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 |