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

Last updated: June 11, 2025
Sponsor: Helse Nord-Trøndelag HF
Overall Status: Active - Recruiting

Phase

N/A

Condition

Connective Tissue Diseases

Collagen Vascular Diseases

Heart Disease

Treatment

Cardiac surgery

Clinical Study ID

NCT04556188
AISCaSS
  • Ages > 14
  • All Genders

Study 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 .

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Cardiac surgery due to rheumatic heart disease at the governmental Black LionUniversity Hospital during the bi-directional programme of education, training andResearch to establish Cardiac surgery service

Exclusion

Exclusion Criteria:

  • Not willing or able to provide written informed consent

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: Cardiac surgery
Phase:
Study Start date:
March 01, 2016
Estimated Completion Date:
June 30, 2026

Study 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)

Connect with a study center

  • Black Lion University Hospital

    Addis Ababa,
    Ethiopia

    Active - Recruiting

  • Haukeland University Hospital

    Bergen,
    Norway

    Active - Recruiting

  • Oslo University Hospital

    Oslo,
    Norway

    Active - Recruiting

  • St. Olav University Hospital

    Trondheim, 7491
    Norway

    Active - Recruiting

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