers

ControlsHistory of malariaSymptomatic malaria

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Philip Brainin

Cruzeiro do Sul, Acre, 69980000, Brazil

Location

Related Publications (7)

  • Wegener A, Lima KO, Holm AE, Gomes LC, Matos LO, Vieira IVM, Souza RM, Marinho CRF, Vestergaard LS, Biering-Sorensen T, Silvestre OM, Brainin P. Cardiopulmonary alterations by ultrasound in a patient with uncomplicated mixed malaria infection: a case report from the Amazon Basin. Malar J. 2021 Jul 28;20(1):330. doi: 10.1186/s12936-021-03861-5.

    PMID: 34321001RESULT

  • Holm AE, Gomes LC, Lima KO, Wegener A, Matos LO, Vieira IVM, Kaagaard MD, Pareek M, de Souza RM, Marinho CRF, Biering-Sorensen T, Silvestre OM, Brainin P. Tropical diseases and risk of hypertension in the Amazon Basin: a cross-sectional study. J Hum Hypertens. 2022 Dec;36(12):1121-1127. doi: 10.1038/s41371-021-00633-1. Epub 2021 Nov 13.

    PMID: 34775497RESULT

  • Wegener A, Kaagaard MD, Gomes LC, Holm AE, Matos LO, Lima KO, Vieira IVM, de Souza RM, Olsen FJ, Marinho CRF, Biering-Sorensen T, Silvestre OM, Brainin P. Reference values for left ventricular dimensions, systolic and diastolic function: a study from the Amazon Basin of Brazil. Int J Cardiovasc Imaging. 2022 Apr;38(4):813-822. doi: 10.1007/s10554-021-02475-x. Epub 2021 Nov 22.

    PMID: 34807316RESULT

  • 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-Sorensen T, Silvestre OM, Brainin P. Frequency of Electrocardiographic Alterations and Pericardial Effusion in Patients With Uncomplicated Malaria. Am J Cardiol. 2022 Feb 15;165:116-123. doi: 10.1016/j.amjcard.2021.11.009. Epub 2021 Dec 12.

    PMID: 34906368RESULT

  • Wegener A, Holm AE, Gomes LC, Lima KO, Kaagaard MD, Matos LO, Vieira IVM, de Souza RM, Marinho CRF, Nascimento BR, Biering-Sorensen T, Silvestre OM, Brainin P. Prevalence of rheumatic heart disease in adults from the Brazilian Amazon Basin. Int J Cardiol. 2022 Apr 1;352:115-122. doi: 10.1016/j.ijcard.2022.01.026. Epub 2022 Jan 20.

    PMID: 35065154RESULT

  • Wegener A, Holm AE, Gomes LC, Lima KO, Matos LO, Vieira IVM, Kaagaard MD, de Souza RM, Hviid L, Guimaraes Lacerda MV, Vestergaard LS, Farias Marinho CR, Platz E, Biering-Sorensen T, Silvestre OM, Brainin P. Prevalence and Dynamic Changes in Lung Ultrasound Findings among Adults with Uncomplicated Malaria and Controls in the Amazon Basin, Brazil. Am J Trop Med Hyg. 2022 Apr 11;106(6):1637-45. doi: 10.4269/ajtmh.21-1107. Online ahead of print.

    PMID: 35405640RESULT

  • Holm AE, Gomes LC, Wegener A, Lima KO, Matos LO, Vieira IVM, Kaagaard MD, Pareek M, de Souza RM, Marinho CRF, Biering-Sorensen T, Silvestre OM, Brainin P. Is self-rated health associated with cardiovascular risk factors and disease in a low-income setting? A cross-sectional study from the Amazon Basin of Brazil. BMJ Open. 2022 Aug 30;12(8):e058277. doi: 10.1136/bmjopen-2021-058277.

    PMID: 36041756DERIVED

MeSH Terms

Conditions

Malaria, FalciparumMalaria, VivaxHeart DiseasesCardiovascular Diseases

Condition Hierarchy (Ancestors)

MalariaProtozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Philip Brainin, MD, PhD

Study Record Dates

First Submitted

June 21, 2020

First Posted

June 24, 2020

Study Start

June 21, 2020

Primary Completion

January 25, 2021

Study Completion

January 25, 2021

Last Updated

July 19, 2022

Record last verified: 2022-07

Locations

BR(1)