Effects of peroral levosimendan in the prevention of further hospitalisations in patients with chronic heart failure. A randomised, double-blind, placebo-controlled, multi-centre, parallel-group study - PERSIST
- Conditions
- Cardiac FailureMedDRA version: 7.1Level: LLTClassification code 10007554
- Registration Number
- EUCTR2004-004225-10-EE
- Lead Sponsor
- Orion Pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 300
1. Written Informed Consent obtained
2. Male and female patients over 18 years of age. Women of reproductive age and potential must refrain from breastfeeding, must have a negative pregnancy test and must commit to using an acceptable method of barrier or hormonal contraception (e.g. condoms, diaphragms, oral contraceptives and long acting progestin agents) if sexually active during the study and for 1 month after the last dose of the study
treatment. 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
3. Chronic heart failure diagnosed at least 3 months before screening
4. Treatment for at least 1 month before screening with angiotensin converting enzyme (ACE) inhibitor or beta-blocker and additionally at least one of the following: diuretics, digitalis, aldosterone antagonist or angiotensin II receptor blocker
5. Left ventricular ejection fraction less than or equal to 30% as assessed by echocardiography, radionuclide ventriculography or contrast angiography within 12 months before screening
6. NYHA IIIb-IV symptoms (dyspnoea on minimal exertion or at rest) at screening and at baseline
7. Further evidence of severely compromised heart failure as evidenced by one of the following at screening:
- History of at least one hospitalisation or visit to out-patient clinic for worsening heart failure requiring treatment either with intravenous (i.v.) diuretics, i.v. vasodilators, and/or i.v. inotropic agents within 6 months before screening; the index hospitalisation may be currently on-going at screening but if so, the patient must be ready to be discharged
- Plasma N-terminal-pro-B-type natriuretic peptide (NT-pro-BNP) above or equal to 1000 pg/ml at screening
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Severe obstruction of ventricular outflow tracts such as haemodynamically significant uncorrected primary valve disease or hypertrophic cardiomyopathy or impaired ventricular filling such as restrictive cardiomyopathy
2. Cardiac surgery or coronary angioplasty within 30 days before screening
3. Acute myocardial infarction within 30 days before screening
4. Patients who are scheduled to receive a heart transplant or left ventricular assist device or are scheduled for coronary by-pass or angioplasty in the next 6 months
5. History of life-threatening ventricular arrhythmia within 3 months defined as an episode of resuscitated sudden death, ventricular fibrillation or sustained or haemodynamically destabilising ventricular tachycardia (wide complex tachycardia >100/min, either for >15 seconds or accompanied by hypotension,
presyncope or syncope). Patients with one of these three arrhythmias may be enrolled if the episode was followed by placement of an intracardiac cardioverter-defibrillator (ICD) (and the ICD has not fired within 30 days)
6. History of Torsades de Pointes or family history of long QT-syndrome
7. Stroke or transient ischaemic attack within 3 months before screening
8. Systolic blood pressure less than 85 mmHg at screening and baseline
9. Heart rate 100 bpm or greater at screening and baseline
10. Serum potassium less than 3.5 mmol/l at screening
11. Severe renal insufficiency (serum creatinine >450 µmol/l [5.0 mg/dl]) or on dialysis
12. Severe anaemia (blood haemoglobin <10 g/dl) at screening
13. Significant hepatic impairment at discretion of the investigator
14. Hypersensitivity to levosimendan
15. Other serious diseases limiting life expectancy considerably (e.g. end-stage cancer)
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 30 days prior to screening
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method