Renal Effects of Levosimendan in Patients Admitted with Acute Decompensated Heart Failure - ND

Conditions: Patients with acute decompensated heart failure.
MedDRA version: 9.1Level: LLTClassification code 10060953Term: Ventricular failure

Registration Number: EUCTR2007-002431-80-IT

Lead Sponsor: AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures