- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02721030
Mbarara Acute Heart Failure Registry (MAHFER)
August 14, 2018 updated by: Samson Okello, Mbarara University of Science and Technology
Mbarara Acute Heart Failure Registry: Opportunities to Improve Care of Patients Hospitalized With Acute Decompensated Heart Failure in Mbarara Regional Referral Hospital, Uganda
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Actual)
217
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
-
-
N/A = Not Applicable
-
Mbarara, N/A = Not Applicable, Uganda, 0256
- Mbarara Regional Referral Hospital
-
-
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
13 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability 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.
Description
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 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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
All-cause mortality
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Length of hospitalization
Time Frame: 1 year
|
Length of hospital stay
|
1 year
|
Quality of life using the SF-36 questionnaire
Time Frame: 1 year
|
Quality of life will be measured using SF-36 questionnaire.
|
1 year
|
Functional status using the Kansas city cardiomyopathy questionnaire
Time Frame: 1 year
|
Kansas city cardiomyopathy questionnaire will be used to measure functional status during hospitalization and quarterly after hospitalization with acute heartfailure.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Charles Fardous, MMED, Mbarara University of Science & Technology
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.
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)
March 1, 2016
Primary Completion (Actual)
March 1, 2017
Study Completion (Actual)
March 23, 2018
Study Registration Dates
First Submitted
March 16, 2016
First Submitted That Met QC Criteria
March 25, 2016
First Posted (Estimate)
March 28, 2016
Study Record Updates
Last Update Posted (Actual)
August 15, 2018
Last Update Submitted That Met QC Criteria
August 14, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 26/11-14
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Not indicated
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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