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. 2019 Mar 20;21(5):676–684. doi: 10.1002/ejhf.1452

Table 1.

Inclusion criteria

1. Signed written informed consent and willingness to comply with treatment and follow‐up
2. Male and female patients aged ≥ 18 years at the day of inclusion
3. Capable to understand the investigational nature, potential risks and benefits of the clinical trial
4. Chronic heart failure with symptoms compatible with New York Heart Association functional class III–IV and a left ventricular ejection
fraction ≤ 40%, or New York Heart Association functional class II with left ventricular ejection fraction ≤ 30% (determined at screening by
echocardiography or cardiac magnetic resonance tomography or within 8 weeks prior to study inclusion by left ventricular angiography,
echocardiography, radionuclide ventriculography, cardiac magnetic resonance tomography)
AND
a heart failure therapy based on current ESC guideline recommendations for a duration of at least 6 months upon
discretion of the treating physician
5. Women without childbearing potential defined as one or more of the following:
a. Women at least 6 weeks after surgical sterilization by bilateral tubal ligation or bilateral oophorectomy with or without hysterectomy at theday of inclusion
b. Women ≥ 50 years of age at the day of inclusion who have been postmenopausal since at least 1 year
c. Women < 50 years and in postmenopausal state ≥ 1 year with serum FSH > 40 IU/L (ascertained by a second laboratory assessment after 4 weeks)
OR
Women of childbearing potential who have a negative hCG pregnancy test and agree to meet one or more of the following
criteria from the time of screening/baseline, during the study and for a period of 40 days following the last administration of study medication:
a. Correct use of reliable contraception methods. This includes hormonal contraceptive (oral contraceptives, implants, transdermal patches,hormonal vaginal devices or injections with prolonged release) or an intrauterine device/system or a barrier method of contraception suchas condom or occlusive cap (diaphragm or cervical/vault caps) with spermicide (foam/gel/film/cream/suppository)
b. True abstinence (periodic abstinence and withdrawal are not acceptable methods of contraception)
c. Sexual relationship only with female partners and/or sterile male partnersORMen