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

Recruiting

• Conditions: Rheumatic Heart Disease; Anticoagulant Adverse Reaction
• Interventions: Procedure: Cardiac surgery

• Registration Number: NCT04556188
• Lead Sponsor: Helse Nord-Trøndelag HF

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)

Study Timeline

• Study Start: 2016-03-01
• Study First Submitted: 2020-03-17
• Study First Submitted QC: 2020-09-15
• Study First Posted: 2020-09-21
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-03
• Last Update Posted: 2024-06-04
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cases	Cardiac surgery	RHD patients undergoing Cardiac surgery at Addis Abeba University Hospital

Primary Outcome Measures

Name	Time	Method
Short term outcome	180 days	Freedom from Death or complication

Trial Locations

Locations (4)

Black Lion University Hospital; 🇪🇹 Addis Ababa, Ethiopia

Oslo University Hospital; 🇳🇴 Oslo, Norway

St. Olav University Hospital; 🇳🇴 Trondheim, Norway

Haukeland University Hospital; 🇳🇴 Bergen, Norway