HeartfailureMAHFERNCT02721030
Mbarara Acute Heart Failure Registry
An observational study of Heartfailure, run by Mbarara University of Science and Technology at 1 site in Uganda.
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. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Heartfailure
- How many people
- 217 participants
- Where
- 1 siteUganda
- Study dates
- 1 Mar 2016to 23 Mar 2018
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older 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.
Who may be able to join
- Patients admitted with a confirmed clinical diagnosis of acute heartfailure aged 13 years or above at Mbarara Regional Referral Hospital, Uganda
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Uganda1 site
Mbarara Regional Referral Hospital
Mbarara, N/A = Not Applicable, 0256
About this study
Official title: 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.
Read the 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.
- Conditions
- Heartfailure
- Keywords
- Heartfailure, 1-year mortality, heartfailure quality of life, sub-Saharan Africa
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Measured: 1 year
Secondary outcomes (3)
Length of hospitalization
Length of hospital stay
Measured: 1 year
Quality of life using the SF-36 questionnaire
Quality of life will be measured using SF-36 questionnaire.
Measured: 1 year
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2016 (estimated)
- Study start1 Mar 2016
- Primary completion1 Mar 2017
- Study completion23 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HeartfailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 217 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Mbarara University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- University of Virginia, Abbott Point of Care
- Responsible party
- Principal investigator, Samson Okello, Mbarara University of Science and Technology
- Investigators
- Charles Fardous, MMED, Study director, Mbarara University of Science & Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02721030
- Sponsor's protocol ID
- 26/11-14
- Acronym
- MAHFER
- Status last verified
- Aug 2018
- First submitted
- 16 Mar 2016
- Last updated
- 15 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Not indicated
Publications
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.
PubMed 29655949
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mbarara Acute Heart Failure Registry: Opportunities to Improve Care of Patients Hospitalized With Acute Decompensated Heart Failure in Mbarara Regional Referral Hospital, Uganda
- ClinicalTrials.gov ID
- NCT02721030
- Acronym / sponsor ID
- MAHFER / 26/11-14
- Conditions
- Heartfailure
- Keywords
- Heartfailure, 1-year mortality, heartfailure quality of life, sub-Saharan Africa
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- Mbarara University of Science and TechnologyUniversity, hospital or other
- Collaborators
- University of Virginia, Abbott Point of Care
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 1 Mar 2017 (actual)
- Study completion
- 23 Mar 2018 (actual)
- First posted
- 28 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older 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.
Key inclusion criteria (1 listed)
- Patients admitted with a confirmed clinical diagnosis of acute heartfailure aged 13 years or above at Mbarara Regional Referral Hospital, Uganda
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All-cause mortality
Time frame: 1 year
3 secondary outcomes
Length of hospitalization
Time frame: 1 year
Quality of life using the SF-36 questionnaire
Time frame: 1 year
Functional status using the Kansas city cardiomyopathy questionnaire
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2018.
- Results publication: PubMed 29655949Abeya 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.
- Individual participant dataSharing planned: No. Not indicated
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Fardous, MMED study director
Mbarara University of Science & Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heartfailure, run by Mbarara University of Science and Technology at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02721030, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2018.