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NCT Number: NCT04556188

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

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 .

Recruiting

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Key information

Age range

14 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Black Lion University Hospital, Addis Ababa, Ethiopia

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About this study

Our objectives are:

  • 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.
  • 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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cardiac surgery

Procedure

Primary outcomes

  1. Short term outcome

    Time frame: 180 days

    Freedom from Death or complication

Other outcomes

  1. Time in therapeutic INR

    Time frame: 2 years

    Time in therapeutic window (anticoagulation)

  2. Mitral valve area by Doppler

    Time frame: 14 days

    Influence of concomitant pathology for Echocardiographic assessment of mitral stenosis

  3. Mitral phenotype in rheumatic heart disease

    Time frame: 0 days

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

Study contacts

Contact information is provided by the study sponsor or research team.

Haavard Dalen, MD, PhD

CONTACT

[email protected]

74098206 ext. 0047

Rune Haaverstad, MD, PhD

CONTACT

[email protected]

55 97 22 20 ext. 0047

Sponsors and collaborators

Lead sponsor

Helse Nord-Trøndelag HF

Other

Collaborators

  • Addis Ababa University
  • Haukeland University Hospital

Registry information

Acronym: RHD-CaSS

Important dates

Study start
2016
Primary completion
2025
Study completion
2026
First posted
Sep 21, 2020
Registry last updated
Jun 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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