The SWEDEGRAFT Right-Heart-Substudy
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|ClinicalTrials.gov Identifier: NCT05049421|
Recruitment Status : Recruiting
First Posted : September 20, 2021
Last Update Posted : September 20, 2021
Right ventricular dysfunction is a common echocardiographic finding after cardiac surgery. Pericardial disruption has been suggested as the most probable cause as the phenomenon occurs within minutes after pericardial incision.
We suspect that validated two-dimensional echocardiographic measures for right ventricular function might not reflect the altered RV contraction pattern including paradoxical interventricular septal motion and reduced long-axis function following open cardiac surgery.
We aim to determine the prevalence and scale of right ventricular dysfunction two years after CABG by applying the latest available two- and three-dimensional echocardiographic technology in right ventricular evaluation. In addition, we investigate the impact of right ventricular dysfunction on functional outcome.
The Right-Heart-Study is an observational substudy of the SWEDEGRAFT trial at Aarhus University Hospital in Denmark. SWEDEGRAFT is a nordic, multicenter, prospective, randomized, register-based, clinical trial (ClinicalTrials.gov Identifier: NCT03501303; Ragnarsson 2020). Patients for the current Right-Heart-Substudy will be recruited amongst the 269 patients included in the SWEDEGRAFT trial at Aarhus University Hospital from 10 September 2018 to 25 May 2020. Patients are enrolled at the time of SWEDEGRAFT follow-up with cardiac-CT (approximately 30 months after CABG). After written informed consent, we perform additional full 2D and 3D echocardiography with special focus on RV function, collect patient-reported data on functional outcome, and measure brain natriuretic peptide and hemoglobin levels.
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Bypass Surgery Right-Sided Heart Failure||Diagnostic Test: Echocardiography||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Right Ventricular Function After Coronary Artery Bypass Grafting The SWEDEGRAFT Right-Heart-Substudy|
|Actual Study Start Date :||August 10, 2021|
|Estimated Primary Completion Date :||March 31, 2023|
|Estimated Study Completion Date :||March 31, 2023|
Patients following CABG
Recruitment amongst patients enrolled in SWEDEGRAFT RCT at Aarhus University Hospital scheduled for follow-up
Diagnostic Test: Echocardiography
Full 2D and 3D echocardiography with special focus on right ventricular function
- 3D right ventricular ejection fraction [ Time Frame: 30 months postoperative ]Right ventricular function assessed by 3D echocardiography
- Right ventricular strain [ Time Frame: 30 months postoperative ]Derived from two-dimensional speckle-tracking
- Disease-specific health-related quality of life [ Time Frame: 30 months postoperative ]Seattle Angina Questionnaire-7
- Degree of dyspnea at exertion [ Time Frame: 30 months postoperative ]NYHA class
- Perceived exertion during exercise [ Time Frame: 30 months postoperative ]Borg CR10® Scale
- Brain natriuretic peptide [ Time Frame: 30 months postoperative ]pg/mL
- Long-term Major Adverse Cardiac and Cerebrovascular Events [ Time Frame: 5 and 10 years after CABG ]all-cause mortality, myocardial infarction, repeat hospitalization due to cardiac cause, cerebrovascular accident, repeat revascularization
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05049421
|Contact: Ivy Modrau, MD, dr.med.||+45 firstname.lastname@example.org|
|Contact: Jesper Khedri Jensen, MD||+45 email@example.com|
|Principal Investigator:||Ivy Modrau, MD, dr.med.||Aarhus University Hospital Skejby|