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NCT06235424
Del Nido Versus HTK Cardioplegia in Adult Aortic Valve Replacement
Phase 4 trial testing Del Nido Cardioplegia Solution in Aortic Valve Disease in 100 participants. Status unknown.
24 April 2023
Quick facts
| Lead sponsor | Medical University of Gdansk |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 1 October 2018 |
| Primary completion | 24 April 2023 |
| Estimated completion | 24 September 2024 |
| Sites | 1 location across Poland |
Drugs / interventions tested
- Del Nido Cardioplegia Solution
- HTK solution
Conditions studied
- Aortic Valve Disease — all drugs for Aortic Valve Disease →
- Valve Disease, Heart — all drugs for Valve Disease, Heart →
- Cardiac Ischemia — all drugs for Cardiac Ischemia →
Sponsor
Medical University of Gdansk
Who can join
18 and older, any sex, with Aortic Valve Disease or Valve Disease, Heart. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this clinical trial is to compare del Nido and Bretschneider-HTK (HTK) cardioplegia solutions in patients undergoing elective aortic valve replacement. The main question it aims to answer is: • Does the del Nido cardioplegia provide better cardioprotection and clinical outcomes than HTK cardioplegia? Participants will receive one of the investigated cardioplegia solutions according to the randomization. Researchers will compare both groups in terms of cardioprotection (described as levels of CK-MB and hsTnI), in-hospital clinical outcomes, biochemical changes in coronary sinus blood and one-year follow-up.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06235424
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT06235424 (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 Medical University of Gdansk
- Last refreshed: 31 January 2024
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/NCT06235424.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing