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

Sponsor
Helse Nord-Trøndelag HF (Other)
Overall Status
Recruiting
CT.gov ID
NCT04556188
Collaborator
Haukeland University Hospital (Other), Addis Ababa University (Other)
200
4
106
50
0.5

Study Details

Study Description

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 .

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
The Clinical Influence of Developing a Sustainable Cardiac Surgery Service to Reduce the Burden of Rheumatic Heart Disease in Sub-Saharan Africa
Actual Study Start Date :
Mar 1, 2016
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Short term outcome [180 days]

    Freedom from Death or complication

Other Outcome Measures

  1. Time in therapeutic INR [2 years]

    Time in therapeutic window (anticoagulation)

  2. Mitral valve area by Doppler [14 days]

    Influence of concomitant pathology for Echocardiographic assessment of mitral stenosis

  3. Mitral phenotype in rheumatic heart disease [0 days]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
14 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Black Lion University Hospital Addis Ababa Ethiopia
2 Haukeland University Hospital Bergen Norway
3 Oslo University Hospital Oslo Norway
4 St. Olav University Hospital Trondheim Norway 7491

Sponsors and Collaborators

  • Helse Nord-Trøndelag HF
  • Haukeland University Hospital
  • Addis Ababa University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Helse Nord-Trøndelag HF
ClinicalTrials.gov Identifier:
NCT04556188
Other Study ID Numbers:
  • AISCaSS
First Posted:
Sep 21, 2020
Last Update Posted:
Apr 14, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 14, 2022