NCT04556188

Brief 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 .

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
2mo left

Started Mar 2016

Longer than P75 for all trials

Geographic Reach
2 countries

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Mar 2016Jun 2026

Study Start

First participant enrolled

March 1, 2016

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

March 17, 2020

Completed
6 months until next milestone

First Posted

Study publicly available on registry

September 21, 2020

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

June 12, 2025

Status Verified

June 1, 2025

Enrollment Period

9.8 years

First QC Date

March 17, 2020

Last Update Submit

June 11, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Short term outcome

    Freedom from Death or complication

    180 days

Other Outcomes (3)

  • Time in therapeutic INR

    2 years

  • Mitral valve area by Doppler

    14 days

  • Mitral phenotype in rheumatic heart disease

    0 days

Study Arms (3)

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

Interventions

Cases

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Not willing or able to provide written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Black Lion University Hospital

Addis Ababa, Ethiopia

RECRUITING

Haukeland University Hospital

Bergen, Norway

RECRUITING

Oslo University Hospital

Oslo, Norway

RECRUITING

St. Olav University Hospital

Trondheim, 7491, Norway

RECRUITING

Related Publications (1)

  • 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.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Rheumatic Heart Disease

Interventions

Cardiac Surgical Procedures

Condition Hierarchy (Ancestors)

Rheumatic FeverStreptococcal InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical ProceduresSurgical Procedures, OperativeThoracic Surgical Procedures

Central Study Contacts

Haavard Dalen, MD, PhD

CONTACT

Rune Haaverstad, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2020

First Posted

September 21, 2020

Study Start

March 1, 2016

Primary Completion

December 31, 2025

Study Completion (Estimated)

June 30, 2026

Last Updated

June 12, 2025

Record last verified: 2025-06

Locations