The Clinical Influence of Developing a Sustainable Cardiac Surgery Service to Reduce the Burden of Rheumatic Heart Disease in Sub-Saharan Africa

Rheumatic Heart Disease Clinical Trial

— RHD-CaSS  

Official title:

The Clinical Influence of Developing a Sustainable Cardiac Surgery Service to Reduce the Burden of Rheumatic Heart Disease in Sub-Saharan Africa

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04556188
• Other study ID #: AISCaSS
• Status: Recruiting
• Start date: March 1, 2016
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2024
• Source: Helse Nord-Trøndelag HF
• Contact: Haavard Dalen, MD, PhD
• Phone: 74098206
• Email: havard.dalen[@]ntnu.no
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 .

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anticoagulant Adverse Reaction
• Heart Diseases
• Rheumatic Diseases
• Rheumatic Heart Disease

Intervention

Procedure:
• Cardiac surgery

Locations

Country	Name	City	State
Ethiopia	Black Lion University Hospital	Addis Ababa
Norway	Haukeland University Hospital	Bergen
Norway	Oslo University Hospital	Oslo
Norway	St. Olav University Hospital	Trondheim

Sponsors (3)

Lead Sponsor	Collaborator
Helse Nord-Trøndelag HF	Addis Ababa University, Haukeland University Hospital

Countries where clinical trial is conducted

Ethiopia,  Norway, 

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time in therapeutic INR	Time in therapeutic window (anticoagulation)	2 years
Other	Mitral valve area by Doppler	Influence of concomitant pathology for Echocardiographic assessment of mitral stenosis	14 days
Other	Mitral phenotype in rheumatic heart disease	Influence of mitral valve phenotype with cardiac morphology and complications in untreated rheumatic heart disease patients	0 days
Primary	Short term outcome	Freedom from Death or complication	180 days