Last reviewed · How we verify
NCT05672134: GLADIATOR
Evaluation of GeranylGeranylAcetone in Heart Failure With Preserved Ejection Fraction
Phase 2 trial testing Iohexol measurement in Heart Failure With Preserved Ejection Fraction in 43 participants. Completed in 30 August 2024.
30 August 2024
Quick facts
| Lead sponsor | Amsterdam UMC, location VUmc |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 43 |
| Start date | 26 April 2023 |
| Primary completion | 30 August 2024 |
| Estimated completion | 30 August 2024 |
| Sites | 1 location across Netherlands |
Drugs / interventions tested
- Iohexol measurement
- Geranylgeranylacetone (GGA) — full drug profile →
- Echocardiography
- 6-minute walking distance test
- EndoPAT
- Para-amino Hippuric Acid test
- Electrocardiogram
Conditions studied
- Heart Failure With Preserved Ejection Fraction — all drugs for Heart Failure With Preserved Ejection Fraction →
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):
-
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
Verify or expand the search:
- PubMed search for NCT05672134
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Heart Failure With Preserved Ejection Fraction
Currently open trials in the same condition.
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- NCT07037459 — Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity · Phase 3 · recruiting
- NCT06702501 — The PeriCut Catheter System Early Feasibility Study (REIMAGINE-HFpEF) · NA · recruiting
- NCT06616974 — A Study of TX000045 in Patients With Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction · Phase 2 · recruiting
Other Amsterdam UMC, location VUmc trials
Trials by the same sponsor.
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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 NCT05672134 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Amsterdam UMC, location VUmc
- Last refreshed: 1 April 2025
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