The Clinical Influence of Developing a Sustainable Cardiac Surgery Service to Reduce the Burden of Rheumatic Heart Disease in Sub-Saharan Africa
NCT ID: NCT04556188
Last Updated: 2025-06-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2016-03-01
2026-06-30
Brief Summary
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The aim is to evaluate the short and long-term outcome of cardiac surgery for rheumatic heart disease in a low-income country compared to individuals not offered cardiac surgery due to limited availability of the service. Second aim is to evaluate the quality of anticoagulant therapy in patients after cardiac surgery for rheumatic heart disease in a low-income country .
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Detailed Description
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1. To evaluate the 30- and 180-days outcome of cardiac surgery for rheumatic heart disease (RHD), and impact of gender, age, clinical findings and echocardiographic classification, during the time of development of cardiac surgery at Black Lion hospital, Ethiopia, in comparison with matched individuals (from the same waiting list) which had no offer of surgery due to limited availability.
2. To evaluate the quality of anticoagulation therapy after cardiac surgery at Black Lion hospital, Ethiopia by evaluating the patients proportion of time in therapeutic INR-level, complications as valve dysfunction, bleeding and thrombosis compared to control patients undergoing valvular replacement due to RHD at Norwegian hospitals.
Population: Approximately 50 RHD patients operated by Our team at Addis Abeba University Hospital, Ethiopia.
Follow up for 180-days for objective 1 and continous follow-up for objective 2. Comparison With matched Controls. Outcome measures: Mortality, complications (heart failure, arrhythmias, thrombosis, bleedings, stroke, infections)
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Cases
RHD patients undergoing Cardiac surgery at Addis Abeba University Hospital
Cardiac surgery
RHD controls
RHD patients not offered Cardiac surgery
No interventions assigned to this group
Anticoagulation controls
Norwegian patients on anticoagulant therapy due to mechanical valve implants
No interventions assigned to this group
Interventions
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Cardiac surgery
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
14 Years
ALL
No
Sponsors
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Haukeland University Hospital
OTHER
Addis Ababa University
OTHER
Helse Nord-Trøndelag HF
OTHER
Responsible Party
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Locations
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Black Lion University Hospital
Addis Ababa, , Ethiopia
Haukeland University Hospital
Bergen, , Norway
Oslo University Hospital
Oslo, , Norway
St. Olav University Hospital
Trondheim, , Norway
Countries
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Central Contacts
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Facility Contacts
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References
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Hauge SW, Dalen H, Estensen ME, Persson RM, Abebe S, Mekonnen D, Nega B, Solholm A, Farstad M, Bogale N, Graven T, Nielssen NE, Brekke HK, Vikenes K, Haaverstad R. Short-term outcome after open-heart surgery for severe chronic rheumatic heart disease in a low-income country, with comparison with an historical control group: an observational study. Open Heart. 2021 Aug;8(2):e001706. doi: 10.1136/openhrt-2021-001706.
Other Identifiers
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AISCaSS
Identifier Type: -
Identifier Source: org_study_id
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