Rheumatic Heart DiseaseRHD-CaSSNCT04556188
The Clinical Influence of Developing a Sustainable Cardiac Surgery Service to Reduce the Burden of Rheumatic Heart Disease in Sub-Saharan Africa
An observational study of Rheumatic Heart Disease and Anticoagulant Adverse Reaction, run by Helse Nord-Trøndelag HF at 4 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Rheumatic Heart Disease, Anticoagulant Adverse Reaction
- What is being tested?
- Cardiac surgery
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 1 Mar 2016to 30 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Cases: Patients offered Cardiac surgery due to indication symptomatic rheumatic heart disease
Who may be able to join
- 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
Who cannot join
- Not willing or able to provide written informed consent
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
Norway3 sites, 3 recruiting
- Recruiting
Haukeland University Hospital
Bergen
Rune Haaverstad, MD, PhD, 55 97 22 20 ext. 0047, rune.haaverstad@sus.no
- Recruiting
Oslo University Hospital
Oslo
Mette E Estensen, MD, PhD, mee-2@online.no
- Recruiting
St. Olav University Hospital
Trondheim, 7491
Havard Dalen, MD, PhD, 06800 ext. 0047, havard.dalen@ntnu.no
Staale W Hauge, MD, staale.w.hauge@ntnu.no
Ethiopia1 site, 1 recruiting
- Recruiting
Black Lion University Hospital
Addis Ababa
Berhanu Nega, MD, 1911217472 ext. 0025, b_nega@yahoo.com
About this study
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 .
Read the detailed description
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)
- Being tested
- Cardiac surgery
- Medical subject headings
- Rheumatic Heart Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Cases | RHD patients undergoing Cardiac surgery at Addis Abeba University Hospital Receives: 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 being measured
The primary outcome is the main question the study is designed to answer.
Short term outcome
Freedom from Death or complication
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start1 Mar 2016
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatic Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helse Nord-Trøndelag HF
- Sponsor type
- University, hospital or other
- Collaborators
- Haukeland University Hospital, Addis Ababa University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04556188
- Sponsor's protocol ID
- AISCaSS
- Acronym
- RHD-CaSS
- Status last verified
- Jun 2025
- First submitted
- 17 Mar 2020
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: No written plan. Under discussion.
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.
PubMed 34376574
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Influence of Developing a Sustainable Cardiac Surgery Service to Reduce the Burden of Rheumatic Heart Disease in Sub-Saharan Africa
- ClinicalTrials.gov ID
- NCT04556188
- Acronym / sponsor ID
- RHD-CaSS / AISCaSS
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Helse Nord-Trøndelag HFUniversity, hospital or other
- Collaborators
- Haukeland University Hospital, Addis Ababa University
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 21 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Detailed description
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)
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Procedure: Cardiac surgeryRHD patients undergoing Cardiac surgery at Addis Abeba University Hospital |
| RHD controls | – | –RHD patients not offered Cardiac surgery |
| Anticoagulation controls | – | –Norwegian patients on anticoagulant therapy due to mechanical valve implants |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Cases: Patients offered Cardiac surgery due to indication symptomatic rheumatic heart disease
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Not willing or able to provide written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac surgery | Procedure or surgery | Cases |
Primary outcome
Short term outcome
Time frame: 180 days
Freedom from Death or complication
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Results publication: PubMed 34376574Hauge 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.
- Individual participant dataSharing planned: Undecided. No written plan. Under discussion.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatic Heart Disease and Anticoagulant Adverse Reaction, run by Helse Nord-Trøndelag HF at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Norway, Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haavard Dalen, MD, PhD (74098206 ext. 0047, havard.dalen@ntnu.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short term outcome (time frame: 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04556188, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.