The SWEDEGRAFT Right-Heart-Substudy

Completed

• Conditions: Coronary Artery Bypass Surgery; Right-Sided Heart Failure
• Interventions: Diagnostic Test: Echocardiography

• Registration Number: NCT05049421
• Lead Sponsor: 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.

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.

Detailed Description

Complete study protocol attached

Study Timeline

• Study Start: 2021-08-10
• Study First Submitted: 2021-09-10
• Study First Submitted QC: 2021-09-10
• Study First Posted: 2021-09-20
• Primary Completion: 2022-10-31
• Study Completion: 2022-10-31
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-06
• Last Update Posted: 2023-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 207

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients following CABG	Echocardiography	Recruitment amongst patients enrolled in SWEDEGRAFT RCT at Aarhus University Hospital scheduled for follow-up

Primary Outcome Measures

Name	Time	Method
Right ventricular strain	30 months postoperative	Derived from two-dimensional speckle-tracking
3D right ventricular ejection fraction	30 months postoperative	Right ventricular function assessed by 3D echocardiography

Secondary Outcome Measures

Name	Time	Method
Perceived exertion during exercise	30 months postoperative	Borg CR10® Scale; -\> Range from 0: No exertion to 10: Maximal level of exertion
Degree of dyspnea at exertion	30 months postoperative	NYHA class
Long-term Major Adverse Cardiac and Cerebrovascular Events	5 and 10 years after CABG	all-cause mortality, myocardial infarction, repeat hospitalization due to cardiac cause, cerebrovascular accident, repeat revascularization
Disease-specific health-related quality of life	30 months postoperative	Seattle Angina Questionnaire-7; -\> 0 denotes the worst and 100 the best possible health status
Pro-Brain Natriuretic Peptide	30 months postoperative	pg/mL

Trial Locations

Locations (1)

Aarhus University Hospital Skejby; 🇩🇰 Aarhus, Denmark