Mbarara Acute Heart Failure Registry | NCT02721030

Studies
Mbarara Acute Heart Failure Registry

NCT02721030

Sponsor

Mbarara University of Science and Technology

Status

Completed

Last Update Posted

Aug 15, 2018Actual

Enrollment

217Actual

Phase

Not provided

Conditions

Heartfailure

Interventions

Not provided

Countries

Uganda

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2016Actual

Primary Completion Date

Mar 1, 2017Actual

Completion Date

Mar 23, 2018Actual

First Submitted Date

Mar 16, 2016

First Submission Date that Met QC Criteria

Mar 25, 2016

First Posted Date

Mar 28, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 14, 2018

Last Update Posted Date

Aug 15, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Samson Okello, Clinical Lecturer/Epidemiologist, Mbarara University of Science and TechnologyPrincipal Investigator

Lead Sponsor

Mbarara University of Science and TechnologyOTHER

Collaborators

Name	Class
University of Virginia	OTHER
Abbott Point of Care	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

This is a prospective observational cohort study to collect comprehensive data of heartfailure patients during and after hospitalization for acute heart failure at Mbarara Regional Referral Hospital (MRRH), Uganda. The investigators will collect sociodemographic, clinical, quality of life, functional status, and clinical cardiovascular disease measures during hospitalization and follow up for up to 1 year from the date of enrollment.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

217Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
All-cause mortality		1 year

Secondary Outcomes

Measure	Description	Time Frame
Length of hospitalization	Length of hospital stay	1 year
Quality of life using the SF-36 questionnaire	Quality of life will be measured using SF-36 questionnaire.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Charles Fardous, MMED	Mbarara University of Science & Technology	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mbarara Regional Referral Hospital		Mbarara	N/A = Not Applicable	0256	Uganda

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29655949	Result	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.