The SWEDEGRAFT Right-Heart-Substudy

Aarhus University Hospital Skejby

Status: Completed

Conditions: Right-Sided Heart Failure; Coronary Artery Bypass Surgery

Treatments: Diagnostic Test: Echocardiography

Study type: Observational

Funder types: Other

Identifiers

NCT05049421

1-10-72-207-18-2

Details and patient eligibility

About

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.

Full description

Complete study protocol attached

Enrollment: 207 patients

Sex: All

Ages: Under 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

207 participants in 1 patient group

Patients following CABG

Description:

Recruitment amongst patients enrolled in SWEDEGRAFT RCT at Aarhus University Hospital scheduled for follow-up

Treatment:

Diagnostic Test: Echocardiography