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

University of Roma La Sapienza

Status and phase

Unknown

Phase 4

Conditions

Renal Insufficiency

Heart Failure

Treatments

Drug: spironolactone, beta-blockers,ecc

Drug: Levosimendan in addition to standard therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT00527059

LEV1068

Details and patient eligibility

About

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.

Full description

The term "cardiorenal syndrome" has been applied to the presence or development of a renal dysfunction in HF patients and may be the major precipitant of decompensation and cause for admission in these patients. The renal hypoperfusion that occurs with cardiac injury can lead to sodium and water retention and activation of the renin-angiotensin-aldosterone system and neurohormonal pathways with resultant deleterious effects on the myocardium. A vicious cycle may then ensue and be associated with increased cardiovascular complications. In this regard, renal dysfunction is of a functional nature and thus means to intervene with this vicious cycle need to be sought.

Several studies already demonstrated the deleterious effects of renal dysfunction on prognosis in patients with HF due to chronic left ventricular dysfunction.

Levosimendan increases myocardial contractility without significant changes in the intracellular calcium ion and cyclic adenosine monophosphate concentrations and does not enhance myocardial oxygen demand. By its action on the potassium channels this drug also dilates the coronary and peripheral arteries and exerts an anti-ischemic,anti-stunning effect. To date, the effects of levosimendan on renal function in patients with worsening chronic HF, remain unknown.

Enrollment

21 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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.