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NCT05672134: GLADIATOR

Evaluation of GeranylGeranylAcetone in Heart Failure With Preserved Ejection Fraction

Completed Phase 2 Last updated 1 April 2025
What this trial tests

Phase 2 trial testing Iohexol measurement in Heart Failure With Preserved Ejection Fraction in 43 participants. Completed in 30 August 2024.

Timeline
26 April 2023
Primary endpoint
30 August 2024
30 August 2024

Quick facts

Lead sponsorAmsterdam UMC, location VUmc
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingquadruple
Primary purposetreatment
Enrollment43
Start date26 April 2023
Primary completion30 August 2024
Estimated completion30 August 2024
Sites1 location across Netherlands

Drugs / interventions tested

Conditions studied

Sponsor

Amsterdam UMC, location VUmc — full company profile →

Who can join

50 and older, any sex, with Heart Failure With Preserved Ejection Fraction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this double-blind randomized, placebo-controlled cross-over trial is to evaluate the effectiveness of GerenylGeranylAcetone (GGA) in patients with Heart Failure with a preserved ejection fraction. The main questions it aims to answer are: * What is the effect of GGA on diastolic function? * What is the effect of GGA on endothelial function? Main study tasks: * Participants will be treated with either GGA or placebo for 13 weeks. After this they will have a break (wash-out) period for 6 weeks and then cross over to the other study arm. * Cardiac function will be measured using echocardiogram in all participants * Renal measurements and endothelial measurements will be performed on the participants. * Participants will perform a 5 minute walking distance test for functional capacity. * Participants will fill out questionnaires to score signs \& symptoms. Researchers will compare the patients to themselves to see if the drug improves diastolic- and endothelial function.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Effects of geranylgeranylacetone on diastolic and microvascular function in patients with heart failure with a preserved ejection fraction: A phase 2, randomized, placebo-controlled, crossover trial.
    Nassiri S, Voordes GHD, van Heerebeek L, van Raalte DH, et al · · 2025 · cited 2× · PMID 40719441 · DOI 10.1002/ejhf.3711

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Other recruiting trials for Heart Failure With Preserved Ejection Fraction

Currently open trials in the same condition.

Other Amsterdam UMC, location VUmc trials

Trials by the same sponsor.

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Data sources for this page

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/NCT05672134.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing