Patients with acute decompensated heart failure. MedDRA version: 9.1 Level: LLT Classification code 10060953 Term: Ventricular failure
Conditions
Interventions
Trade Name: SIMDAX
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Levosimendan
Other descriptive name: levosimendan
Concentration unit: µg microgram(s)
Concentration t
Sponsors
AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. An ejection fraction (EF) lower than 40% by transthoracic echocardiogram by Simpson`s rule. 2. Wedge pressure (PCWP) higher than 20 mmHg. 3. Mild-moderate renal impairment. 4. A Standard therapy for HF that should include angiotensin converting enzyme inhibitors, angiotensin receptor blockers, aldosterone blocking agents (spironolactone) and beta-blockers, unless controindicated 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
Exclusion criteria
Exclusion criteria: 1. Patients receiving other oral or i.v. inodilators. 2. Oral or i.v. diuretics. 3. Patients with systolic blood pressure <110 mmHg. 4. Mechanical ventilation. 5. Sustained ventricular tachycardia or ventricular fibrillation. 6. Severe aortic or mitral regurgitation. 7. Documented renal artery stenosis, requiring dyalisis. 8. Left ventricular failure primarily from uncorrected obstructive valvular disease, hypertrophic obstructive cardiomyopathy, restrictive/obstructive cardiomyopathy. 9. Uncorrected thyroid disease, 10. Known amyloid cardiomiopathy 11. Known malfunctioning artificial heart valve.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect on renal function of Levosimendan infusion in addition to standard therapy, compared to standard therapy alone.;Secondary Objective: To evaluate the effect of Levosimendan, in addition to standard therapy, on systemic and regional (renal) hemodynamic parameters, compared to standard therapy alone.;Primary end point(s): GFR measured by inulin Clearance. | — |
Countries
Italy
Outcome results
None listed