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 |
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fraction ≤ 40%, or New York Heart Association functional class II with left ventricular ejection fraction ≤ 30% (determined at screening by |
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echocardiography or cardiac magnetic resonance tomography or within 8 weeks prior to study inclusion by left ventricular angiography, |
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echocardiography, radionuclide ventriculography, cardiac magnetic resonance tomography) |
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AND |
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a heart failure therapy based on current ESC guideline recommendations for a duration of at least 6 months upon |
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discretion of the treating physician |
5. |
Women without childbearing potential defined as one or more of the following: |
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a. Women at least 6 weeks after surgical sterilization by bilateral tubal ligation or bilateral oophorectomy with or without hysterectomy at theday of inclusion |
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b. Women ≥ 50 years of age at the day of inclusion who have been postmenopausal since at least 1 year |
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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) |
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OR |
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Women of childbearing potential who have a negative hCG pregnancy test and agree to meet one or more of the following |
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criteria from the time of screening/baseline, during the study and for a period of 40 days following the last administration of study medication: |
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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) |
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b. True abstinence (periodic abstinence and withdrawal are not acceptable methods of contraception) |
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c. Sexual relationship only with female partners and/or sterile male partnersORMen |