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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00527059
• Other study ID #: LEV1068
• Status: Not yet recruiting
• Phase: Phase 4
• First received: September 7, 2007
• Last updated: September 7, 2007
• Start date: October 2007
• Est. completion date: March 2008

Study information

• Verified date: September 2007
• Source: University of Roma La Sapienza
• Contact: Francesco Fedele, professor
• Phone: 0039-0649979020
• Email: francesco.fedele[@]uniroma1.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 21
• Est. completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure
• Renal Insufficiency

Intervention

Drug:
• Levosimendan in addition to standard therapy
intravenous infusion of levosimendan (10 minutes bolus with 6 mcg/Kg according to physician judgement, followed by 0.1 mcg/Kg/min for 24 hours) in addition to standard therapy
• spironolactone, beta-blockers,ecc

Locations

Country	Name	City	State
Italy	Department of Cardiovascular, Respiratory and Morphological Sciences, University of Rome La Sapienza	Rome, viale del Policlinico 155

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary endpoint: GFR measured by inulin Clearance.		0, 24. 48 and 72 hours after Levosimendan infusion starting
Secondary	Secondary endpoints: •Other renal function measures: BUN, albumin, urine volume, sodium excretion and plasma sodium, and cystatin. •Hemodynamic parameters: PCWP, PAP, cardiac output, HR, BP, renal blood flow.		0,1,24,48 and 72 hours after Levosimendan infusion started