Treatment With 5-AminoLEvuliNic Acid Before Cardiac Surgery (NCT07027670) | Clinical Trial Compass
CompletedPhase 2
Treatment With 5-AminoLEvuliNic Acid Before Cardiac Surgery
United Kingdom48 participantsStarted 2021-02-01
Plain-language summary
TALEN is a prospective randomised double-blind placebo-controlled phase 2 study of 5-Aminolevulinic Acid with Sodium Ferrous Citrate (5-ALA-SFC) in adult patients undergoing cardiac surgery on cardiopulmonary bypass (CPB). TALEN aims to identify the optimal biological dose (OBD) of 5-ALA-SFC.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Scheduled for non-emergent cardiac surgery under CPB (including coronary artery bypass grafting, valve replacement, valve repair or a combination thereof)
* Signed informed consent
* Age ≥18 years
* Able and willing to comply with all study requirements
Exclusion Criteria:
* Female participants who are of childbearing potential who are either unable or unwilling to use highly effective contraception, or who are pregnant or breast feeding
* History of hypersensitivity to 5-ALA, SFC and/or porphyrins
* Acute or chronic types of porphyria
* Known genetic haemochromatosis or clinically significant iron overload
* History of clinically significant photosensitization
* Current long-term (\> 3 months) use of amiodarone
* Concomitant use of hypericin extract (including St John's Wort) or concomitant therapeutic dose oral iron replacement
* Use of other investigational medical product(s) \< 28 days prior to study or 5 half-lives, whichever is longer
* Cardiogenic shock/Low cardiac output syndrome requiring catecholamine infusion and/or mechanical circulatory support prior to induction of anaesthesia for cardiac surgery
* Recent acute myocardial infarction
* Cardiac surgery without cardiopulmonary bypass or induced fibrillating heart surgery
* Inadequate renal or liver function
* Any other condition which, in the opinion of the Investigator, makes the patient unsuitable for or may compromise their participation in the study
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline HO-1 expression to time of cardiac surgery
Timeframe: Baseline at screening compared to post dose (measured within 12 hours of final dose, before cardiac surgery)
2
Number of Participants With Dose Limiting Toxicity