The SWEDEGRAFT Right-Heart-Substudy

Right Ventricular Function After Coronary Artery Bypass Grafting 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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Bypass Surgery; Right-Sided Heart Failure
• Intervention / Treatment: Diagnostic test: Echocardiography

Detailed Description

Complete study protocol attached

• Study Type: Observational
• Enrollment (Actual): 207

Contacts and Locations

• Study Contact: Name: Jesper Khedri Jensen, MD; Phone Number: +45 60177420; Email: jesper.k.jensen@auh.rm.dk

Study Locations

• Denmark
  • Aarhus, Denmark, 8200
    • Aarhus University Hospital Skejby

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adult patients enrolled in the SWEDEGRAFT RCT due to 2,5 year follow-up. Patients have undergone elective stand-alone first-time coronary artery bypass grafting

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3D right ventricular ejection fraction	Right ventricular function assessed by 3D echocardiography	30 months postoperative
Right ventricular strain	Derived from two-dimensional speckle-tracking	30 months postoperative

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Aarhus University Hospital Skejby
• Collaborators: Uppsala University
• Investigators: Principal Investigator: Ivy Modrau, MD, dr.med., Aarhus University Hospital Skejby

Publications and helpful links

General Publications

• Ragnarsson S, Janiec M, Modrau IS, Dreifaldt M, Ericsson A, Holmgren A, Hultkvist H, Jeppsson A, Sartipy U, Ternstrom L, Per Vikholm MD, de Souza D, James S, Thelin S. No-touch saphenous vein grafts in coronary artery surgery (SWEDEGRAFT): Rationale and design of a multicenter, prospective, registry-based randomized clinical trial. Am Heart J. 2020 Jun;224:17-24. doi: 10.1016/j.ahj.2020.03.009. Epub 2020 Mar 13.

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2021
• Primary Completion (Actual): October 31, 2022
• Study Completion (Actual): October 31, 2022

Study Registration Dates

• First Submitted: September 10, 2021
• First Submitted That Met QC Criteria: September 10, 2021
• First Posted (Actual): September 20, 2021

Study Record Updates

• Last Update Posted (Actual): August 8, 2023
• Last Update Submitted That Met QC Criteria: August 6, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Patient Reported Outcome Measures; Coronary Artery Bypass Surgery; 2-D Echocardiography; Right-Sided Heart Failure; 3-D Echocardiography
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Heart Defects, Congenital; Cardiovascular Abnormalities; Situs Inversus; Heart Failure; Dextrocardia
• Other Study ID Numbers: 1-10-72-207-18-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No