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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
Sponsor:
Collaborator:
Uppsala University
Information provided by (Responsible Party):
Ivy Modrau, Aarhus University Hospital Skejby

Brief Summary:

BACKGROUND

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.

METHODS

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 3D right ventricular ejection fraction [ Time Frame: 30 months postoperative ]
    Right ventricular function assessed by 3D echocardiography

  2. Right ventricular strain [ Time Frame: 30 months postoperative ]
    Derived from two-dimensional speckle-tracking


Secondary Outcome Measures :
  1. Disease-specific health-related quality of life [ Time Frame: 30 months postoperative ]
    Seattle Angina Questionnaire-7

  2. Degree of dyspnea at exertion [ Time Frame: 30 months postoperative ]
    NYHA class

  3. Perceived exertion during exercise [ Time Frame: 30 months postoperative ]
    Borg CR10® Scale

  4. Brain natriuretic peptide [ Time Frame: 30 months postoperative ]
    pg/mL

  5. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

SWEDEGRAFT inclusion criteria:

  • First-time non-emergent CABG patients
  • Need for at least one vein graft
  • Able to provide informed consent and accepted for isolated primary CABG.

Additional inclusion criteria for the Right-Heart-Substudy:

• Ability to meet for follow-up visit

Exclusion Criteria:

SWEDEGRAFT exclusion criteria:

  • No greater saphenous vein grafts available (previous vein stripping or poor vein quality)
  • Age > 80 years at the time of inclusion
  • Allergy to contrast dye
  • Renal failure with eGFR <15 ml/min at primary inclusion
  • Coagulation disorders
  • Excessive risk of wound infection
  • Participation in other interventional trial on grafts
  • Any condition that seriously increases the risk of non-compliance or loss of follow-up
  • Pregnant women or women of child bearing potential without negative pregnancy test

Additional inclusion criteria for the Right-Heart-Substudy:

• Inability to cooperate to transthoracic echocardiography


Information from the National Library of Medicine

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


Contacts
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Contact: Ivy Modrau, MD, dr.med. +45 24778856 ivymod@clin.au.dk
Contact: Jesper Khedri Jensen, MD +45 60177420 jesper.k.jensen@auh.rm.dk

Locations
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Denmark
Aarhus University Hospital Skejby Recruiting
Aarhus, Denmark, 8200
Contact: Ivy Modrau, MD, dr.med.    +45 24778856    ivymod@clin.au.dk   
Contact: Jesper Khedri Jensen, MD    +45 60177420    jesper.k.jensen@auh.rm.dk   
Sponsors and Collaborators
Aarhus University Hospital Skejby
Uppsala University
Investigators
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Principal Investigator: Ivy Modrau, MD, dr.med. Aarhus University Hospital Skejby
Publications:
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Responsible Party: Ivy Modrau, Consultant Cardiac Surgeon, Associate Professor, Aarhus University Hospital Skejby
ClinicalTrials.gov Identifier: NCT05049421    
Other Study ID Numbers: 1-10-72-207-18-2
First Posted: September 20, 2021    Key Record Dates
Last Update Posted: September 20, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ivy Modrau, Aarhus University Hospital Skejby:
2-D Echocardiography
3-D Echocardiography
Coronary Artery Bypass Surgery
Right-Sided Heart Failure
Patient Reported Outcome Measures
Additional relevant MeSH terms:
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Heart Failure
Dextrocardia
Heart Diseases
Cardiovascular Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities
Situs Inversus