Anticoagulant Adverse Reaction, Rheumatic Heart Disease
Conditions
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 .
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
PROCEDURECardiac surgery
Sponsors
Haukeland University Hospital
Addis Ababa University
Helse Nord-Trøndelag HF
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Short term outcome | 180 days | Freedom from Death or complication |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time in therapeutic INR | 2 years | Time in therapeutic window (anticoagulation) |
| Mitral valve area by Doppler | 14 days | Influence of concomitant pathology for Echocardiographic assessment of mitral stenosis |
| Mitral phenotype in rheumatic heart disease | 0 days | Influence of mitral valve phenotype with cardiac morphology and complications in untreated rheumatic heart disease patients |
Countries
Ethiopia, Norway
Contacts
Primary ContactHaavard Dalen, MD, PhD
Backup ContactRune Haaverstad, MD, PhD
Outcome results
None listed