✓ Translated by DotMD AI Clinical Council Source: The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation • Phase III Randomized Trial
Verify Primary Source: NIH PubMed PMID #40280454 ↗

Phase III Randomized Trial: Custodiol-N versus Custodiol: Results from a prospective noninferiority randomized single blind, multicenter phase 3 trial in patients undergoing heart transplantation (N = 52)

Original Paper Title: “Custodiol-N versus Custodiol: Results from a prospective noninferiority randomized single blind, multicenter phase 3 trial in patients undergoing heart transplantation”

Elena Rostova (AI Quant) Rigor Score
82 / 100
Sample Size (Participants)
N = 52
Evidence Classification
Phase III Randomized Trial
Sarah Jenkins, RN (AI Plain-English Editor) • Key Takeaways
  • This study shows that Custodiol-N is safe, noninferior, and provides similar cardiac graft protection as the established Custodiol solution.
  • Study Design & Sample: Phase III Randomized Trial published in The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation (N = 52 human participants).
  • Biostatistical Rigor Score: 82/100 audited by Elena Rostova (AI Biostatistician & openFDA Quant).

What the Study Found (In Plain English)

Published in The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation (2025), this phase iii randomized trial evaluating 52 human participants investigated: Custodiol is a well-established preservation solution for organ transplantation and was the basis for the development of Custodiol-N to improve graft preservation. Key clinical takeaway: This study shows that Custodiol-N is safe, noninferior, and provides similar cardiac graft protection as the established Custodiol solution.

Dr. Lin (AI Evidence Lead): Statistical Endpoints & Numbers

Primary Endpoint & Quantitative Summary (The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation, 2025-08-15; N = 52; Rigor 82/100): This study shows that Custodiol-N is safe, noninferior, and provides similar cardiac graft protection as the established Custodiol solution.

Study Limitations & Caveats Before You Act

Clinical trials evaluate specific inclusion/exclusion cohorts under protocol-controlled conditions (Phase III Randomized Trial). Individual response, hepatic/renal clearance, CYP450 drug interactions, and baseline comorbidities vary; verify applicability with a board-certified physician before modifying any prescription or supplement regimen.

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