NCT02721030

Brief Summary

This is a prospective cohort to describe clinical characteristics, predictors of poor outcomes both during hospitalization and at home, functional status, and quality of life among patients aged 13 years or more, consecutively admitted with acute decompensated heart failure at Mbarara Regional Referral Hospital.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
217

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 1, 2016

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

March 16, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 28, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2018

Completed
Last Updated

August 15, 2018

Status Verified

August 1, 2018

Enrollment Period

1 year

First QC Date

March 16, 2016

Last Update Submit

August 14, 2018

Conditions

Keywords

Heartfailure1-year mortalityheartfailure quality of lifesub-Saharan Africa

Outcome Measures

Primary Outcomes (1)

  • All-cause mortality

    1 year

Secondary Outcomes (3)

  • Length of hospitalization

    1 year

  • Quality of life using the SF-36 questionnaire

    1 year

  • Functional status using the Kansas city cardiomyopathy questionnaire

    1 year

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Target Population: Patients hospitalized in a medical ward of a resource poor setting. Accessible Population: Patients aged 13 years or more admitted with a diagnosis of acute decompensated Heart failure to the Medical ward of Mbarara Regional Referral Hospital.

You may qualify if:

  • Patients admitted with a confirmed clinical diagnosis of acute heartfailure aged 13 years or above at Mbarara Regional Referral Hospital, Uganda

You may not qualify if:

  • Body swelling from kidney disease, liver disease or malnutrition.
  • Acute kidney disease with no previous history/documentation of heart disease.
  • History suggestive of chronic kidney disease with no previous history/documentation of heart disease.
  • History suggestive of chronic liver disease with no previous history/documentation of heart disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mbarara Regional Referral Hospital

Mbarara, N/A = Not Applicable, 0256, Uganda

Location

Related Publications (1)

  • Abeya FC, Lumori BAE, Akello SJ, Annex BH, Buda AJ, Okello S. Incidence and predictors of 6 months mortality after an acute heart failure event in rural Uganda: The Mbarara Heart Failure Registry (MAHFER). Int J Cardiol. 2018 Aug 1;264:113-117. doi: 10.1016/j.ijcard.2018.03.110. Epub 2018 Mar 29.

Study Officials

  • Charles Fardous, MMED

    Mbarara University of Science & Technology

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Lecturer/Epidemiologist

Study Record Dates

First Submitted

March 16, 2016

First Posted

March 28, 2016

Study Start

March 1, 2016

Primary Completion

March 1, 2017

Study Completion

March 23, 2018

Last Updated

August 15, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Not indicated

Locations