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NCT05049421
The SWEDEGRAFT Right-Heart-Substudy
trial testing Echocardiography in Coronary Artery Bypass Surgery in 207 participants. Completed in 31 October 2022.
31 October 2022
Quick facts
| Lead sponsor | Aarhus University Hospital Skejby |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 207 |
| Start date | 10 August 2021 |
| Primary completion | 31 October 2022 |
| Estimated completion | 31 October 2022 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- Echocardiography
Conditions studied
- Coronary Artery Bypass Surgery — all drugs for Coronary Artery Bypass Surgery →
- Right-Sided Heart Failure — all drugs for Right-Sided Heart Failure →
Sponsor
Aarhus University Hospital Skejby
Who can join
Under 80, any sex, with Coronary Artery Bypass Surgery or Right-Sided Heart Failure. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05049421
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05049421 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Aarhus University Hospital Skejby
- Last refreshed: 8 August 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05049421.
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