The Clinical Influence of Developing a Sustainable Cardiac Surgery Service to Reduce the Burden of Rheumatic Heart Disease in Sub-Saharan Africa
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cardiac surgery.
- Who it may be relevant to
- Registry conditions: Rheumatic Heart Disease, Anticoagulant Adverse Reaction. Basic parameters: from 14 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Ethiopia, Norway
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
In this bi-directional program of education, training and research activities based on sustainable development goals aim is to develop cardiac surgery service in Ethiopia. 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 .
Detailed description
Our objectives are:
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)
Interventions
- Procedure Cardiac surgery
Primary outcome measures
- Short term outcome [Time frame: 180 days]
Eligibility criteria
Inclusion criteria
- Cardiac surgery due to rheumatic heart disease at the governmental Black Lion University Hospital during the bi-directional programme of education, training and Research to establish Cardiac surgery service
Exclusion criteria
- Not willing or able to provide written informed consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Norway · 3 centers
- Haukeland University Hospital — Bergen
- Oslo University Hospital — Oslo
- St. Olav University Hospital — Trondheim
Ethiopia · 1 center
- Black Lion University Hospital — Addis Ababa
Publications
- 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/op PMID 34376574
Identifiers
NCT: NCT04556188 · AISCaSS