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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02721030
Other study ID # 26/11-14
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2016
Est. completion date March 23, 2018

Study information

Verified date August 2018
Source Mbarara University of Science and Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 217
Est. completion date March 23, 2018
Est. primary completion date March 1, 2017
Accepts healthy volunteers No
Gender All
Age group 13 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Uganda Mbarara Regional Referral Hospital Mbarara N/A = Not Applicable

Sponsors (3)

Lead Sponsor Collaborator
Mbarara University of Science and Technology Abbott Point of Care, University of Virginia

Country where clinical trial is conducted

Uganda, 

References & 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: 10.10 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary All-cause mortality 1 year
Secondary Length of hospitalization Length of hospital stay 1 year
Secondary Quality of life using the SF-36 questionnaire Quality of life will be measured using SF-36 questionnaire. 1 year
Secondary Functional status using the Kansas city cardiomyopathy questionnaire Kansas city cardiomyopathy questionnaire will be used to measure functional status during hospitalization and quarterly after hospitalization with acute heartfailure. 1 year
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