Renal Effects of Levosimendan in Patients Admitted With Acute Decompensated Heart Failure

• Status: Unknown status
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effect of levosimendan infusion, in addition to standard therapy,on renal function in patients with Acute Heart Failure,compared with standard therapy alone.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Roma La Sapienza
• Treatments: Adrenergic beta-Antagonists; Simendan; Spironolactone

Criteria

Inclusion Criteria:

• an ejection fraction (EF) 40% by transthoracic echocardiogram,

• a baseline pulmonary capillary wedge pressure (PCWP) 20 mm Hg

• a MDRD (Modification of Diet Renal Disease) score > 30 and < 60

• and a standard therapy for HF that should include angiotensin converting enzyme inhibitors, angiotensin receptor blockers, aldosterone blocking agents (spironolactone) and beta-blockers, unless contraindicated

Exclusion Criteria:

• patients receiving other oral or i.v. inotropes,

• oral or i.v. diuretics

• or receiving nitroglycerine or nitroprusside,

• patients with systolic blood pressure <110 mmHg,

• mechanical ventilation,

• anticipated survival <30 days,

• absence of thoracic windows for echocardiography,

• acute coronary syndromes,

• sustained ventricular tachycardia or ventricular fibrillation,

• documented renal artery stenosis, requiring dialysis,

• requiring admission primarily for concurrent morbidity,

• severe aortic or mitral regurgitation,

• left ventricular failure primarily from uncorrected obstructive valvular disease, hypertrophic obstructive cardiomyopathy, restrictive/obstructive cardiomyopathy,

• uncorrected thyroid disease,

• known amyloid cardiomyopathy

• or known malfunctioning artificial heart valve.