Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2026-01-22 @ 1:23 PM
Study NCT ID:
NCT05672134
Status:
COMPLETED
Last Update Posted:
2025-04-01
First Post:
2022-06-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of GeranylGeranylAcetone in Heart Failure With Preserved Ejection Fraction
Sponsor:
Amsterdam UMC, location VUmc
Organization:
Study Overview
Official Title:
Evaluation of GeranylGeranylAcetone in Heart Failure With Preserved Ejection Fraction
Status:
COMPLETED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GLADIATOR
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: