DRKS00014953CompletedPhase 3
REPETITIVE LEVOSIMENDAN INFUSIONSFOR PATIENTS WITH ADVANCED CHRONIC HEART FAILURE - LeoDOR
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 149
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized controlled study
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 18 Years to 99 Years (—)
- Sex
- All
Inclusion Criteria
- •1. Written, signed and dated informed consent.
- •2. Male and female patients over 18 years of age.
- •3. Women of childbearing potential must have a monthly negative pregnancy test and must
- •refrain from breastfeeding. Women who are postmenopausal (1 year since last menstrual
- •cycle), surgically sterilised or who have undergone a hysterectomy are considered not to be of
- •childbearing potential.
- •4. CHF diagnosed at least 6 months before screening and treated with individually optimised
- •long-term oral treatment for the last month, unless not tolerated (e.g., ACE-inhibitor or AT II
- •blocker, beta-blocker, mineralocorticoid receptor antagonist, angiotensin II receptor blocker
- •neprilysin inhibitor [ARNI] and with devices [e.g., CRT/ICD], as needed).
- •5. Left ventricular ejection fraction less than or equal to 30% as assessed by echocardiography,
- •radionuclide ventriculography or contrast angiography within the index hospitalisation.
- •6. Currently hospitalised for decompensated HF requiring i.v. diuretics, or i.v. vasodilators, or i.v.
- •inotropic therapy, or their combination.
- •7. Previous hospitalisation or visit to outpatient clinic requiring i.v. diuretics, i.v. vasodilators, or i.v.
- •inotropic therapy, or their combination for acute decompensated HF within 12 months before
- •the current hospitalisation.
- •8. NT-proBNP level (as measured by the local laboratory) after recompensation of 2500 ng/L
- •(BNP 900 ng/L) and/or NYHA class III or IV at study entry.
Exclusion Criteria
- •1. Severe obstruction of ventricular outflow tract such as haemodynamically significant
- •uncorrected primary valve disease or hypertrophic cardiomyopathy or impaired ventricular
- •filling such as restrictive cardiomyopathy
- •2. Predominantly right heart failure and/or severe tricuspid regurgitation
- •3. Cardiac surgery or coronary angioplasty within 30 days before study drug initiation
- •4. Acute coronary syndrome within 30 days before study drug initiation
- •5. Patients who are scheduled for cardiac surgery or angioplasty in the next 3 months
- •6. History of torsades de pointes
- •7. Stroke or transient ischaemic attack (TIA) within 3 months before study drug initiation
- •8. Systolic blood pressure less than 90 mmHg at baseline
- •9. Heart rate 120 bpm or greater at baseline
- •10. Serum potassium less than 3.5 mmol/l before study drug initiation
- •11. Severe renal insufficiency (estimated glomerular filtration rate [eGFR] less than 30
- •ml/min/1.73m2)
- •12. Anaemia (haemoglobin less than 10 g/dl)
- •13. Significant hepatic impairment at the discretion of the investigator
- •14. Hypersensitivity to levosimendan
- •15. Other serious diseases limiting life expectancy considerably (e.g. end-stage cancer, end-stage
- •renal disease, end-stage lung disease)
- •16. Participation in a clinical trial with any experimental treatment within 30 days prior to screening
- •or previous participation in the present study
- •17. Administration of levosimendan within 14 days prior the study drug initiation (the first study
- •drug application has to be postponed for at least 14 days after the end of this premedication)
- •18. Suspected non-compliance
- •19. Pregnant woman and nursing mother
- •20. Failure to use highly effective (Pearl Index lower than 1%) contraceptive methods
- •21. Person with any kind of dependency on the investigator
- •22. Person held in an institution by legal or official order
Investigators
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