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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age14+
SponsorHelse Nord-Trøndelag HF

About this trial

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 .

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Not willing or able to provide written informed consent

Trial population

Cases: Patients offered Cardiac surgery due to indication symptomatic rheumatic heart disease

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Cardiac surgery

    Procedure/Surgery

Treatment groups

200 Participants
are divided into 3 treatment groups
Group A: Cases1 intervention
Group B: RHD controls0 interventions
Group C: Anticoagulation controls0 interventions

Trial outcomes

Primary outcomes

1

Short term outcome

Freedom from Death or complication

Time frame
180 days

Secondary outcomes

Other outcomes

1

Time in therapeutic INR

Time in therapeutic window (anticoagulation)

Time frame
2 years
2

Mitral valve area by Doppler

Influence of concomitant pathology for Echocardiographic assessment of mitral stenosis

Time frame
14 days
3

Mitral phenotype in rheumatic heart disease

Influence of mitral valve phenotype with cardiac morphology and complications in untreated rheumatic heart disease patients

Time frame
0 days

Sponsors and contacts

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Helse Nord-Trøndelag HF

Lead sponsor

Haukeland University Hospital

Collaborator

Addis Ababa University

Collaborator