Evaluation of GeranylGeranylAcetone in heart failure with preserved ejection fractio

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

To be eligible to participate in this study, a subject must meet all of the
following criteria:
1. Age>= 50 years
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 > 2.8 m/s.
- Pulmonary capillary wedge pressure (PCWP) >15 mmHg and/or >25 mmHg during
exercise

Exclusion Criteria

1. Current acute decompensated heart failure, requiring hospitalization or
augmented therapy with intravenous diuretics, vasodilators, and/or inotropic
drugs
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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>7.9.1 Main study parameter/endpoint<br /><br>Co-primary objectives:<br /><br>1. Does GGA-treatment improve LV diastolic function in HFpEF, measured by<br /><br>echocardiography derived filling pressures (E/e*)?<br /><br>2. Does GGA-treatment improve endothelial function, measured by EndoPAT®-<br /><br>derived reactive hyperemia index (RHI)? </p><br>

Secondary Outcome Measures

Name	Time	Method

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