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

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 .

Study Overview

• Status: Recruiting
• Conditions: Rheumatic Heart Disease; Anticoagulant Adverse Reaction
• Intervention / Treatment: Procedure: Cardiac surgery

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 Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Haavard Dalen, MD, PhD; Phone Number: 0047 74098206; Email: havard.dalen@ntnu.no
• Study Contact Backup: Name: Rune Haaverstad, MD, PhD; Phone Number: 0047 55 97 22 20; Email: rune.haaverstad@helse-bergen.no

Study Locations

• Ethiopia
  • Addis Ababa, Ethiopia
    • Recruiting
    • Black Lion University Hospital
    • Contact: Berhanu Nega, MD; Phone Number: 0025 1911217472; Email: b_nega@yahoo.com
• Norway
  • Bergen, Norway
    • Recruiting
    • Haukeland University Hospital
    • Contact: Rune Haaverstad, MD, PhD; Phone Number: 0047 55 97 22 20; Email: rune.haaverstad@sus.no
  • Oslo, Norway
    • Recruiting
    • Oslo University Hospital
    • Contact: Mette E Estensen, MD, PhD; Email: mee-2@online.no
  • Trondheim, Norway, 7491
    • Recruiting
    • St. Olav University Hospital
    • Contact: Havard Dalen, MD, PhD; Phone Number: 0047 06800; Email: havard.dalen@ntnu.no
    • Contact: Staale W Hauge, MD; Email: staale.w.hauge@ntnu.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cases; RHD patients undergoing Cardiac surgery at Addis Abeba University Hospital	Procedure: Cardiac surgery
RHD controls; RHD patients not offered Cardiac surgery
Anticoagulation controls; Norwegian patients on anticoagulant therapy due to mechanical valve implants

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short term outcome	Freedom from Death or complication	180 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time in therapeutic INR	Time in therapeutic window (anticoagulation)	2 years
Mitral valve area by Doppler	Influence of concomitant pathology for Echocardiographic assessment of mitral stenosis	14 days
Mitral phenotype in rheumatic heart disease	Influence of mitral valve phenotype with cardiac morphology and complications in untreated rheumatic heart disease patients	0 days

Collaborators and Investigators

• Sponsor: Helse Nord-Trøndelag HF
• Collaborators: Haukeland University Hospital; Addis Ababa University

Publications and helpful links

General Publications

• 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 low-income country, with comparison with an historical control group: an observational study. Open Heart. 2021 Aug;8(2):e001706. doi: 10.1136/openhrt-2021-001706.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: March 17, 2020
• First Submitted That Met QC Criteria: September 15, 2020
• First Posted (Actual): September 21, 2020

Study Record Updates

• Last Update Posted (Actual): June 12, 2025
• Last Update Submitted That Met QC Criteria: June 11, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Cardiovascular Diseases; Connective Tissue Diseases; Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Rheumatic Fever; Heart Diseases; Rheumatic Diseases; Rheumatic Heart Disease
• Other Study ID Numbers: AISCaSS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: No written plan. Under discussion.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No