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

NCT ID: NCT00527059

Last Updated: 2007-09-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2008-03-31

Brief 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.

Detailed 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.

Conditions

Heart Failure; Renal Insufficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

patients with acute heart failure

Group Type: EXPERIMENTAL

Levosimendan in addition to standard therapy

Intervention Type: DRUG

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

2

standard therapy for heart failure

Group Type: ACTIVE_COMPARATOR

spironolactone, beta-blockers,ecc

Intervention Type: DRUG

Interventions

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

Intervention Type: DRUG

spironolactone, beta-blockers,ecc

Intervention Type: DRUG

Eligibility 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Roma La Sapienza

OTHER

Sponsor Role: lead

Principal Investigators

Francesco Fedele, professor

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiovascular, Respiratory and Morphological Sciences, University of Rome La Sapienza

Locations

Department of Cardiovascular, Respiratory and Morphological Sciences, University of Rome La Sapienza

Rome, Viale Del Policlinico 155, , Italy

Countries

Italy

Central Contacts

Francesco Fedele, professor

Role: CONTACT

francesco.fedele@uniroma1.it

0039-0649979020

References

Fedele F, Bruno N, Brasolin B, Caira C, D'Ambrosi A, Mancone M. Levosimendan improves renal function in acute decompensated heart failure: possible underlying mechanisms. Eur J Heart Fail. 2014 Mar;16(3):281-8. doi: 10.1002/ejhf.9. Epub 2013 Dec 11.

Reference Type: DERIVED

PMID: 24464960 (View on PubMed)

Other Identifiers

LEV1068

Identifier Type: -

Identifier Source: org_study_id