Clinical study assessing safety and efficacy of Istaroxime in patients affected by acute cardiac insufficiency decompensated. Five centres will be involved. Each patient will receive, in a casual order, one of the two Istaroxime dosages or placebo and therefore there will be three different treatment groups. Nor the patients neither the doctors will know the treatment received/administered.

Phase 1

• Conditions: Acute heart failure decompensated; MedDRA version: 14.1Level: LLTClassification code 10066332Term: Acute cardiac insufficiencySystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2013-000540-26-IT
• Lead Sponsor: CVie Therapeutics Company Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-03-14
• Last Update Posted: 11 May 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Signed informed consent; 2. Male or female patients = 18 years; 3. Admission for a recurrent ADHF episode with dyspnea at rest or minimal exertion and need of intravenous diuretic therapy (>40 mg iv. furosemide); 4. Systolic blood pressure between 90 and 125 mmHg (limits included)
without signs or symptoms of hypoperfusion including cardiogenic shock, cold extremities and peripheral vasoconstriction, oliguria/anuria, signs of cerebral hypo perfusion such as confusion;
5. Left ventricular (LV) Ejection fraction (EF) = 40 % measured by 2D-Echocardiography. 6. E/Ea ratio >10
7. BNP = 350pg/mL or NT-pro-BNP =1400 pg/mL 8. Adequate echocardiography window (defined as visualization of at least
13/16 segment of the left ventricle);
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 18
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion Criteria

1. Pregnant or breast-feeding women (women of child bearing potential must
have the results of a negative pregnancy test recorded prior to study drug
administration); 2. Current (within 12 hours prior to screening) or planned (through the completion of study drug infusion) treatment with any iv. therapies,
including vasodilators (including nitrates or nesiritide), positive inotropic agents and vasopressors; 3. Current or need of mechanical support (intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, or any ventricular assist device);
4. Ongoing treatment with oral digoxin. Patient treated with digoxin within the last week, can be randomised if the plasma concentration of digoxin are tested before randomization and its value will be less than 0.5 ng/ml; 5. History of hypersensitivity to the study medication;
6. Diagnosis of cardiogenic shock within the past month; 7. Acute coronary syndrome or stroke within the past 3 months; 8. Coronary artery bypass graft or percutaneous coronary intervention within the past month or planned in the next month; 9. Primary hypertrophic or restrictive cardiomyopathy or systemic illness known to be associated with infiltrative heart disease; 10. Cor pulmonale or other causes of right-sided HF not related to left ventricular dysfunction;
11. Pericardial constriction or active pericarditis; 12. Atrial fibrillation with market irregularities of heart rhythm;
13. Life threatening ventricular arrhythmia or ICD (implantable cardioverter
defibrillator) shock within the past month;
14. CRT (cardiac resynchronization therapy), ICD or pacemaker implantation
within the past month; 15. Valvular disease as primary cause of HF; 16. Heart rate >120 bpm or < 50 bpm; 17. Acute respiratory distress syndrome or ongoing sepsis; 18. Fever >38°; 19. History of bronchial asthma or porphyria;
20. Donation or loss of blood equal to or exceeding 500 mL, during the 8 weeks before administration of study medication;
21. Positive testing for HIV, Hepatitis B and/or Hepatitis C; 22. Participation in another interventional study within the past 30 days; 23. The following laboratory exclusion criteria, verified based on results
obtained within the last 24 hours of hospitalization: a. Serum creatinine > 3.0 mg/dl (> 265 µmol/L); b. Aspartate aminotransferase (ASAT) or alanine aminotransferase (ALAT) > 3 x upper limit of normal, c. Hemoglobin (Hb) < 10 g/dL,
d. Platelet count < 100,000/µL, e. Serum potassium > 5.3 mmol/L or < 3.8 mmol/L.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified