Evaluation of GeranylGeranylAcetone in Heart Failure With Preserved Ejection Fraction

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

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

Sponsors & Collaborators

• Amsterdam UMC, location VUmc

  lead OTHER

Principal Investigators

• Louis Handoko, MD, PhD · Amsterdam University Medical Center

• Adriaan Voors, MD, PhD · University Medical Center Groningen

• Loek van Heerebeek, MD, PhD · Onze Lieve Vrouwe Gasthuis, Amsterdam

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

CROSSOVER

Eligibility

Min Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-04-26

Primary Completion

2024-08-30

Completion

2024-08-30

Countries

• Netherlands

Study Locations