NCT05672134

Evaluation of GeranylGeranylAcetone in Heart Failure With Preserved Ejection Fraction

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Amsterdam UMC, location VUmc · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure With Preserved Ejection Fraction

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Iohexol measurement	Invasive renal hemodynamic measurement of mGFR through the administration of Iohexol.
DRUG	Geranylgeranylacetone (GGA)	13 weeks of treatment with GGA/placebo orally, followed by a wash-out period of 6 weeks, then reversal of the treatment arms.
DIAGNOSTIC_TEST	Echocardiography	The investigators will perform echocardiography to find changes in cardiac function.
DIAGNOSTIC_TEST	6-minute walking distance test	6 minute walking distance test to compare exercise tolerance in participants.
DIAGNOSTIC_TEST	EndoPAT	Use of EndoPAT to measure endothelial function.
DIAGNOSTIC_TEST	Para-amino Hippuric Acid test	PAH-measurement to measure ERPF.
DIAGNOSTIC_TEST	Electrocardiogram	12-lead Electrocardiogram

Timeline

• Start date: 2023-04-26
• Primary completion: 2024-08-30
• Completion: 2024-08-30
• First posted: 2023-01-05
• Last updated: 2025-04-01

Locations

1 site across 1 country: Netherlands