NCT Number: NCT04556188
The Clinical Influence of Developing a Sustainable Cardiac Surgery Service to Reduce the Burden of Rheumatic Heart Disease in Sub-Saharan Africa
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 .
Interested in participating?
Request InfoKey information
Conditions
Age range
14 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Black Lion University Hospital, Addis Ababa, Ethiopia
About this study
Our objectives are:
- 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.
- 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)
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Short term outcome
Time frame: 180 days
Freedom from Death or complication
Other outcomes
-
Time in therapeutic INR
Time frame: 2 years
Time in therapeutic window (anticoagulation)
-
Mitral valve area by Doppler
Time frame: 14 days
Influence of concomitant pathology for Echocardiographic assessment of mitral stenosis
-
Mitral phenotype in rheumatic heart disease
Time frame: 0 days
Influence of mitral valve phenotype with cardiac morphology and complications in untreated rheumatic heart disease patients
Study contacts
Contact information is provided by the study sponsor or research team.
Haavard Dalen, MD, PhD
CONTACT
74098206 ext. 0047
Rune Haaverstad, MD, PhD
CONTACT
55 97 22 20 ext. 0047
Sponsors and collaborators
Lead sponsor
Helse Nord-Trøndelag HF
Other
Collaborators
- Addis Ababa University
- Haukeland University Hospital
Registry information
Acronym: RHD-CaSS
Important dates
- Study start
- 2016
- Primary completion
- 2025
- Study completion
- 2026
- First posted
- Sep 21, 2020
- Registry last updated
- Jun 12, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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