Clinical trial NCT05049421: The SWEDEGRAFT Right-Heart-Substudy
Official title: Right Ventricular Function After Coronary Artery Bypass Grafting The SWEDEGRAFT Right-Heart-Substudy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Bypass Surgery
Right-Sided Heart Failure
Keywords: 2-D Echocardiography
3-D Echocardiography
Coronary Artery Bypass Surgery
Right-Sided Heart Failure
Patient Reported Outcome Measures
Lead sponsor: Aarhus University Hospital Skejby
Sponsor class: OTHER
Collaborators: name: Uppsala University
First posted: 2021-09-20
Enrollment: 207
Sex: ALL
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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

Eligibility 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

Primary outcomes:
measure: 3D right ventricular ejection fraction
timeFrame: 30 months postoperative
measure: Right ventricular strain
timeFrame: 30 months postoperative
Secondary outcomes:
measure: Disease-specific health-related quality of life
timeFrame: 30 months postoperative
measure: Degree of dyspnea at exertion
timeFrame: 30 months postoperative
measure: Perceived exertion during exercise
timeFrame: 30 months postoperative
measure: Pro-Brain Natriuretic Peptide
timeFrame: 30 months postoperative
measure: Long-term Major Adverse Cardiac and Cerebrovascular Events
timeFrame: 5 and 10 years after CABG
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital Skejby
Study officials:
affiliation: Aarhus University Hospital Skejby
name: Ivy Modrau, MD, dr.med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.