Actively Recruiting
Led by Helse Nord-Trøndelag HF · Updated on 2025-06-12
200
Participants Needed
4
Research Sites
25 weeks
Total Duration
H
Helse Nord-Trøndelag HF
Lead Sponsor
H
Haukeland University Hospital
Collaborating Sponsor
This research aims to evaluate cardiac surgery outcomes for people with rheumatic heart disease (RHD) in Ethiopia, a low-income country. It compares the short- and long-term results of those who receive surgery with individuals who do not, due to limited access to cardiac surgery services. The study also examines the quality of anticoagulant therapy after surgery, assessing complications and treatment effectiveness compared to patients in Norway. The study observes three groups: RHD patients undergoing cardiac surgery at Addis Abeba University Hospital, RHD patients who are not offered surgery, and Norwegian patients receiving anticoagulant therapy after valve replacement. Follow-up lasts 180 days for surgery outcomes, with ongoing monitoring of anticoagulation quality. Researchers look at mortality and complications such as heart failure, arrhythmias, thrombosis, bleeding, stroke, and infections. Participants will be monitored through clinical assessments and echocardiographic evaluations. The study tracks the time patients spend within therapeutic INR levels and records complications related to valve function and anticoagulant use. Outcome measures focus on short-term results at 180 days and longer-term anticoagulation quality. The study began in 2016 and will continue until 2026, involving matched control groups for comparison.
CONDITIONS
The Clinical Influence of Developing a Sustainable Cardiac Surgery Service to Reduce the Burden of Rheumatic Heart Disease in Sub-Saharan Africa
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to discharge from hospital
Participants undergo cardiac surgery for rheumatic heart disease followed by immediate post-operative care at the hospital.
Hospital stay visits as per routine care
Duration - 180 days
Participants are followed for 180 days after surgery to monitor outcomes including mortality and complications such as heart failure, arrhythmias, thrombosis, bleeding, stroke, and infections.
Regular follow-up visits up to 180 days
Duration - Ongoing beyond 180 days
Participants on anticoagulation therapy are continuously monitored for quality of therapy, including time in therapeutic INR-level and complications.
Visit frequency varies depending on anticoagulation management
Total: 4 locations
1
Black Lion University Hospital
Addis Ababa, Ethiopia
Actively Recruiting
2
Haukeland University Hospital
Bergen, Norway
Actively Recruiting
3
Oslo University Hospital
Oslo, Norway
Actively Recruiting
4
St. Olav University Hospital
Trondheim, Norway, 7491
Actively Recruiting
H
Haavard Dalen, MD, PhD
R
Rune Haaverstad, MD, PhD
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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Ståle Wågen Hauge, Havard Dalen, Mette E Estensen...
https://pubmed.ncbi.nlm.nih.gov/34376574