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Treatment With 5-AminoLEvuliNic Acid Before Cardiac Surgery | Clinical Trials | Clareo Health

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Treatment With 5-AminoLEvuliNic Acid Before Cardiac Surgery

Pre-operative 5-Aminolevulinic Acid to Activate Haem Oxygenase to Improve Outcomes in Cardiac Surgery: A Dose Finding Study

NCT07027670•University of Oxford

View on ClinicalTrials.gov

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.

Detailed Description

TALEN is a prospective, randomised, double blind, placebo-controlled phase 2 study of 5-ALA-SFC administration in adults undergoing non-emergent cardiac surgery on CPB examining the potential of 5-ALA-SFC to induce haem oxygenase-1 (HO-1) as a novel cardio- and cyto-protective strategy for clinical benefit. 5-ALA is an amino acid found in several foods and a natural endogenous precursor in the synthesis of haem. Oral administration of 5-ALA-SFC has been shown to be safe and to induce a pharmacodynamic effect on the key effector, HO-1. TALEN is designed as a dose-finding trial with sequential dose cohorts, evaluating the safety, tolerability and PD response to 5-ALA-SFC to determine the optimum biological dose for further evaluation.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+3 more criteria

Locations (1)

John Radcliffe Hospital

Oxford, Oxfordshire, United Kingdom

Key Dates

Start Date

February 1, 2021

Primary Completion Date

June 30, 2022

Completion Date

June 30, 2022

Last Updated

June 25, 2025

Enrollment

ACTUAL participants

Conditions

Cardiac Surgical ProceduresCoronary Artery BypassAortic Valve DiseaseMitral Valve Disease

Interventions

5-Aminolevulinic Acid hydrochloride (5-ALA)

DRUG

Placebo

OTHER

Sodium ferrous citrate (SFC)

DRUG

SAvvywire for Pacing and Procedural Hemodynamics In Transcatheter Aortic Valve Replacement Evaluation

NCT07366671

TAVI(Transcatheter Aortic Valve Implantation)Aortic Valve Disease

View study

RECRUITINGNA

J-Valve Transfemoral Pivotal Study

NCT06455787

Aortic Valve RegurgitationAortic Valve Disease Mixed

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 25, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Treatment With 5-AminoLEvuliNic Acid Before Cardiac Surgery

Inclusion Criteria

Exclusion Criteria

SAvvywire for Pacing and Procedural Hemodynamics In Transcatheter Aortic Valve Replacement Evaluation

J-Valve Transfemoral Pivotal Study

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