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NCT Number: NCT05049421

The SWEDEGRAFT Right-Heart-Substudy

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.

The investigators 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.

The present study aims 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, the investigators 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.

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Key information

Age range

Up to 80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Aarhus University Hospital Skejby

Aarhus, 8200, Denmark

About this study

Complete study protocol attached

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Echocardiography

Diagnostic Test

Full 2D and 3D echocardiography with special focus on right ventricular function

Primary outcomes

  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 outcomes

  1. Disease-specific health-related quality of life

    Time frame: 30 months postoperative

    Seattle Angina Questionnaire-7

    -> 0 denotes the worst and 100 the best possible health status

  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

    -> Range from 0: No exertion to 10: Maximal level of exertion

  4. Pro-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

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital Skejby

Other

Collaborators

  • Uppsala University

Registry information

Official study title

Right Ventricular Function After Coronary Artery Bypass Grafting The SWEDEGRAFT Right-Heart-Substudy

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 20, 2021
Registry last updated
Aug 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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