Evaluation of GeranylGeranylAcetone in Heart Failure With Preserved Ejection Fraction
NCT ID: NCT05672134
Last Updated: 2025-04-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
43 participants
INTERVENTIONAL
2023-04-26
2024-08-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Single Ascending Doses of GGF2 in Patients With Left Ventricular Dysfunction and Symptomatic Heart Failure
NCT01258387
Dapagliflozin With or Without Spironolactone for HFpEF
NCT05676684
A Multi-center, Placebo-controlled Study to Evaluate the Safety of GSK716155 and Its Effects on Myocardial Metabolism, Myocardial Function, and Exercise Capacity in Patients With NYHA Class II/III Congestive Heart Failure
NCT01357850
Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients With Chronic Heart Failure
NCT03036124
Evaluation of Enalapril Versus Placebo in Patients With Diastolic Heart Failure
NCT01411735
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Experimental arm
Patients will receive 13 weeks of experimental treatment, followed by a 7 week wash-out period, continuing with 13 weeks of placebo as per crossover design.
Iohexol measurement
Invasive renal hemodynamic measurement of mGFR through the administration of Iohexol.
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.
Echocardiography
The investigators will perform echocardiography to find changes in cardiac function.
6-minute walking distance test
6 minute walking distance test to compare exercise tolerance in participants.
EndoPAT
Use of EndoPAT to measure endothelial function.
Para-amino Hippuric Acid test
PAH-measurement to measure ERPF.
Electrocardiogram
12-lead Electrocardiogram
Placebo arm
Patients will receive 13 weeks of placebo treatment, followed by a 7 week wash-out period, continuing with 13 weeks of experimental treatment as per crossover design.
Iohexol measurement
Invasive renal hemodynamic measurement of mGFR through the administration of Iohexol.
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.
Echocardiography
The investigators will perform echocardiography to find changes in cardiac function.
6-minute walking distance test
6 minute walking distance test to compare exercise tolerance in participants.
EndoPAT
Use of EndoPAT to measure endothelial function.
Para-amino Hippuric Acid test
PAH-measurement to measure ERPF.
Electrocardiogram
12-lead Electrocardiogram
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Iohexol measurement
Invasive renal hemodynamic measurement of mGFR through the administration of Iohexol.
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.
Echocardiography
The investigators will perform echocardiography to find changes in cardiac function.
6-minute walking distance test
6 minute walking distance test to compare exercise tolerance in participants.
EndoPAT
Use of EndoPAT to measure endothelial function.
Para-amino Hippuric Acid test
PAH-measurement to measure ERPF.
Electrocardiogram
12-lead Electrocardiogram
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Patients with a diagnosis of symptomatic chronic heart failure (New York Heart Association class II or III) AND preserved systolic LV function (LV ejection fraction or LVEF ≥ 50%) documented within the last 6 months AND evidence of diastolic LV dysfunction with at least 1 out of the following 4 criteria:
* HFA-PEFF score ≥5
* H2FPEF score ≥6
* HFpEF according to the 2021 ESC HF Guidelines (NT-proBNP\>125 pg/ml AND either LV mass indexed or LVMI \>95 g/m2 for women and \>115 g/m2 for men OR left atrial volume indexed or LAVI \>34 ml/m2 OR mean e; septal/lateral \< 9 cm/s) OR E/e' \>13 OR TR velocity at rest \>2,8m/s.
* Pulmonary capillary wedge pressure (PCWP) \>15 mmHg and/or \>25 mmHg during exercise.
Exclusion Criteria
2. Acute coronary syndrome, transient ischemic attack/cerebrovascular accident, major surgery within the previous 3 months
3. Hemoglobin \<9 g/dl at screening
4. LVEF \<40% measured at any time point in the history of the patient
5. History of mitral valve repair or replacement
6. Presence of significant valvular disease defined as mitral valve regurgitation defined as grade ≥ 3+ MR; tricuspid valve regurgitation defined as grade ≥ 2+ TR; aortic valve disease defined as ≥ 2+ AR or \> moderate AS
7. Acute myocarditis within 3 months prior to randomization
8. Infiltrative cardiomyopathy
9. Genetic cardiomyopathy
10. Severe pulmonary disease requiring home oxygen or chronic oral steroid therapy
11. Precapillary pulmonary hypertension
12. BMI \>40 kg/m2
13. Estimated glomerular filtration rate (GFR) \<20 ml/min or \>90 ml/min
14. History of solid organ transplantation including kidney transplantation
15. Atrial fibrillation or atrial flutter with resting ventricular rate \>110 bpm
16. Not able to undergo the complete study protocol
17. Doubt about compliance
18. Pre-menopausal women who are nursing, pregnant, or of child-bearing potential and not practicing an acceptable method of birth control
19. Chronic absorption problems
20. Proven allergy for lactose products or cow-milk.
21. Proven allergy for Iodide-containing contrast, Iohexol or PAH.
22. Any documented or suspected malignancy or history of malignancy within 1 year prior to screening, except appropriately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix
23. Currently enrolled in another investigational device or drug trial
24. Estimated life expectancy \<1 year
50 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Amsterdam UMC, location VUmc
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
M. Louis Handoko
MD, PhD, Principal investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Louis Handoko, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Amsterdam University Medical Center
Adriaan Voors, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Medical Center Groningen
Loek van Heerebeek, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Onze Lieve Vrouwe Gasthuis, Amsterdam
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Amsterdam UMC, loc VUmc
Amsterdam, North Holland, Netherlands
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NL 80684
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.