The Clinical Influence of Developing a Sustainable Cardiac Surgery Service to Reduce the Burden of Rheumatic Heart Disease in Sub-Saharan Africa
RHD-CaSS
1 other identifier
observational
200
2 countries
4
Brief Summary
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 .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2016
Longer than P75 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 17, 2020
CompletedFirst Posted
Study publicly available on registry
September 21, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
ExpectedJune 12, 2025
June 1, 2025
9.8 years
March 17, 2020
June 11, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Short term outcome
Freedom from Death or complication
180 days
Other Outcomes (3)
Time in therapeutic INR
2 years
Mitral valve area by Doppler
14 days
Mitral phenotype in rheumatic heart disease
0 days
Study Arms (3)
Cases
RHD patients undergoing Cardiac surgery at Addis Abeba University Hospital
RHD controls
RHD patients not offered Cardiac surgery
Anticoagulation controls
Norwegian patients on anticoagulant therapy due to mechanical valve implants
Interventions
Eligibility Criteria
Cases: Patients offered Cardiac surgery due to indication symptomatic rheumatic heart disease
You may qualify if:
- 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
You may not qualify if:
- Not willing or able to provide written informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Helse Nord-Trøndelag HFlead
- Haukeland University Hospitalcollaborator
- Addis Ababa Universitycollaborator
Study Sites (4)
Black Lion University Hospital
Addis Ababa, Ethiopia
Haukeland University Hospital
Bergen, Norway
Oslo University Hospital
Oslo, Norway
St. Olav University Hospital
Trondheim, 7491, Norway
Related Publications (1)
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.
PMID: 34376574RESULT
Biospecimen
Blood samples
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 17, 2020
First Posted
September 21, 2020
Study Start
March 1, 2016
Primary Completion
December 31, 2025
Study Completion (Estimated)
June 30, 2026
Last Updated
June 12, 2025
Record last verified: 2025-06